Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture

Lc, Hurst; Ma, Badalamente; Vr, Hentz; Rn, Hotchkiss; Kaplan, F. Thomas D.; Ra, Meals; Tm, Smith; Rodzvilla, J

doi:10.1056/nejmoa0810866

Cited by 643 publications

(627 citation statements)

References 31 publications

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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%

“…It is an FDA-approved enzymatic injection treatment for Dupuytren's contracture in adult patients with a palpable cord [12]. CCH injection treatment for Dupuytren's contracture was first developed at Stony Brook University Medical Center (Stony Brook, NY, USA) [5]. Considering that the CCH mechanism of action on collagen might be the same for adhesive capsulitis as it is in Dupuytren's contracture, we thought that the effects of CCH might prove clinically beneficial to patients with adhesive capsulitis.…”

Section: Introductionmentioning

confidence: 99%

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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%

Section: Introductionmentioning

confidence: 99%

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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“…Four studies describing collagenase injection met the inclusion criteria [1][2][3]11]. Two studies were prospective, double-blind, placebo-controlled randomized studies (level I), and two were prognostic, prospective studies (level II).…”

Section: Study Characteristicsmentioning

confidence: 99%

A Systematic Review of Outcomes of Fasciotomy, Aponeurotomy, and Collagenase Treatments for Dupuytren's Contracture

Chen

Srinivasan

Shauver

et al. 2011

Hand (New York, N,Y.)

114

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Background Needle aponeurotomy and collagenase injection are alternative treatments of Dupuytren's contracture to open partial fasciectomy; however, reported data are difficult to interpret without a formal systematic review. Methods A Medline, EMBASE, and Cochrane database search was performed, and 277 articles were identified. Articles were stratified by level of evidence, and those of the highest level for each technique were included. Evidence available for needle aponeurotomy was of low quality so only cohorts larger than 100 patients were included. Results The sample size of patients for open partial fasciectomy ranged from 37-261. The recurrence rate ranged from 12-39%, with mean follow-up time of 1.5-7.3 years. The complication rate ranged from 14-67%. Complications included nerve division (2-5%), infection (4-12%), neurapraxia (0.4-52%), and regional pain syndrome (2-13%). For needle aponeurotomy the sample size ranged from 117-211. The recurrence rate ranged from 50-58%, with mean follow-up time of 3-5 years. With regard to collagenase injection, the sample size ranged from 13-204. The recurrence rate ranged from 10-31%, with mean follow-up time of 120 days to 4 years. For the two latter procedures, adverse effects consisted primarily of skin tears (9-25%). Kruskal-Wallis testing demonstrated that the recurrence rate was significantly higher for needle aponeurotomy than for open partial fasciectomy (p=0.001), and the recurrence rate was significantly higher for open partial fasciectomy than for collagenase injection (p=0.001). Conclusions The recurrence rates and types of complications differ between open partial fasciectomy and needle aponeurotomy or collagenase injection. Long-term outcomes have not been well reported.

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“…When it comes to efficacy of a given therapeutic option in Dupuytren's disease, change in range of motion (in degrees) is commonly used as a primary outcome measure, and has been used, for example, in the Collagenase Option for Reduction of Dupuytren's (CORD 1) RCT using collagenase injections (5). Recently, the DASH score was chosen as a primary end point of an RCT analyzing the role of splinting in Dupuytren's disease (6).…”

mentioning

confidence: 99%

German version of the Unité Rhumatologique des Affections de la Main (URAM) scale in Dupuytren's disease: The need for a uniform definition of recurrence. Comment on the article by Beaudreuil et al

Knobloch¹,

Kuhn²,

Sorg³

et al. 2012

Arthritis Care & Research

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Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture

Abstract: Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. (ClinicalTrials.gov number, NCT00528606.)

Cited by 643 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

A Systematic Review of Outcomes of Fasciotomy, Aponeurotomy, and Collagenase Treatments for Dupuytren's Contracture

German version of the Unité Rhumatologique des Affections de la Main (URAM) scale in Dupuytren's disease: The need for a uniform definition of recurrence. Comment on the article by Beaudreuil et al

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