The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study
| Autor: | Brian Dean, Lawrence C. Hurst, R. Glenn Gaston, Søren Larsen, Stephen Coleman, James P. Tursi, Gary M. Pess, Gregory J. Kaufman, Brian M. Cohen |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Phases of clinical research Injections Intralesional Severity of Illness Index Collagenase clostridium histolyticum Collagenase clostridium histolyticum concurrent injections Dupuytren disease fixed flexion contracture range of motion DISEASE Dupuytren Contracture/diagnostic imaging Orthopedics and Sports Medicine Hand Strength/physiology Prospective Studies Range of Motion Articular Hand Strength Incidence (epidemiology) Middle Aged Dupuytren Contracture Microbial Collagenase Treatment Outcome medicine.anatomical_structure Clostridium histolyticum/enzymology Retreatment Female Range of motion medicine.drug medicine.medical_specialty Flexibility (anatomy) Risk Assessment Drug Administration Schedule range of motion medicine Humans Adverse effect fixed flexion contracture Aged Muscle contracture Dupuytren disease Dose-Response Relationship Drug business.industry Range of Motion Articular/drug effects Recovery of Function Surgery Radiography Microbial Collagenase/administration & dosage concurrent injections Clostridium histolyticum Interphalangeal Joint business Follow-Up Studies |
| Zdroj: | Gaston, R G, Larsen, S, Pess, G M, Coleman, S, Dean, B, Cohen, B M, Kaufman, G J, Tursi, J P & Hurst, L C 2015, ' The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand : A Prospective, Multicenter Study ', Journal of Hand Surgery (American Volume), vol. 40, no. 10, pp. 1963-1971 . https://doi.org/10.1016/j.jhsa.2015.06.099 |
| ISSN: | 0363-5023 |
| DOI: | 10.1016/j.jhsa.2015.06.099 |
| Popis: | Purpose To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs). Methods Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized. Results The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension. Conclusions Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment. Type of study/level of evidence Therapeutic III. |
| Databáze: | OpenAIRE |
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