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Clayton A. Peimer - One of the best experts on this subject based on the ideXlab platform.
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treatment of recurrent Dupuytren Contracture in joints previously effectively treated with collagenase clostridium histolyticum
Journal of Hand Surgery (European Volume), 2017Co-Authors: Brian J Bear, James P Tursi, Gregory J Kaufman, Thomas F D Kaplan, Clayton A. Peimer, Ted M SmithAbstract:Purpose Collagenase Clostridium histolyticum (CCH) is approved for the treatment of adults with Dupuytren Contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent Contractures in joints that were previously effectively treated with CCH. Methods Patients participating in a long-term follow-up study who had Contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint Contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint Contracture, range of motion, and the percentage of joints that achieved Contracture of 5° or less at day 30 after the last injection. Results The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved Contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported. Conclusions At a short-term follow-up of 1 year, recurrent Contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH. Type of study/level of evidence Therapeutic IV.
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Pain Associated With Treatment of Dupuytren Contracture With Collagenase Clostridium histolyticum
The Journal of hand surgery, 2017Co-Authors: R Sanjuan-cervero, F J Carrera-hueso, Narjis Fikri-benbrahim, Pedro Vazquez-ferreiro, Nuria Franco-ferrando, Clayton A. PeimerAbstract:Purpose The primary objective of this study was to quantify the degree of pain associated with collagenase Clostridium histolyticum (CCH) injection and to determine whether it is related to other factors in the intervention. Methods A prospective study of 135 patients was performed to evaluate pain at 3 points during treatment: (1) after CCH injection, using a numerical rating scale (NRS), (2) a binary (positive/negative) assessment before manipulation 24 hours after CCH and after removing the bandage, and (3) after joint manipulation performed with wrist block anesthesia. Results The average NRS for pain during infiltration was 4.7. Pain was present before manipulation in 52.6% of patients. Pain from manipulation showed an average NRS score of 3.6. The amounts of pain at CCH infiltration, pain after 24 hours, and pain from the manipulation were correlated because patients who experienced pain during CCH infiltration were more likely to report experiencing pain during manipulation. Conclusions Collagenase Clostridium histolyticum injection for treating Dupuytren Contracture can be a painful process. There is a clear relationship between a patient's level of pain during injection of CCH and the likelihood that the patient will experience pain during manipulation, even with the use of local anesthesia. Type of study/level of evidence Prognostic IV.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless collagenase option for reduction of Dupuytren long term evaluation of safety study 5 year data
Journal of Hand Surgery (European Volume), 2015Co-Authors: Philip E Blazar, Theodore R Smith, Thomas F D Kaplan, Clayton A. Peimer, Stephen Coleman, Tommy LindauAbstract:Purpose Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren Contracture. Methods Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for Contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° Contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening Contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment. Results Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)—39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events. Conclusions Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren Contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options. Type of study/level of evidence Therapeutic II.
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collagenase clostridium histolyticum for Dupuytren Contracture patterns of use and effectiveness in clinical practice
Journal of Hand Surgery (European Volume), 2013Co-Authors: Clayton A. Peimer, Paul Skodny, John I MackowiakAbstract:Purpose To collect data on the real-world effectiveness of collagenase clostridium histolyticum (CCH) during its first year of use following U.S. Food and Drug Administration approval and compare those results with clinical trial efficacy data. Methods This retrospective chart review was conducted at 10 U.S. community and academic practice sites with major experience using CCH. Charts of patients treated with CCH between February and December 2010 were abstracted, and anonymized data were analyzed. Clinical use, including number of injections per cord and effectiveness outcomes (joint Contracture and range of motion) were compared with results from 2 registration trials. Results Data were collected from 501 patients (74% male; 48% employed; mean [SD] age, 65 [10] y); 463 patients had sufficient data for analysis. We found that 1.08 CCH injections were used per treated joint, compared with a mean of 1.7 injections in registration trials. Ninety-three percent of joints received only 1 injection. The mean (SD) number of visits per injection was 2.92 (1.0). Mean (SD) Contracture was reduced by 75% from 49° (21) at baseline to 12° (17), similar to the 71% to 79% reduction in clinical trials. Mean (SD) range of motion was improved by 37° from 44° (20) at baseline to 81° (14), similar to the increase of 35° and 37° in the 2 clinical trials; and 67% of first injections resulted in full correction to 0° to 5°, compared with the clinical trial rate of 39%. Conclusions Despite a lower injection rate, correction of joint Contracture and range of motion was similar to findings from clinical trials. Effectiveness reports using this kind of surveillance design could provide patients, physicians, and payers with the information needed to make better treatment and reimbursement decisions. Type of study/level of evidence Therapeutic III.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless study 3 year data
Journal of Hand Surgery (European Volume), 2013Co-Authors: Clayton A. Peimer, Philip E Blazar, Theodore R Smith, James P Tursi, Gregory J Kaufman, Thomas F D Kaplan, Stephen Coleman, Brian Cohen, Tommy LindauAbstract:Purpose To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study. Methods This study enrolled Dupuytren Contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint Contracture and safety. Recurrence in a previously successfully treated joint (success = 0° to 5° Contracture after CCH administration) was defined as 20° or greater worsening in Contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening Contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline Contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of Contracture or medical/surgical intervention. Results Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n=643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° Contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 149]) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection. Conclusions The recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren Contracture. Most successfully treated joints had a Contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints. Type of study/level of evidence Therapeutic IV.
Jeppe Lange - One of the best experts on this subject based on the ideXlab platform.
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percutaneous needle fasciotomy in Dupuytren Contracture a register based observational cohort study on complications in 3 331 treated fingers in 2 257 patients
Acta Orthopaedica, 2020Co-Authors: Laura Houstrup Therkelsen, Simon Toftgaard Skov, Malene Laursen, Jeppe LangeAbstract:Background and purpose - Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren Contracture, which has gained momentum worldwide in recent years. However, evidence regarding safety and severe complications associated with PNF is sparse. Thus, we evaluated safety of a specific PNF method in the largest cohort reported in literature.Patients and methods - This is a single-center, register-based, observational study on PNF treatments between 2007 and 2015. The study cohort was identified by the Danish National Patient Registry, and diagnosis codes and procedure codes were used to identify potential severe postoperative complications such as: tendon rupture, nerve damage, infection, amputation, and reflex dystrophy for all index treatments. The Danish National Prescription Registry was used to identify non-hospital-treated infections. All index treatments and postoperative complications were verified by review of medical records.Results - 2,257 patients received PNF treatment of 3,331 treated finger rays. Median follow-up was 7.2 years (interquartile range: 4.9-9.5 years, range 1-12 years). 4 patients sustained flexor tendon rupture. 1 patient had digital nerve damage. 2 patients had an infection treated in hospital, while 31 patients received antibiotics in the primary sector for an infection or based on suspicion of an infection after PNF. None of the infections required surgical intervention. No finger amputations or ipsilateral upper limb reflex dystrophy cases were registered in relation to the procedure.Interpretation - Percutaneous needle fasciotomy for Dupuytren Contracture is a safe procedure with a low rate of severe postoperative complications when a specific PNF method is applied.
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percutaneous needle fasciotomy in Dupuytren Contracture a register based observational cohort study on complications in 3 331 treated fingers in 2 257 patients
Acta Orthopaedica, 2020Co-Authors: Laura Houstrup Therkelsen, Simon Toftgaard Skov, Malene Laursen, Jeppe LangeAbstract:Background and purpose — Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren Contracture, which has gained momentum worldwide in recent years. However, evide...
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injectable collagenase versus percutaneous needle fasciotomy for Dupuytren Contracture in proximal interphalangeal joints a randomized controlled trial
Journal of Hand Surgery (European Volume), 2017Co-Authors: Simon Toftgaard Skov, Therkel Bisgaard, Per Sondergaard, Jeppe LangeAbstract:Purpose Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren Contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren Contracture with more than 1-year follow-up, despite a wide and increasing clinical use. Method In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren Contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in Contracture by 50% or more relative to baseline. Secondary outcomes included change in Contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. Results Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. Conclusions This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren Contracture regarding clinical outcome, and it led to more complications than PNF. Type of study/level of evidence Therapeutic I.
Philip E Blazar - One of the best experts on this subject based on the ideXlab platform.
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limited fasciectomy versus collagenase clostridium histolyticum for Dupuytren Contracture a propensity score matched study of single digit treatment with minimum 5 years of telephone follow up
Journal of Hand Surgery (European Volume), 2021Co-Authors: Jillian S Gruber, Philip E Blazar, Dafang Zhang, Stein J Janssen, Jesse B Jupiter, Brandon E EarpAbstract:Purpose The purpose of this study was to compare reintervention and perceived recurrence, with minimum 5 years of telephone follow-up, after limited fasciectomy or collagenase Clostridium histolyticum (CCH) in the treatment of Dupuytren Contracture affecting a single digit. Methods We performed a retrospective cohort study of 48 patients with single digit treatment who underwent limited surgical fasciectomy at one hospital and 111 patients who underwent CCH treatment at a second hospital from 2010 to 2013. Patients were contacted by telephone about reintervention and perceived recurrence. Average length of telephone follow-up was 7.3 years in the CCH group and 7.4 years in the surgery group. The 2 groups were compared using 2 methods to control for potential confounding bias: (1) propensity score matching and (2) multivariable analysis accounting for potential confounders. Results After propensity score matching, there were 44 patients in each group with similar disease and demographic characteristics. Rates of reintervention and perceived recurrence were significantly higher in the CCH group than the surgery group at a minimum of 5 years following treatment. Conclusions Long-term overall reintervention and perceived recurrence following treatment of Dupuytren Contracture affecting a single digit were higher with CCH treatment than surgical fasciectomy when comparing groups with similar baseline characteristics. Our findings may be used to counsel patients on the durability of the outcomes of treatment when considering treatment options for Dupuytren Contractures. Type of study/level of evidence Therapeutic IV.
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The Impact of Collagenase Clostridium histolyticum Introduction on Dupuytren Treatment Patterns in the United States
The Journal of hand surgery, 2016Co-Authors: John Z. Zhao, Brandon E Earp, Scott R. Hadley, Emerson Floyd, Philip E BlazarAbstract:Purpose The U.S. Food and Drug Administration approved the use of collagenase Clostridium histolyticum (CCH) in the United States in February 2010. This study addresses the impact of that approval on the number of Dupuytren Contracture (DC) encounters and treatment patterns in the United States. Methods Using the Intercontinental Marketing Services Health Office-Based Medical Claims database, we identified the monthly number of DC encounters and DC procedures between January 2007 and December 2013. Collagenase Clostridium histolyticum usage data from March 2010 to December 2013 was derived from the U.S. CCH manufacturer's data warehouse. Using the combined data, the yearly increasing trends in DC encounters and treatment volume were compared before and after the introduction of CCH. Time trends in the relative procedure frequencies were then examined. Finally, the presence of seasonal variation was tested for in each treatment type. Results Dupuytren Contracture encounters increased on average by 19,015 per year between 2007 and 2009, whereas between 2011 and 2013, DC encounters increased on average by 34,940 per year. In terms of absolute procedure counts, the surgery trend line began decreasing in 2010 with the release of CCH. Meanwhile, CCH continuously increased between 2010 and 2013, and needle aponeurotomy (NA) remained relatively stable. By the year 2013, minimally invasive techniques (NA and CCH) comprised 39% of all treatment, compared with only 14% in 2007. Lastly, there was a statistically significant seasonal increase in the number of surgical procedures during the wintertime but no seasonal variation in NA or CCH. Conclusions After the introduction of CCH, the number of Dupuytren encounters increased at a greater annual rate. The introduction and growth of CCH coincided with a decrease in surgery. The number of NA procedures remained steady throughout the study period. The number of open surgery cases followed a predictable seasonal variation with more procedures during the winter months, but this seasonal variation was not seen with less invasive techniques. Type of study/level of evidence Economic/Decision Analysis II.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless collagenase option for reduction of Dupuytren long term evaluation of safety study 5 year data
Journal of Hand Surgery (European Volume), 2015Co-Authors: Philip E Blazar, Theodore R Smith, Thomas F D Kaplan, Clayton A. Peimer, Stephen Coleman, Tommy LindauAbstract:Purpose Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren Contracture. Methods Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for Contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° Contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening Contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment. Results Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)—39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events. Conclusions Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren Contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options. Type of study/level of evidence Therapeutic II.
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arthrodesis of the thumb interphalangeal joint and finger distal interphalangeal joints with a headless compression screw
Journal of Hand Surgery (European Volume), 2014Co-Authors: Brandon E Earp, Emerson W Floyd, Philip E BlazarAbstract:PURPOSE: To study the results of using a small, headless compression screw (AcuTwist) for thumb interphalangeal (IP) joint and finger distal interphalangeal (DIP) joint arthrodeses. METHODS: Between November 2007 and January 2012, 48 primary arthrodeses of the thumb IP joint or DIP joint in the other digits were performed in 29 consecutive patients with AcuTwist devices. Indications for arthrodesis included 19 cases of osteoarthritis in 25 fingers, 3 cases of lupus in 9 fingers, 2 cases of post-traumatic osteoarthritis in 2 fingers, and 1 case and finger each of acute trauma, neuromuscular disorder, postinfectious osteoarthritis, boutonniere deformity, and Dupuytren Contracture. Charts were reviewed for clinical data, and radiographs were assessed for alignment and healing. RESULTS: Age averaged 59 years and follow-up averaged 12 months (range, 2-50 mo). Union occurred in 43 out of 46 fingers (94%). There were no cases of nail deformity, wound complications, tip hypersensitivity, or clinically notable malalignment. Three arthrodeses failed to fuse, including 2 asymptomatic nonunions and 1 fixation loss requiring revision with autograft. The complication rate was 9%. CONCLUSIONS: Distal digital joint arthrodesis with the AcuTwist resulted in a fusion rate of 94% with a complication rate of 9%. Our rate of fusion compares favorably with prior series using other methods of fixation. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless study 3 year data
Journal of Hand Surgery (European Volume), 2013Co-Authors: Clayton A. Peimer, Philip E Blazar, Theodore R Smith, James P Tursi, Gregory J Kaufman, Thomas F D Kaplan, Stephen Coleman, Brian Cohen, Tommy LindauAbstract:Purpose To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study. Methods This study enrolled Dupuytren Contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint Contracture and safety. Recurrence in a previously successfully treated joint (success = 0° to 5° Contracture after CCH administration) was defined as 20° or greater worsening in Contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening Contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline Contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of Contracture or medical/surgical intervention. Results Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n=643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° Contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 149]) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection. Conclusions The recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren Contracture. Most successfully treated joints had a Contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints. Type of study/level of evidence Therapeutic IV.
Simon Toftgaard Skov - One of the best experts on this subject based on the ideXlab platform.
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percutaneous needle fasciotomy in Dupuytren Contracture a register based observational cohort study on complications in 3 331 treated fingers in 2 257 patients
Acta Orthopaedica, 2020Co-Authors: Laura Houstrup Therkelsen, Simon Toftgaard Skov, Malene Laursen, Jeppe LangeAbstract:Background and purpose - Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren Contracture, which has gained momentum worldwide in recent years. However, evidence regarding safety and severe complications associated with PNF is sparse. Thus, we evaluated safety of a specific PNF method in the largest cohort reported in literature.Patients and methods - This is a single-center, register-based, observational study on PNF treatments between 2007 and 2015. The study cohort was identified by the Danish National Patient Registry, and diagnosis codes and procedure codes were used to identify potential severe postoperative complications such as: tendon rupture, nerve damage, infection, amputation, and reflex dystrophy for all index treatments. The Danish National Prescription Registry was used to identify non-hospital-treated infections. All index treatments and postoperative complications were verified by review of medical records.Results - 2,257 patients received PNF treatment of 3,331 treated finger rays. Median follow-up was 7.2 years (interquartile range: 4.9-9.5 years, range 1-12 years). 4 patients sustained flexor tendon rupture. 1 patient had digital nerve damage. 2 patients had an infection treated in hospital, while 31 patients received antibiotics in the primary sector for an infection or based on suspicion of an infection after PNF. None of the infections required surgical intervention. No finger amputations or ipsilateral upper limb reflex dystrophy cases were registered in relation to the procedure.Interpretation - Percutaneous needle fasciotomy for Dupuytren Contracture is a safe procedure with a low rate of severe postoperative complications when a specific PNF method is applied.
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percutaneous needle fasciotomy in Dupuytren Contracture a register based observational cohort study on complications in 3 331 treated fingers in 2 257 patients
Acta Orthopaedica, 2020Co-Authors: Laura Houstrup Therkelsen, Simon Toftgaard Skov, Malene Laursen, Jeppe LangeAbstract:Background and purpose — Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren Contracture, which has gained momentum worldwide in recent years. However, evide...
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injectable collagenase versus percutaneous needle fasciotomy for Dupuytren Contracture in proximal interphalangeal joints a randomized controlled trial
Journal of Hand Surgery (European Volume), 2017Co-Authors: Simon Toftgaard Skov, Therkel Bisgaard, Per Sondergaard, Jeppe LangeAbstract:Purpose Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren Contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren Contracture with more than 1-year follow-up, despite a wide and increasing clinical use. Method In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren Contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in Contracture by 50% or more relative to baseline. Secondary outcomes included change in Contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. Results Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. Conclusions This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren Contracture regarding clinical outcome, and it led to more complications than PNF. Type of study/level of evidence Therapeutic I.
Tommy Lindau - One of the best experts on this subject based on the ideXlab platform.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless collagenase option for reduction of Dupuytren long term evaluation of safety study 5 year data
Journal of Hand Surgery (European Volume), 2015Co-Authors: Philip E Blazar, Theodore R Smith, Thomas F D Kaplan, Clayton A. Peimer, Stephen Coleman, Tommy LindauAbstract:Purpose Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren Contracture. Methods Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for Contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° Contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening Contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment. Results Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)—39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events. Conclusions Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren Contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options. Type of study/level of evidence Therapeutic II.
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efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren Contracture short term results from 2 open label studies
Journal of Hand Surgery (European Volume), 2013Co-Authors: Jörg Witthaut, Anthony Houston, Graeme Jones, Nebojsa Skrepnik, Harvey Kushner, Tommy LindauAbstract:Purpose The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren Contracture. Methods Both studies used identical open-label protocols. Patients with fixed-flexion Contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in Contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline Contracture. Results Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in Contracture was 55° for MCP joints and 25° for PIP joints. With average Contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. Conclusions Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren Contracture of a broad range of severities. Most treated joints (625 of 879) required a single injection. Treatment earlier in the course of disease provided improved outcomes. Type of study/level of evidence Therapeutic IV.
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Dupuytren Contracture recurrence following treatment with collagenase clostridium histolyticum cordless study 3 year data
Journal of Hand Surgery (European Volume), 2013Co-Authors: Clayton A. Peimer, Philip E Blazar, Theodore R Smith, James P Tursi, Gregory J Kaufman, Thomas F D Kaplan, Stephen Coleman, Brian Cohen, Tommy LindauAbstract:Purpose To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study. Methods This study enrolled Dupuytren Contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint Contracture and safety. Recurrence in a previously successfully treated joint (success = 0° to 5° Contracture after CCH administration) was defined as 20° or greater worsening in Contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening Contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline Contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of Contracture or medical/surgical intervention. Results Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n=643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° Contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 149]) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection. Conclusions The recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren Contracture. Most successfully treated joints had a Contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints. Type of study/level of evidence Therapeutic IV.
