Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in active extension deficit of PIP joint, in degrees, if applicable
研究概览
简要总结
Dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. A collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. While there is no cure, many treatment options are available to manage symptoms. One of these options is injectable collagenase clostridium histolyticum (CCH). CCH is a combination of two highly selective microbial collagenases that can disrupt collagen types I and III usually found in cords. Current standard of care after receiving a CCH injection is daily hand exercises and use of a static night brace for four months. However, there is limited evidence that use of a night splint after CCH injection has any benefit post-treatment. The goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after CCH injection. Study subjects will be adults 18 years of age or older with Dupuytren disease and contracture of one or more digits. Treatment includes collagenase clostridium histolyticum injection for Dupuytren flexion contraction, with randomization to static night splint or no splint.
详细描述
Patients with Dupuytren disease that meet inclusion criteria will be consented to participate. All patients will be randomized to splint or no splint group prior to treatment. Baseline data will be collected prior to treatment and will include demographics, measurement of joint flexion contracture(s) with a standard finger goniometer, and QuickDASH scores. All patients that participate will receive 1 injection of 0.58 mg of CCH into cord. After 24-48 hours, if needed, patient will return to clinic for extension manipulation of treated finger(s) to help facilitate rupture of cord. Following injection and/or manipulation, all patients will be instructed to perform a series of finger exercises daily that they will receive from a hand therapist. In addition, patients assigned to the splint group will be fitted for a static night splint that they will be instructed to wear nightly for 4 months. Splint compliance will be recorded by a survey at each follow up visit. Patients will return to clinic for routine follow up care at 1 month and 4 months during which their degree of contracture(s) and outcomes will be measured and recorded. The primary outcome measures of this study are improvement in active extension deficit of each joint and total active extension of each digit, in degrees. The secondary outcome measures are QuickDASH scores and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Contracture of 1 or more digits caused by palpable cord
- •PIP joint flexion contracture of 20 degrees or more or;
- •MCP joint flexion contracture of 20 degrees or more
排除标准
- •Age less than 18 years
- •Prior CCH injection for contracture less than 1 year before start of study
- •Prior surgical intervention for contracture less than 1 year before start of study
研究组 & 干预措施
No Splint Group
This group will receive Xiaflex injection only
干预措施: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (Drug)
Splint Group
This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension
干预措施: Xiaflex + Hand-Based Custom Orthosis (Combination Product)
结局指标
主要结局
Improvement in active extension deficit of PIP joint, in degrees, if applicable
时间窗: Baseline, 1 month, and 4 months
Clinical measurement of PIP joint extension with goniometer, in degrees, of treated finger
Improvement in active extension deficit of MCP joint, in degrees, if applicable
时间窗: Baseline, 1 month, and 4 months
Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger
Improvement in total active extension of each digit, in degrees
时间窗: Baseline, 1 month, and 4 months
Sum of MCP and PIP joint extension, in degrees, of treated finger
次要结局
- Functional Outcomes(Baseline, 1 month, and 4 months)
- Patient Satisfaction(1 month and 4 months)
- Compliance of Splint wearing (Splint group only)(1 month and 4 months)
研究者
Jason Nydick DO
Jason Nydick DO
Foundation for Orthopaedic Research and Education