The Experts below are selected from a list of 969 Experts worldwide ranked by ideXlab platform
S. H. Mehdian - One of the best experts on this subject based on the ideXlab platform.
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A PROSPECTIVE RANDOMISED TRIAL: Femoral Ring ALLOGRAFT VERSUS A TITANIUM CAGE IN CIRCUMFERENTIAL LUMBAR SPINAL FUSION
2006Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:Introduction We report the two-year clinical outcome of a prospective randomised trial compaRing Femoral Ring Allograft (FRA) to a Titanium Cage (TC) in circumferential lumbar spinal fusion. Methods 83 patients recruited to the study fulfilled strict entry requirements (> 6 months chronic discogenic low back pain, failure of conservative treatment, one or two-level discographically proven discogenic pain source). 38 patients were randomised to receive FRA, 45 patients were randomised to receive TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Patients completed questionnaires including Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and the Short-Form 36 (SF-36) pre-operatively and 6, 12 and 24 months post-operatively. Results Results were available for all 83 patients with a mean follow-up of 26.5 months (range 24–75 months). Baseline demographic data (age, sex, smoking history, number of operated levels, pre-operative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p Discussion Clinical outcome following circumferential lumbar fusion with FRA readily achieves the accepted mean clinically important differences (MCID). Fusion with TC does not achieve the MCID. The use of TC for circumferential lumbar fusion appears not to be justified.
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A prospective, randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups ( p
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a prospective randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2 year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.
Paul C. Mcafee - One of the best experts on this subject based on the ideXlab platform.
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Biomechanical comparison of iliac screws versus interbody Femoral Ring allograft on lumbosacral kinematics and sacral screw strain.
Spine, 2010Co-Authors: Bryan W. Cunningham, John C. Sefter, Seok Woo Kim, Keith H. Bridwell, Paul C. McafeeAbstract:STUDY DESIGN This study evaluates the effect of iliac screw fixation versus interbody Femoral Ring allograft (FRA) on lumbosacral kinematics and sacral screw strain in long segment instrumentations. OBJECTIVE (1) Quantify kinematic properties of 3 lumbosacral fixation techniques; (2) Evaluate sacral screw strain as instrumented levels extend cephalad; and (3) Determine whether iliac screws or FRA biomechanically protect sacral screws. SUMMARY OF BACKGROUND DATA High failure rates at the lumbosacral junction have been reported with long posterior instrumentation ending with S1 pedicle screws. Achieving lumbosacral arthrodesis remains a clinical challenge. METHODS Seven human cadavaric lumbosacral spines were biomechanically evaluated intact and in 3 instrumented conditions: pedicle screw fixation alone (pedicle screw group), pedicle screw fixation supplemented with iliac screws (iliac screw group), and pedicle screw fixation supplemented with FRA (allograft group). Each condition was tested spanning L5-S1, L4-S1, L3-S1, L2-S1, and L1-S1. Testing included pure unconstrained moments (±10 Nm) in axial rotation, flexion/extension, and lateral bending, with quantification of S1 screw strain and lumbosacral range of motion (ROM). RESULTS Testing revealed decreasing lumbosacral ROM as instrumentation extended cephalad (P 0.05) CONCLUSION.: For instrumented fusions extending above L3, sacral screws should be protected with supplemental iliac screws or FRA at L5-S1. Of the two, iliac screws appear more effective.
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in vitro biomechanical investigation of the stability and stress shielding effect of lumbar interbody fusion devices
Journal of Neurosurgery, 2000Co-Authors: Masahiro Kanayama, Bryan W. Cunningham, Charles J Haggerty, Kuniyoshi Abumi, Kiyoshi Kaneda, Paul C. McafeeAbstract:Object. Interbody fusion devices are rapidly gaining acceptance as a method of ensuRing lumbar interbody arthrodesis. Although different types of devices have been developed, the comparative reconstruction stability remains controversial. It also remains unclear how different stress-shielded environments are created within the devices. Using a calf spine model, this study was designed to compare the construct stiffness afforded by 11 differently designed lumbar interbody fusion devices and to quantify their stress-shielding effects by measuRing pressure within the devices. Methods. Sixty-six lumbar specimens obtained from calves were subjected to anterior interbody reconstruction at L4–5 by using one of the following interbody fusion devices: four different threaded fusion cages (BAK device, BAK Proximity, Ray TFC, and Danek TIBFD), five different nonthreaded fusion devices (oval and circular Harms cages, Brantigan PLIF and ALIF cages, and InFix device); two different types of allograft (Femoral Ring and ...
P J Mckenna - One of the best experts on this subject based on the ideXlab platform.
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A PROSPECTIVE RANDOMISED TRIAL: Femoral Ring ALLOGRAFT VERSUS A TITANIUM CAGE IN CIRCUMFERENTIAL LUMBAR SPINAL FUSION
2006Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:Introduction We report the two-year clinical outcome of a prospective randomised trial compaRing Femoral Ring Allograft (FRA) to a Titanium Cage (TC) in circumferential lumbar spinal fusion. Methods 83 patients recruited to the study fulfilled strict entry requirements (> 6 months chronic discogenic low back pain, failure of conservative treatment, one or two-level discographically proven discogenic pain source). 38 patients were randomised to receive FRA, 45 patients were randomised to receive TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Patients completed questionnaires including Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and the Short-Form 36 (SF-36) pre-operatively and 6, 12 and 24 months post-operatively. Results Results were available for all 83 patients with a mean follow-up of 26.5 months (range 24–75 months). Baseline demographic data (age, sex, smoking history, number of operated levels, pre-operative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p Discussion Clinical outcome following circumferential lumbar fusion with FRA readily achieves the accepted mean clinically important differences (MCID). Fusion with TC does not achieve the MCID. The use of TC for circumferential lumbar fusion appears not to be justified.
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A prospective, randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups ( p
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a prospective randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2 year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.
M P Grevitt - One of the best experts on this subject based on the ideXlab platform.
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A PROSPECTIVE RANDOMISED TRIAL: Femoral Ring ALLOGRAFT VERSUS A TITANIUM CAGE IN CIRCUMFERENTIAL LUMBAR SPINAL FUSION
2006Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:Introduction We report the two-year clinical outcome of a prospective randomised trial compaRing Femoral Ring Allograft (FRA) to a Titanium Cage (TC) in circumferential lumbar spinal fusion. Methods 83 patients recruited to the study fulfilled strict entry requirements (> 6 months chronic discogenic low back pain, failure of conservative treatment, one or two-level discographically proven discogenic pain source). 38 patients were randomised to receive FRA, 45 patients were randomised to receive TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Patients completed questionnaires including Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and the Short-Form 36 (SF-36) pre-operatively and 6, 12 and 24 months post-operatively. Results Results were available for all 83 patients with a mean follow-up of 26.5 months (range 24–75 months). Baseline demographic data (age, sex, smoking history, number of operated levels, pre-operative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p Discussion Clinical outcome following circumferential lumbar fusion with FRA readily achieves the accepted mean clinically important differences (MCID). Fusion with TC does not achieve the MCID. The use of TC for circumferential lumbar fusion appears not to be justified.
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A prospective, randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups ( p
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a prospective randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2 year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.
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A COMPARISON OF COST AND OUTCOME AT ONE YEAR BETWEEN INTRADISCAL ELECTROTHERMAL THERAPY AND FUSION OF A SINGLE LEVEL IN THE LUMBAR SPINE.
Journal of Bone and Joint Surgery-british Volume, 2005Co-Authors: P J Mckenna, J Hegarty, M P GrevittAbstract:Purpose of study. To compare the cost and outcome of Intradiscal Elecrothermal Therapy (IDET) with fusion (anterior lumbar interbody fusion with posterior translaminar screws) at one year, in single level lumbar disc disease. Methods. 49 patients were prospectively enrolled for IDET. The 49 fusion group patients had either a Syncage or Femoral Ring Allograft. All patients had at least 6 months of LBP with single level disease on MRI or positive discography. Results. The two groups were demographically similar. Pre-treatment ODI, VAS and SF-36 for physical function were significantly worse in the fusion group (p Conclusions. Fusion is substantially more expensive than IDET with comparable clinical outcome.
B. J. Freeman - One of the best experts on this subject based on the ideXlab platform.
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THE CLINICAL AND RADIOLOGICAL OUTCOME OF A PROSPECTIVE RANDOMISED CONTROLLED TRIAL OF CIRCUMFERENTIAL LUMBAR SPINAL FUSION: Femoral Ring ALLOGRAFT VERSUS TITANIUM CAGE
2008Co-Authors: B. J. Freeman, N Hussain, P Mckenna, Y H Yau, Y Leung, J Hegarty, R W KerslakeAbstract:Aim: The clinical and radiological outcomes of a prospective randomised controlled trial compaRing Femoral Ring Allografts (FRA) to Titanium Cages (TC) for circumferential fusion are presented. Methods: Eighty-three patients were recruited fulfilling strict entry requirements (>6 months chronic discogenic Low Back Pain (LBP), failure of conservative treatment, one or two level discographically-proven discogenic pain). Five patients were excluded on technical infRingements (unable to insert TC or FRA). From 78 patients randomised, 37 received FRA and 41 received TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Patients completed the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) for back and leg pain, the Short-Form 36 (SF-36) pre-operatively and 6, 12 and 24 months post-operatively. Assessment of fusion was made by a panel of 6 individuals examining radiographs taken at the same specified time points. Results: Clinical outcomes were available for all 83 patients (mean follow-up 28 months, range 24–75). Baseline demographic data showed no statistical difference between groups (p 11 points in 6 of 8 domains (p only two of eight domains. Revision procedures and complications were similar in both groups. For the FRA group, 27 levels were fused from a total of 42 assessed (64.2%). For the TC group, 33 levels were fused from a total of 55 assessed (60%). This difference was not statistically significant p>0.2. Conclusion: The use of FRA in circumferential lumbar fusion was associated with superior clinical outcomes when compared to those observed following the use of TC. Both groups had similar fusion rates.
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A PROSPECTIVE RANDOMISED TRIAL: Femoral Ring ALLOGRAFT VERSUS A TITANIUM CAGE IN CIRCUMFERENTIAL LUMBAR SPINAL FUSION
2006Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:Introduction We report the two-year clinical outcome of a prospective randomised trial compaRing Femoral Ring Allograft (FRA) to a Titanium Cage (TC) in circumferential lumbar spinal fusion. Methods 83 patients recruited to the study fulfilled strict entry requirements (> 6 months chronic discogenic low back pain, failure of conservative treatment, one or two-level discographically proven discogenic pain source). 38 patients were randomised to receive FRA, 45 patients were randomised to receive TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Patients completed questionnaires including Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and the Short-Form 36 (SF-36) pre-operatively and 6, 12 and 24 months post-operatively. Results Results were available for all 83 patients with a mean follow-up of 26.5 months (range 24–75 months). Baseline demographic data (age, sex, smoking history, number of operated levels, pre-operative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p Discussion Clinical outcome following circumferential lumbar fusion with FRA readily achieves the accepted mean clinically important differences (MCID). Fusion with TC does not achieve the MCID. The use of TC for circumferential lumbar fusion appears not to be justified.
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A prospective, randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups ( p
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a prospective randomised controlled trial of Femoral Ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2 year clinical results
European Spine Journal, 2005Co-Authors: P J Mckenna, B. J. Freeman, R.c. Mulholland, M P Grevitt, J K Webb, S. H. MehdianAbstract:The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials compaRing TCs to Femoral Ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infRingements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p 11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.
