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Frank P. Cammisa - One of the best experts on this subject based on the ideXlab platform.
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prospective randomized multicenter food and drug administration investigational device exemption study of the proDisc l Total Disc Replacement compared with circumferential arthrodesis for the treatment of two level lumbar degenerative Disc disease r
Journal of Bone and Joint Surgery American Volume, 2011Co-Authors: Rick B Delamarter, Frank P. Cammisa, Jack E. Zigler, Richard A. Balderston, Jeffrey A Goldstein, Jeffrey M SpivakAbstract:Background: Disc Replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative Disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L Total Disc Replacement as compared with spinal fusion for the treatment of degenerative Disc disease at two contiguous vertebral levels from L3 to S1. Methods: A Total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of Total Disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively. Results: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the Total Disc Replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the Total Disc Replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a ≥15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the Total Disc Replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the Total Disc Replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-four months). Visual analog scale scores for satisfaction significantly favored Total Disc Replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the Total Disc Replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded “yes” when asked if they would have the same surgery again. Lumbar spine range of motion on radiographs averaged 7.8° at the superior Disc and 6.2° at the inferior Disc in patients with Total Disc Replacement. Reduction in narcotics usage significantly favored the Total Disc Replacement group at twenty-four months after surgery (p = 0.0020). Conclusions: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar Disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
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Lumbar Total Disc Replacement
Journal of Bone and Joint Surgery American Volume, 2006Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:BACKGROUND: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. METHODS: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. RESULTS: At an average of 8.7 years post-operatively, there were significant improvements in the backpain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. CONCLUSIONS: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed.
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lumbar Total Disc Replacement part i rationale biomechanics and implant types
Orthopedic Clinics of North America, 2005Co-Authors: Peter Frelinghuysen, Russel C. Huang, Federico P. Girardi, Frank P. CammisaAbstract:Degenerative Disc disease produces back pain that is often treated by nonsurgical methods. When these methods fail, surgical treatment is offered, usually in the form of interbody fusion. The concept of eliminating the painful motion segment by Discectomy and fusion is considered the ‘‘gold standard’’ of surgical treatment of recalcitrant degenerative Disc disease; however, the results of this surgical intervention are sometimes suboptimal in terms of pain relief and associated problems such as pseudoarthrosis, iliac crest bone graft donor site pain, and adjacent-level degeneration. Total Disc Replacement (TDR) has been developed to preserve motion, avoid the morbidity of bone graft harvest, and possibly reduce adjacent-level degeneration. Although preliminary reports on Disc Replacement have been promising, it should be emphasized that until longer-term follow-up data are available, the technology should not be widely applied in lieu of fusion.
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Lumbar Total Disc Replacement. Seven to eleven-year follow-up.
The Journal of bone and joint surgery. American volume, 2005Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:Background: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. Methods: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and postoperative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. Results: At an average of 8.7 years postoperatively, there were significant improvements in the back-pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. Conclusions: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
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The prevalence of contraindications to Total Disc Replacement in a cohort of lumbar surgical patients.
Spine, 2004Co-Authors: Russel C. Huang, Moe R. Lim, Federico P. Girardi, Frank P. CammisaAbstract:STUDY DESIGN This is a retrospective review of the epidemiology of contraindications to lumbar Total Disc Replacement (TDR). OBJECTIVE To define the prevalence of contraindications to lumbar Total Disc Replacement in a cohort of patients undergoing lumbar surgery in the senior author's (F.P.C.) practice. SUMMARY OF BACKGROUND DATA No published reports have documented the prevalence of contraindications to lumbar Total Disc Replacement. METHODS We performed a retrospective review of 100 consecutive patients who had lumbar surgery by one surgeon between September and December 2002. Procedures performed and contraindications to TDR were recorded. Contraindications to TDR included central or lateral recess stenosis, facet arthrosis, spondylolysis or spondylolisthesis, herniated nucleus pulposus with radiculopathy, scoliosis, osteoporosis, and postsurgical pseudarthrosis or deficiency of posterior elements. Patients were divided into fusion and nonfusion groups. The percentage of patients without contraindications to TDR was calculated. RESULTS Of 100 patients, 56 had fusions and 44 had nonfusion surgery. In the fusion group, 56 of 56 patients had contraindications to TDR. In the nonfusion group, 11% (5 of 44) were candidates for TDR. Overall, 5% of patients in this series were candidates for TDR. The average number of contraindications to TDR was 2.48 (range, 0-5). CONCLUSIONS Predictions that TDR will replace fusion are premature. A small percentage (5%) of the patients currently indicated for lumbar surgery at our institution have no contraindications to TDR. Future growth in TDR implantation will result from the indication of patients for surgery who would not be indicated today or from the elimination of current contraindications.
Federico P. Girardi - One of the best experts on this subject based on the ideXlab platform.
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lumbar Total Disc Replacement for Discogenic low back pain two year outcomes of the activl multicenter randomized controlled ide clinical trial
Spine, 2015Co-Authors: Rolando Garcia, Scott L. Blumenthal, Glenn R. Buttermann, James J. Yue, Dom Coric, Vikas V Patel, Scott P Leary, Dzung H Dinh, Harel Deutsch, Federico P. GirardiAbstract:Study Design.A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.Objective.The aim of this study was to evaluate the comparative safety and effectiveness of lumbar Total Disc Replacement (TDR) in the treatment of patients with symptomatic d
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Lumbar Total Disc Replacement
Journal of Bone and Joint Surgery American Volume, 2006Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:BACKGROUND: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. METHODS: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. RESULTS: At an average of 8.7 years post-operatively, there were significant improvements in the backpain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. CONCLUSIONS: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed.
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lumbar Total Disc Replacement part i rationale biomechanics and implant types
Orthopedic Clinics of North America, 2005Co-Authors: Peter Frelinghuysen, Russel C. Huang, Federico P. Girardi, Frank P. CammisaAbstract:Degenerative Disc disease produces back pain that is often treated by nonsurgical methods. When these methods fail, surgical treatment is offered, usually in the form of interbody fusion. The concept of eliminating the painful motion segment by Discectomy and fusion is considered the ‘‘gold standard’’ of surgical treatment of recalcitrant degenerative Disc disease; however, the results of this surgical intervention are sometimes suboptimal in terms of pain relief and associated problems such as pseudoarthrosis, iliac crest bone graft donor site pain, and adjacent-level degeneration. Total Disc Replacement (TDR) has been developed to preserve motion, avoid the morbidity of bone graft harvest, and possibly reduce adjacent-level degeneration. Although preliminary reports on Disc Replacement have been promising, it should be emphasized that until longer-term follow-up data are available, the technology should not be widely applied in lieu of fusion.
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Lumbar Total Disc Replacement. Seven to eleven-year follow-up.
The Journal of bone and joint surgery. American volume, 2005Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:Background: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. Methods: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and postoperative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. Results: At an average of 8.7 years postoperatively, there were significant improvements in the back-pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. Conclusions: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
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The prevalence of contraindications to Total Disc Replacement in a cohort of lumbar surgical patients.
Spine, 2004Co-Authors: Russel C. Huang, Moe R. Lim, Federico P. Girardi, Frank P. CammisaAbstract:STUDY DESIGN This is a retrospective review of the epidemiology of contraindications to lumbar Total Disc Replacement (TDR). OBJECTIVE To define the prevalence of contraindications to lumbar Total Disc Replacement in a cohort of patients undergoing lumbar surgery in the senior author's (F.P.C.) practice. SUMMARY OF BACKGROUND DATA No published reports have documented the prevalence of contraindications to lumbar Total Disc Replacement. METHODS We performed a retrospective review of 100 consecutive patients who had lumbar surgery by one surgeon between September and December 2002. Procedures performed and contraindications to TDR were recorded. Contraindications to TDR included central or lateral recess stenosis, facet arthrosis, spondylolysis or spondylolisthesis, herniated nucleus pulposus with radiculopathy, scoliosis, osteoporosis, and postsurgical pseudarthrosis or deficiency of posterior elements. Patients were divided into fusion and nonfusion groups. The percentage of patients without contraindications to TDR was calculated. RESULTS Of 100 patients, 56 had fusions and 44 had nonfusion surgery. In the fusion group, 56 of 56 patients had contraindications to TDR. In the nonfusion group, 11% (5 of 44) were candidates for TDR. Overall, 5% of patients in this series were candidates for TDR. The average number of contraindications to TDR was 2.48 (range, 0-5). CONCLUSIONS Predictions that TDR will replace fusion are premature. A small percentage (5%) of the patients currently indicated for lumbar surgery at our institution have no contraindications to TDR. Future growth in TDR implantation will result from the indication of patients for surgery who would not be indicated today or from the elimination of current contraindications.
Russel C. Huang - One of the best experts on this subject based on the ideXlab platform.
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Lumbar Total Disc Replacement
Journal of Bone and Joint Surgery American Volume, 2006Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:BACKGROUND: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. METHODS: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and post-operative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. RESULTS: At an average of 8.7 years post-operatively, there were significant improvements in the backpain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. CONCLUSIONS: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed.
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lumbar Total Disc Replacement part i rationale biomechanics and implant types
Orthopedic Clinics of North America, 2005Co-Authors: Peter Frelinghuysen, Russel C. Huang, Federico P. Girardi, Frank P. CammisaAbstract:Degenerative Disc disease produces back pain that is often treated by nonsurgical methods. When these methods fail, surgical treatment is offered, usually in the form of interbody fusion. The concept of eliminating the painful motion segment by Discectomy and fusion is considered the ‘‘gold standard’’ of surgical treatment of recalcitrant degenerative Disc disease; however, the results of this surgical intervention are sometimes suboptimal in terms of pain relief and associated problems such as pseudoarthrosis, iliac crest bone graft donor site pain, and adjacent-level degeneration. Total Disc Replacement (TDR) has been developed to preserve motion, avoid the morbidity of bone graft harvest, and possibly reduce adjacent-level degeneration. Although preliminary reports on Disc Replacement have been promising, it should be emphasized that until longer-term follow-up data are available, the technology should not be widely applied in lieu of fusion.
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Lumbar Total Disc Replacement. Seven to eleven-year follow-up.
The Journal of bone and joint surgery. American volume, 2005Co-Authors: Patrick Tropiano, Russel C. Huang, Federico P. Girardi, Frank P. Cammisa, Thierry MarnayAbstract:Background: Symptomatic lumbar degenerative Disc disease is a challenging entity to treat. The results of arthrodesis may be compromised in the short term by pseudarthrosis and in the long term by pain at the iliac-crest donor site and by junctional degeneration. Total Disc Replacement has the potential to provide long-lasting relief to these patients. The purpose of this study was to present the clinical and radiographic results assessed seven to eleven years following a ProDisc Total lumbar Disc Replacement. Methods: Sixty-four patients had single or multiple-level implantation of a Total lumbar Disc Replacement between 1990 and 1993. The mean duration of follow-up was 8.7 years. Clinical results were evaluated by assessing preoperative and postoperative lumbar pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Preoperative and postoperative radiographs were evaluated as well. Subgroup analysis was performed to determine if gender, an age of less than forty-five years, previous surgery, or multilevel surgery had an effect on outcome. Results: At an average of 8.7 years postoperatively, there were significant improvements in the back-pain, radiculopathy, disability, and modified Stauffer-Coventry scores. Thirty-three of the fifty-five patients with sufficient follow-up had an excellent result, eight had a good result, and fourteen had a poor result. Neither gender nor multilevel surgery affected outcome. An age of less than forty-five years and prior lumbar surgery had small but significant negative effects on outcome. Radiographs did not demonstrate loosening, migration, or mechanical failure in any patient. Five patients had approach-related complications. Conclusions: The ProDisc lumbar Total Disc Replacement appears to be effective and safe for the treatment of symptomatic degenerative Disc disease. Gender and multilevel surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than forty-five years was associated with slightly worse outcomes. Longer follow-up of this cohort of patients and randomized trials comparing Disc Replacement with arthrodesis are needed. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
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The prevalence of contraindications to Total Disc Replacement in a cohort of lumbar surgical patients.
Spine, 2004Co-Authors: Russel C. Huang, Moe R. Lim, Federico P. Girardi, Frank P. CammisaAbstract:STUDY DESIGN This is a retrospective review of the epidemiology of contraindications to lumbar Total Disc Replacement (TDR). OBJECTIVE To define the prevalence of contraindications to lumbar Total Disc Replacement in a cohort of patients undergoing lumbar surgery in the senior author's (F.P.C.) practice. SUMMARY OF BACKGROUND DATA No published reports have documented the prevalence of contraindications to lumbar Total Disc Replacement. METHODS We performed a retrospective review of 100 consecutive patients who had lumbar surgery by one surgeon between September and December 2002. Procedures performed and contraindications to TDR were recorded. Contraindications to TDR included central or lateral recess stenosis, facet arthrosis, spondylolysis or spondylolisthesis, herniated nucleus pulposus with radiculopathy, scoliosis, osteoporosis, and postsurgical pseudarthrosis or deficiency of posterior elements. Patients were divided into fusion and nonfusion groups. The percentage of patients without contraindications to TDR was calculated. RESULTS Of 100 patients, 56 had fusions and 44 had nonfusion surgery. In the fusion group, 56 of 56 patients had contraindications to TDR. In the nonfusion group, 11% (5 of 44) were candidates for TDR. Overall, 5% of patients in this series were candidates for TDR. The average number of contraindications to TDR was 2.48 (range, 0-5). CONCLUSIONS Predictions that TDR will replace fusion are premature. A small percentage (5%) of the patients currently indicated for lumbar surgery at our institution have no contraindications to TDR. Future growth in TDR implantation will result from the indication of patients for surgery who would not be indicated today or from the elimination of current contraindications.
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The current status of lumbar Total Disc Replacement.
The Orthopedic clinics of North America, 2004Co-Authors: Russel C. Huang, Harvinder S. SandhuAbstract:Total Disc Replacement is an exciting technology that may one day replace fusion as the gold standard treatment for DDD, but it is currently an experimental procedure in the United States. Promising short- and mid-term results have been reported for TDR, but longer follow-up and randomized trials comparing TDR to fusion and nonsurgical treatment are needed to fully define the role of TDR in the spine surgeon's armamentarium. Short-term complication rates have been acceptably low, but in the long term the durability of TDR implants and the vertebral endplate will provide challenges. Finally, it is essential that practitioners understand that a limited subset of patients are good candidates for TDR and that inDiscriminate application of this technology will result in poor outcomes.
Wilco C Peul - One of the best experts on this subject based on the ideXlab platform.
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Total Disc Replacement for Chronic Discogenic Low Back Pain : A Cochrane Review
Spine, 2013Co-Authors: Wilco C H Jacobs, Niels A Van Der Gaag, Alexander Tuschel, Marinus De Kleuver, Wilco C Peul, A J Verbout, Moyo C. Kruyt, F. Cumhur OnerAbstract:STUDY DESIGN.: Systematic literature review. OBJECTIVE.: To assess the effect of Total Disc Replacement for chronic low back pain due to lumbar degenerative Disc disease compared with fusion or other treatment options. SUMMARY OF BACKGROUND DATA.: There is an increasing use in Disc Replacement devices for degenerative Disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear. METHODS.: A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing Total Disc Replacement with any other intervention for degenerative Disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences. RESULTS.: We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared Disc Replacement with rehabilitation and found a significant advantage in favor of surgery, which, however, did not reach the predefined threshold. Six studies compared Disc Replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2-10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the Disc Replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85-6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference. CONCLUSION.: Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that Total Disc Replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery. © 2012, Lippincott Williams &Wilkins.
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Total Disc Replacement for chronic back pain in the presence of Disc degeneration
Cochrane Database of Systematic Reviews, 2012Co-Authors: Wilco C H Jacobs, Niels A Van Der Gaag, Alexander Tuschel, Marinus De Kleuver, Wilco C Peul, A J Verbout, Cumhur F OnerAbstract:Artificial joints have had a remarkable impact in reducing pain and improving function in the knee and hip. But what about joint Replacement in the spine? This systematic review set out to determine how Total Disc Replacement compares with other treatments for chronic low-back pain in randomised controlled trials. The Disc is a strong but flexible structure that cushions and separates the bony vertebrae of the spine. Disc degeneration is a nearly universal feature of the aging process. Though there are many theories about the causes of low-back pain, chronic symptoms are often attributed to Disc degeneration. So when patients do not improve after nonsurgical care, they sometimes consider surgery to remove a degenerated Disc. The traditional surgical approach in this area is spinal fusion, which involves removing all or part of a degenerated Disc and joining the vertebrae above and below it. Previous reviews suggest that fusion surgery can lead to moderate pain relief and modest gains in function. It appears to be superior to traditional physical therapy—but no better than an intensive rehabilitation program. An alternative surgical approach is Total Disc Replacement, which involves removing the Disc and replacing it with an artificial implant made out of metal and plastic. We identified seven randomised trials—involving a Total of 1474 patients. Only one study compared Total Disc Replacement with nonsurgical treatment, suggesting that surgery resulted in slightly better outcomes than intensive rehabilitation. But this did not translate into a clinically significant advantage that would make a major difference in patients’ lives. Six randomised trials compared Disc Replacement with spinal fusion surgery. Most of these studies had a high potential for bias, raising the possibility that they might not have provided a fair test of the treatments under study. These trials found that patients who underwent Total Disc Replacement had slightly better outcomes in terms of back pain and function than those who had fusion surgery. But again the differences did not appear clinically significant. The review could not find evidence of any other benefits of Total Disc Replacement, and the studies provided no insights on the long-term risks associated with it. Given the gaps in the evidence, the review concluded that the spine surgery community should be prudent about adopting this technology on a large scale.
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The Cochrane Library - Total Disc Replacement for chronic back pain in the presence of Disc degeneration
The Cochrane database of systematic reviews, 2012Co-Authors: Wilco C H Jacobs, Niels A Van Der Gaag, Alexander Tuschel, Marinus De Kleuver, Wilco C Peul, A J Verbout, F. Cumhur OnerAbstract:Artificial joints have had a remarkable impact in reducing pain and improving function in the knee and hip. But what about joint Replacement in the spine? This systematic review set out to determine how Total Disc Replacement compares with other treatments for chronic low-back pain in randomised controlled trials. The Disc is a strong but flexible structure that cushions and separates the bony vertebrae of the spine. Disc degeneration is a nearly universal feature of the aging process. Though there are many theories about the causes of low-back pain, chronic symptoms are often attributed to Disc degeneration. So when patients do not improve after nonsurgical care, they sometimes consider surgery to remove a degenerated Disc. The traditional surgical approach in this area is spinal fusion, which involves removing all or part of a degenerated Disc and joining the vertebrae above and below it. Previous reviews suggest that fusion surgery can lead to moderate pain relief and modest gains in function. It appears to be superior to traditional physical therapy—but no better than an intensive rehabilitation program. An alternative surgical approach is Total Disc Replacement, which involves removing the Disc and replacing it with an artificial implant made out of metal and plastic. We identified seven randomised trials—involving a Total of 1474 patients. Only one study compared Total Disc Replacement with nonsurgical treatment, suggesting that surgery resulted in slightly better outcomes than intensive rehabilitation. But this did not translate into a clinically significant advantage that would make a major difference in patients’ lives. Six randomised trials compared Disc Replacement with spinal fusion surgery. Most of these studies had a high potential for bias, raising the possibility that they might not have provided a fair test of the treatments under study. These trials found that patients who underwent Total Disc Replacement had slightly better outcomes in terms of back pain and function than those who had fusion surgery. But again the differences did not appear clinically significant. The review could not find evidence of any other benefits of Total Disc Replacement, and the studies provided no insights on the long-term risks associated with it. Given the gaps in the evidence, the review concluded that the spine surgery community should be prudent about adopting this technology on a large scale.
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Total Disc Replacement surgery for symptomatic degenerative lumbar Disc disease: a systematic review of the literature
European Spine Journal, 2010Co-Authors: Karin D. Eerenbeemt, Wilco C Peul, Raymond W. Ostelo, Barend J. Royen, Maurits W. TulderAbstract:The objective of this study is to evaluate the effectiveness and safety of Total Disc Replacement surgery compared with spinal fusion in patients with symptomatic lumbar Disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative Disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total Disc Replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the Total Disc Replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial Disc was non-inferior to the BAK^® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The ProDisc artificial Disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the Total Disc Replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.
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Total Disc Replacement surgery for symptomatic degenerative lumbar Disc disease a systematic review of the literature
European Spine Journal, 2010Co-Authors: Karin D Van Den Eerenbeemt, Wilco C Peul, Raymond W. Ostelo, Barend J Van Royen, Maurits W Van TulderAbstract:The objective of this study is to evaluate the effectiveness and safety of Total Disc Replacement surgery compared with spinal fusion in patients with symptomatic lumbar Disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative Disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total Disc Replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the Total Disc Replacement was compared with lumbar fusion techniques. The Charite trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charite artificial Disc was non-inferior to the BAK® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The ProDisc artificial Disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the Total Disc Replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charite is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.
Raymond W. Ostelo - One of the best experts on this subject based on the ideXlab platform.
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Total Disc Replacement surgery for symptomatic degenerative lumbar Disc disease: a systematic review of the literature
European Spine Journal, 2010Co-Authors: Karin D. Eerenbeemt, Wilco C Peul, Raymond W. Ostelo, Barend J. Royen, Maurits W. TulderAbstract:The objective of this study is to evaluate the effectiveness and safety of Total Disc Replacement surgery compared with spinal fusion in patients with symptomatic lumbar Disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative Disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total Disc Replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the Total Disc Replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial Disc was non-inferior to the BAK^® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The ProDisc artificial Disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the Total Disc Replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.
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Total Disc Replacement surgery for symptomatic degenerative lumbar Disc disease a systematic review of the literature
European Spine Journal, 2010Co-Authors: Karin D Van Den Eerenbeemt, Wilco C Peul, Raymond W. Ostelo, Barend J Van Royen, Maurits W Van TulderAbstract:The objective of this study is to evaluate the effectiveness and safety of Total Disc Replacement surgery compared with spinal fusion in patients with symptomatic lumbar Disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative Disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total Disc Replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the Total Disc Replacement was compared with lumbar fusion techniques. The Charite trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charite artificial Disc was non-inferior to the BAK® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The ProDisc artificial Disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the Total Disc Replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charite is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.
