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Purpose: Injectable collagenase Clostridium histolyticum has been an effective and well-tolerated nonsurgical treatment option for the management of Dupuytren contracture of the hand. The purpose of this study was to determine the efficacy of collagenase injection and adverse event rate in patients who had undergone previous collagenase treatment., Methods: A retrospective chart review was performed on 332 patients treated with collagenase injection for Dupuytren contracture by three fellowship-trained hand surgeons at a single institution from 2009 to 2019. Fifty-nine joints in 45 patients underwent repeat collagenase therapy for recurrent contracture in the same digit. Pretreatment and posttreatment total metacarpophalangeal and proximal interphalangeal joint flexion contractures were recorded, with complete correction defined as <5° residual digital flexion contracture. Postmanipulation skin tears and adverse events were recorded. A comparison was made between average contracture improvement after initial collagenase injection and that after repeat injection., Results: Forty-five patients with an average duration of 30 months (range, 6-73 months) between initial and repeat collagenase therapies were identified. The mean improvement after first collagenase injection was 45° ± 24° (39° for metacarpophalangeal joint and 50° for proximal interphalangeal joint) compared with a mean improvement of 43° ± 23° (41° for metacarpophalangeal joint and 44° for proximal interphalangeal joint) after second injection. Although similar complete correction rates and skin tear rates (32.2 % for initial and 30.5% for repeat) were observed between initial (80%) and repeat injections (73%), the occurrence of adverse events was 3 times higher (3.4% for initial and 10.2% for repeat) in the latter group., Conclusions: Collagenase treatment of Dupuytren contracture yields effective total flexion contracture correction. Repeat collagenase treatment of previously treated digits yields similar deformity correction and complete correction rates but a higher incidence of adverse events., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2024 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: The objective of this systematic review and meta-analysis was to synthesize the available randomized controlled trial data comparing needle fasciotomy and collagenase treatment for single-digit Dupuytren contractures with a minimum of 3-year follow-up and determine whether one treatment is superior regarding contracture correction and functional outcomes., Methods: A systematic review and meta-analysis was conducted by searching four databases for randomized controlled trials investigating the single-digit treatment outcomes for Dupuytren contracture comparing collagenase treatment and needle fasciotomy with a minimum of 3-year follow-up. The risk of bias of included studies was assessed using the Cochrane risk-of-bias tool. A meta-analysis was performed using a random effects model in anticipation of unobserved heterogeneity. The primary outcome measure was contracture recurrence. Secondary outcome measures included final fixed flexion contracture (FFC), Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores, and Unité Rhumatologique des Affections de la Main (URAM) scores., Results: After screening 264 articles, 4 randomized clinical trials were eligible for final inclusion. One trial had a high risk of bias, and two trials had some concern for bias. The final meta-analysis included 347 patients, 169 who underwent collagenase treatment and 178 who underwent needle fasciotomy. No significant differences were noted between the groups in contracture recurrence, FFC, and URAM scores. The pooled data showed a higher QuickDASH score in the collagenase treatment group compared with the needle fasciotomy group, but the observed difference was less than what would be expected to be clinically relevant., Conclusions: Needle fasciotomy and collagenase treatment have similar outcomes with regards to contracture recurrence, final FFC, QuickDASH scores, and URAM scores for the single-digit treatment for Dupuytren contracture at a minimum of 3-year follow-up. Relevant factors that may be considered during the shared decision-making process for treatment selection include surgeon and patient preferences, costs of treatment, and the disparate complication profiles of these two treatments., Type of Study/level of Evidence: Therapeutic II., (Copyright © 2023 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Dupuytren disease is a benign, progressive fibroproliferative disorder of the hands. To date, only one pharmacotherapy (clostridial collagenase) has been approved for use in Dupuytren disease. There is a great need for additional nonsurgical methods that can be used to either avoid the risks of invasive treatments or help minimize recurrence rates following treatment. A number of nonsurgical modalities have been discussed in the past and continue to appear in discussions among hand surgeons, despite highly variable and often poor or no long-term clinical data. This article reviews many of the pharmacotherapies discussed in the treatment of Dupuytren disease and novel therapies used in inflammation and fibrosis that offer potential treatment options., (Copyright © 2023. Published by Elsevier Inc.)

Purpose: To compare collagenase injection with surgical fasciectomy in Dupuytren disease (DD) for the prevalence of contracture in treated fingers 5 years after treatment., Methods: This was a single-center, comparative cohort study comprising 2 cohorts of patients treated for DD in 1 or more of 3 ulnar fingers with collagenase injection (159 patients) or surgical fasciectomy (59 patients). At 5 years after treatment, 13 collagenase-treated and 8 fasciectomy-treated patients had undergone subsequent treatment on the treated fingers and were considered to have current contracture. Of the remaining patients, 112 collagenase-treated patients (128 hands, 180 fingers) and 46 fasciectomy-treated patients (49 hands, 63 fingers) attended follow-up evaluation performed by 2 independent examiners (participation rate 84% and 93%, respectively). We defined current contracture in a treated finger as an active extension deficit of ≥20° in the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint or a total (MCP + PIP) active extension deficit (TAED) of ≥30°. We used linear mixed models to analyze differences between the cohorts over time., Results: In the collagenase cohort, current contracture was present in 45 (25%) MCP and 60 (33%) PIP joints, and in the fasciectomy cohort, current contracture was present in 12 MCP (19%) and 30 PIP (48%) joints; a TAED of ≥30° was present in 79 (44%) of the collagenase-treated and 30 (48%) of the fasciectomy-treated fingers. In MCP and PIP joints with ≥20° pretreatment contracture, complete correction was observed in 82 (56%) MCP and 30 (30%) PIP joints in the collagenase cohort and 23 (70%) MCP and 5 (16%) PIP joints in the fasciectomy cohort. There was no statistically significant difference between the 2 cohorts in the TAED change over time., Conclusions: In patients with DD, collagenase injection and surgical fasciectomy improved finger joint contracture over the pretreatment status but had a high prevalence of joint contracture in the treated fingers 5 years after treatment., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2022. Published by Elsevier Inc.)

Purpose: Over the past decade, collagenase treatment and needle fasciotomy (NF) have gained widespread popularity in the treatment of Dupuytren contracture. This prospective study was designed to compare the results of these treatments in terms of clinical and patient-reported outcomes., Methods: A prospective, randomized, controlled trial included patients with a contracture of 20° or more in a single metacarpophalangeal joint. Patients were allocated to treatment with either NF or collagenase Clostridium histolyticum. The primary outcome was a reduction in the metacarpophalangeal joint contracture to less than 5°. Secondary outcomes included recurrence, the presence of Dupuytren cords, and changes in patient-reported outcomes. The participants were examined 5 years after the intervention., Results: The study cohort comprised 156 patients divided into 2 equally sized groups. After 5 years, data were collected from 143 (92 %) of the initially enrolled participants. The mean time for the clinical follow-up was 5.1 years. In the remaining cohort without a second procedure, 51% (23 patients) in the collagenase Clostridium histolyticum group and 47% (27 patients) in the NF group still had extension deficits of less than 5°. Among the participants with a successful initial procedure, the recurrence rate was 56% (36 patients) in the collagenase Clostridium histolyticum group and 45% (30 patients) in the NF group. There were no differences between the 2 treatments in regard to passive joint extension, reduction of contracture, range of motion, or patient-reported outcomes., Conclusions: The 5-year outcomes for NF are similar to those for collagenase in terms of sustained correction, recurrence, presence of Dupuytren cords, and patient-reported outcomes for the treatment of metacarpophalangeal joint contractures., Type of Study/level of Evidence: Therapeutic I., (Copyright © 2022 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Dupuytren disease is a fibroproliferative disorder that affects the palmar fascia of the hand and results in varying degrees of nodule and cord formation. Over time, patients may develop progressive contractures, impairing their ability to type, to perform with fine instruments, or to participate in social activities such as shaking hands. Treatment options for Dupuytren contractures include needle aponeurotomy (NA), injection of collagenase Clostridium histolyticum (CCH) with manipulation of the digits, and surgical fasciectomy. Over the past decade, the use of CCH has increased. Recent studies have provided additional data regarding the pathophysiology, indications, outcomes, and costs associated with the treatment for Dupuytren contractures, and this review highlights these advances., (Copyright © 2021 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: We offer collagenase Clostridium histolyticum (CCH) injections to all patients with a Dupuytren contracture and a palpable cord. We assessed whether more severe contractures respond less well or recur more frequently., Methods: From a database of 502 CCH injections, 386 (77%) had a complete dataset with minimum 1-year face-to-face follow-up. Contracture severity was assessed using the Tubiana system: grade 1 (27%), grade 2 (49%), grade 3 (19%), and grade 4 (5%). Patients received a single intralesional injection of 0.58 mg CCH followed by manipulation. Finger position was measured at 6 to 12 weeks, 6 months, and 1 year. Failure to break the cord, skin tears, and any adverse events were noted. Recurrence was defined as a failure to maintain any prior correction to within 20°., Results: There were 17 failures (4%) and 6 allergic reactions (1%). We found 31% corrected completely, with approximately half remaining corrected at 1 year. We achieved 43° (95% confidence interval, 40°-46°) correction of combined deformity, with 11° (95% confidence interval, 9°-13°) correction attrition over 1 year. Sixteen percent of treated digits experienced a recurrence with no difference between Tubiana grades, and one-third chose further treatment. Following treatment, Tubiana grade 1 contractures improved by 78% in comparison with higher grade contractures (55%-67% relative correction). By 1 year, all grades had a similar mean 46% relative correction. A complete correction was seen in 61% of grade 1 contractures, with more severe contractures less likely to correct completely (9%-24%). A 31% skin tear rate had no impact on outcome, recurrence, or long-term morbidity., Conclusions: CCH may treat any Dupuytren cord regardless of severity. Although contracture may recur, few patients pursue further treatment within 1 year., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2020 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to analyze the durability of the treatment results of the thumb and first web contractures in Dupuytren disease with collagenase Clostridium histolyticum., Methods: Twelve patients (14 hands) were followed for an average of 35 months (range, 24-42 months). Two patients (3 hands) were excluded, yielding 11 hands available for assessment. Nondurability was defined as a worsening of at least 20° of passive extension deficit at a treated joint or any decrease greater than 5 mm in intermetacarpal head distance, both relative to 30 days after injection or as intervention to correct new/worsening contracture. Durability was compared with that of a historic cohort of treated finger contractures., Results: Five out of 11 patients with a metacarpophalangeal or interphalangeal joint contracture or first web contracture had a nondurable result at an average of 35 months. Results obtained at metacarpophalangeal joints of thumbs were more durable than those of interphalangeal joints. Most of the recurrences occurred in interphalangeal joints., Conclusions: Treatment of thumb and first web contractures was not durable in nearly half of the cases at an average follow-up of 35 months, and durability was clearly less than that of treated finger contractures., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2019 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: To explore the efficacy of injectable collagenase Clostridium histolyticum (CCH) in distal interphalangeal (DIP) joint contractures in Dupuytren disease., Methods: A retrospective review was conducted for patients with DIP joint contractures treated with CCH. Baseline contracture and posttreatment residual contracture were recorded. The primary end point was achievement of 0° to 5° of residual contracture 30 days postmanipulation. Recurrence and adverse events are also reported., Results: Twenty-one patients were treated with collagenase for DIP joint contractures and had a mean follow-up of 2.6 months. Seventeen of 21 patients reached the primary end point of less than 5° residual flexion contracture. Eleven of 21 patients experienced an adverse event, most commonly bruising and edema. No serious complications such as neurovascular injuries or tendon ruptures were recorded. Two patients had recurrence of disease., Conclusions: Injection with CCH is an option for the treatment of DIP joint contractures in Dupuytren disease., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2019 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: Standard 0.58 mg (0.25 mL) collagenase Clostridium histolyticum (CCH) preparations result in unused CCH that is often discarded. Our purpose was to assess the results on Dupuytren contractures affecting both the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints in the same digit utilizing an injection containing the maximum CCH volume that can be withdrawn from a single vial., Methods: A consecutive series of patients with MCP and PIP cords in the same digit received a single treatment with 2 injections totaling 0.30 mL distributed between the MCP and the PIP cords and underwent manipulation approximately 24 hours later. Reduction in contracture, clinical success, and complications were assessed 30 days after manipulation., Results: Thirty-one patients (34 digits) had a mean preinjection flexion contracture of 50° at the MCP joint and 53° at the PIP joint. Clinical success (reduction in joint contracture to 0°-5° of full extension 30-days postmanipulation) was noted in 65% of MCP cords and 38% of PIP joint cords. We had a 24% incidence of skin tears, which correlated with the degree of preinjection contracture., Conclusions: For Dupuytren contractures involving the MCP and PIP joints in the same digit, distributing the maximum amount of CCH that can be withdrawn from a single vial provides efficacy at both joints that is similar to that reported in previously published series, with a comparable complication rate. Utilizing excess CCH typically discarded may provide cost savings., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the short-term effectiveness of collagenase Clostridium histolyticum to treat thumb and first web contractures in Dupuytren disease., Methods: We prospectively included 14 thumbs in 12 patients with a contracture at the metacarpophalangeal or interphalangeal joint of at least 20° with a palpable cord in the thumb (n = 8) or an adduction contracture of the thumb with palpable cords in the first web (n = 6). They received an injection containing 0.58 mg of collagenase Clostridium histolyticum in the fibrous cord divided over 3 spots. The contracture was released by carefully manipulating the thumb under local anesthesia 1 day later. The extension and abduction deficits were measured before and after the intervention (follow-up at 7 and 30 days and 6 months). Wilcoxon signed rank test was used to analyze the data., Results: In the total sample, postintervention extension deficits were statistically significantly lower than preintervention deficits except in one patient who had a recurrence at 6 months compared with the 30-day posttreatment result. Intermetacarpophalangeal head distance (IMD) also improved significantly. In an analysis of subgroups, we compared the separate contributions of treatment of a pretendinous cord and a first web cord on both extension deficit and IMD. Treatment of pretendinous cords significantly affected both extension deficit and IMD. However, treatment of first web contractures did not significantly improve extension or IMD., Conclusions: Collagenase Clostridium histolyticum is a good treatment option for pretendinous cords in thumbs affected with Dupuytren disease because it provides good results, is minimally invasive, and has minor adverse events., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: To examine the results of proximal interphalangeal (PIP) joint contractures from 4 phase 3 clinical trials of collagenase clostridium histolyticum (CCH) injection for Dupuytren contracture., Methods: Patients enrolled in Collagenase Option for Reduction of Dupuytren I/II and JOINT I/II with one or more PIP joint contractures (20° to 80°) received CCH 0.58 mg/0.20 mL or placebo (Collagenase Option for Reduction of Dupuytren I/II only) injected directly into a palpable cord. The percentage of PIP joints achieving clinical success (0° to 5° of full extension), clinical improvement (50% or more reduction in baseline contracture), and range of motion improvement at 30 days after the first and last CCH injections was assessed. The PIP joint contractures were classified into low (40° or less) and high (more than 40°) baseline severity. Adverse events were recorded., Results: A total of 506 adults (mean age, 63 ± 10 y; 80% male) received 1,165 CCH injections in 644 PIP joint cords (mean, 1.6 injections/cord). Most patients (60%) received 1 injection, with 24%, 16%, and 1% receiving 2, 3, and 4 injections, respectively. Clinical success and clinical improvement occurred in 27% and 49% of PIP joints after one injection and in 34% and 58% after the last injection. Patients with lower baseline severity showed greater improvement and response was comparable between fingers, as were improvements in range of motion. Adverse events occurring in more than 10% of patients were peripheral edema (58%), contusion (38%), injection site hemorrhage (23%), injection site pain (21%), injection site swelling (16%), and tenderness (13%). This incidence was consistent with data reported in phase 3 trials. Two tendon ruptures occurred. No further ruptures occurred after a modified injection technique was adopted., Conclusions: Collagenase clostridium histolyticum was effective and well tolerated in the short term in patients with Dupuytren PIP joint contractures., Type of Study/level of Evidence: Therapeutic II., (Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare percutaneous needle fasciotomy (PNF) with collagenase injection in the treatment of Dupuytren contracture., Methods: A retrospective review was performed for patients with Dupuytren disease treated with PNF or collagenase. Range of motion, patient satisfaction, and complications were recorded., Results: There were 29 patients in the collagenase group with mean baseline contractures of 40° for 22 affected metacarpophalangeal joints and 50° for 12 affected proximal interphalangeal joints. The PNF group was composed of 30 patients with mean baseline contractures of 37° for 32 affected metacarpophalangeal joints and 41° for 18 affected proximal interphalangeal joints. All patients were observed for a minimum of 3 months. Clinical success (reduction of contracture within 0° to 5° of normal) was accomplished in 35 of 50 joints (67%) in the PNF group and in 19 of 34 joints (56%) in the collagenase group. Patient satisfaction was similar between groups. Only minor complications were observed, including skin tears, ecchymosis, edema, pruritus, and lymphadenopathy., Conclusions: In the short term, both PNF and collagenase have similar clinical outcomes and patient satisfaction., Type of Study/level of Evidence: Therapeutic III., (Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

The treatment of progressive Dupuytren contractures has historically been and continues to be largely surgical. Although a number of surgical interventions do exist, limited palmar fasciectomy continues to be the most common and widely accepted treatment option. Until recently, nonsurgical options were limited and clinically ineffective. However, the commercial availability and recent approval of collagenase clostridium histolyticum now provides practitioners with a nonsurgical approach to this disease. This article presents a comprehensive review of the surgical and nonsurgical treatments of Dupuytren disease, with a focus on collagenase., (Copyright © 2011 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Purpose: The Collagenase Option for the Reduction of Dupuytren's (CORD) II study investigated the efficacy and safety of injectable Xiaflex (collagenase clostridium histolyticum), in patients with Dupuytren's contracture., Methods: This was a prospective, randomized, placebo-controlled trial with 90-day double-blind and 9-month open-label phases. We randomized patients with contractures affecting metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints 2 to 1 to collagenase (0.58 mg) or placebo. Cords received a maximum of 3 injections. Cord disruption was attempted the day after injection using a standardized finger extension procedure. Primary end point was reduction in contracture to 0° to 5° of normal 30 days after the last injection., Results: We enrolled 66 patients; 45 cords (20 MCP to 25 PIP joints) received collagenase and 21 cords (11 MCP to 10 PIP joints) received placebo in the double-blind phase. Statistically significantly more cords injected with collagenase than placebo met the primary end point (44.4% vs 4.8%; p <. 001). The mean percentage decrease in degree of joint contracture from baseline to 30 days after last injection was 70.5% ± 29.2% in the collagenase group and 13.6% ± 26.1% in the placebo group (p < .001). The mean increase in range of motion was significantly greater in the collagenase (35.4° ± 17.8°) than in the placebo (7.6° ± 14.9°; p < .001) group. Efficacy after open-label treatment was similar to that after the double-blind phase: 50.7% of all joints achieved 0° to 5° of normal. More patients were satisfied with collagenase (p < .001). No joint had recurrence of contracture. One patient had a flexion pulley rupture and one patient underwent routine fasciectomy to address cord proliferation and sensory abnormality. No tendon ruptures or systemic allergic reactions were reported. Most adverse events were related to the injection or finger extension procedure., Conclusions: Collagenase clostridium histolyticum is the first Food and Drug Administration-approved, nonsurgical treatment option for adult Dupuytren's contracture patients with a palpable cord that is highly effective and well tolerated., Type of Study/level of Evidence: Therapeutic I., (Copyright © 2010. Published by Elsevier Inc.)

Surgical fasciectomy is the currently accepted treatment of Dupuytren's disease. The goal of this study was to test the clinical safety and efficacy of clostridial collagenase injection as a nonsurgical treatment of Dupuytren's disease in a phase II open-label trial. Thirty-five Dupuytren's disease patients entered the study (32 men and 3 women). The mean age was 65 years. The first 6 patients were treated following a dose escalation protocol and received 300, 600, 1,200, 2,400, 4,800, and 9,600 U collagenase injected into the cord that was causing contracture of the metacarpophalangeal (MCP) joint. There were no beneficial clinical effects of these injections. The remaining 29 patients had collagenase injections at a dose level of 10,000 U, causing contractures of 34 MCP joints, 9 proximal interphalangeal (PIP) joints, and 1 thumb. Twenty-eight of the 34 MCP joint contractures corrected to normal extension (0 degrees ) and 2 of the 34 MCP joint contractures corrected to 5 degrees of normal extension, with full range of motion, within 1 to 14 days of injection. In the patients with PIP joint contractures, 4 of the 9 joints corrected to normal (0 degrees ). One PIP joint corrected to within 10 degrees of normal and 2 corrected to within 15 degrees of normal. There were 2 failures; these patients will require surgery. The mean follow-up period was 20.0 +/- 5.6 months for the MCP joints and 14.1 +/- 6.6 months for the PIP joints. Clostridial collagenase injection of Dupuytren's cords causing MCP and PIP joint contractures appears to have merit as nonsurgical treatment of this disorder. Pending further placebo, double-blind studies, collagenase injection to treat Dupuytren's disease may be a safe and effective alternative to surgical fasciectomy.