Dupuytren Contracture Recurrence Following Treatment with Collagenase Clostridium Histolyticum (CORDLESS Study): 3-Year Data

Peimer, Clayton A.; Blazar, Philip E.; Coleman, Stephen; Kaplan, F. Thomas D.; Smith, Ted; Tursi, James P.; Cohen, Brian M.; Kaufman, Gregory J.; Lindau, Tommy

doi:10.1016/j.jhsa.2012.09.028

Cited by 151 publications

(161 citation statements)

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“…Most patients in Study 3 received three injections of CCH. This is consistent with studies of CCH for Dupuytren's contracture [1,5,10] and in clinical trials of CCH for Peyronie's disease using multiple injections [3]. Compared with other clinical studies of conservative treatment of adhesive capsulitis [2,6,8,9,11], CCH injections in Study 3 allowed patients to achieve improved ROM, functional status, and pain relief in a shorter time.…”

Section: Discussionsupporting

confidence: 82%

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

Badalamente

Wang

2016

Clinical Orthopaedics &Amp; Related Research

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Background Conservative and even surgical management of adhesive capsulitis often is prolonged and painful. Management of adhesive capsulitis is lacking evidencebased controlled clinical trials. Questions/Purposes We asked: (1) Does a collagenase clostridium histolyticum (CCH) injection lyse shoulder capsule collagen in adhesive capsulitis and at what dose? (2) Can a shoulder capsule injection be administered extraarticularly? (3) Do CCH injections result in better scores for pain and function than can be achieved with physical therapy among patients with adhesive capsulitis?Methods First, 60 patients with adhesive capsulitis were evaluated by clinical examination. To make the diagnosis of adhesive capsulitis, a patient had to have restricted active ROM of at least 60°in total active ROM in the affected shoulder compared with the unaffected contralateral shoulder; with the scapula stabilized, external rotation with the elbow at the side was a very important determinant. Patients were randomized to receive a single injection of 0.5 mL placebo or 0.145, 0.29, or 0.58 mg CCH. All 60 patients were followed up at 30 days. After that, if patients did not attain treatment thresholds they were eligible for up to five open-label 0.58-mg collagenase injections. For the longer-term followup in the open-label phase, 53 patients (83%) were followed to 12 months, 46 (77%) for 24 months, 36 (60%) for 36 months, 37 (62%) for 48 months, and 25 (42%) for 60 months. The extraarticular injection was directed at the anterior shoulder capsule with the patient in the supine position. To prove that these injections could be delivered reliably to the anterior shoulder capsule extraarticularly, the next study involved volunteers without adhesive capsulitis, in which 10 volunteers received a 10-mL injection of normal saline under ultrasound guidance. Finally, to determine the efficacy and dosing of CCH, four cohorts of 10 patients received up to three ultrasoundguided injections separated by 21 days. These injections were administered at one of four dose-volume levels. A fifth cohort of 10 patients was used as a control group and performed standardized home shoulder exercises only. All patients performed standardized home shoulder exercises three times daily. For Study 3, followup was at 22, 43, 64, and 92 days. No patients were lost to followup. Results In the first study, a single CCH injection did not provide clinically important improvements from baseline in active ROM, passive ROM, and function and pain scores compared with patients who received placebo. UltrasoundThe Stony Brook University Research Foundation and MAB and EDW received funding from Auxilium Pharmaceutical, Inc.

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Section: Discussionsupporting

confidence: 82%

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

Badalamente

Wang

2016

Clinical Orthopaedics &Amp; Related Research

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“…Initial trials demonstrated CCH to be most effective in patients with contractures less than 50 degrees, though it was still effective in some patients with more severe contractures, and a recent study found 3-year recurrence rates of 27% at MCP and 56% at PIP joints (35% overall). 4,5,14,18 Our data show a major shift in the treatment of Dupuytren disease away from open procedures and toward CCH injection. The ability to use CCH to treat both mild and more advanced Dupuytren disease, with a recurrence rate falling somewhere between fasciectomies and fasciotomies, is likely 1 reason why CCH appears to be increasing in popularity in comparison with open procedures.…”

Section: Discussionmentioning

confidence: 74%

Trends in the Treatment of Dupuytren Disease in the United States Between 2007 and 2014

Lipman

Carstensen

Deal

2016

Hand (New York, N,Y.)

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Background: Dupuytren disease is a common fibroproliferative disorder. Multiple procedural treatment options are available, with Collagenase Clostridium Histolyticum (CCH) injection being introduced in 2010. The purpose of this study was to investigate trends in the treatment of Dupuytren disease in the United States between 2007 and 2014. Methods: The PearlDiver Humana database was queried using International Classification of Diseases, Ninth Revision (ICD-9) and Current Procedural Terminology (CPT) codes for patients with Dupuytren disease that received percutaneous needle aponeurotomy (PNA), fasciotomy, fasciectomy, and CCH injection. Patients were filtered by age, number of comorbidities, and gender. Change in composition of treatments over time was analyzed for each demographic group between 2007 and 2014. Results: Patients presenting to clinic for Dupuytren disease increased from 1118 to 3280, with unchanging treatment percentage of 41. Percent fasciotomies and fasciectomies decreased from 5% to 3% and 33% to 21%, while CCH injection increased to 11% by 2012 to 2014. Percent fasciotomies decreased (P < .05) in younger healthier (age <65, 0-1 comorbidities) and older less healthy (age 65-74, 4+ comorbidities) populations. Percent fasciectomies decreased significantly in nearly all age and comorbidity groups, but by greater amounts in patients with 2+ comorbidities with increasing age. Percent CCH injections increased in all groups, at rates similar to the losses seen in open procedures. Conclusions: CCH injections have risen to substantial levels, with corresponding decreases in the percentage of patients receiving fasciotomies and fasciectomies. Patient age, comorbidities, and gender appear to have influence on the treatment chosen, likely due to their effects on surgical risk and the importance of timely return to activity.

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“…We recently reported interim 3-year results. 11 At that time, of 623 joints that had previously demonstrated successful treatment (ie, 5 contracture), 35% (217 of 623) had a recurrence (! 20 increase with a palpable cord and/or secondary surgical/medical intervention).…”

mentioning

confidence: 99%

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

Peimer

Blazar

Coleman

et al. 2015

The Journal of Hand Surgery

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184

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Dupuytren Contracture Recurrence Following Treatment with Collagenase Clostridium Histolyticum (CORDLESS Study): 3-Year Data

Cited by 151 publications

References 31 publications

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

Trends in the Treatment of Dupuytren Disease in the United States Between 2007 and 2014

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

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