Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
研究概览
简要总结
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.
详细描述
No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.
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
- Single (Outcomes Assessor)
盲法说明
Before examination the patients will wear thin gloves in the treated hands to conceal possible surgical scars so the examiner will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
- •Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
- •Palpable cord in the palm and/or affected finger causing the recurrent contracture.
- •No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.
排除标准
- •Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
- •Signs of nerve or vascular injury in the affected finger.
- •Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
- •Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
- •Previous trauma or other surgery involving the affected finger.
- •More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.
- •Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
- •Patient refusal to participate
研究组 & 干预措施
Surgical fasciectomy
Fasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures
干预措施: Fasciectomy (Procedure)
Collagenase Clostridium Histolyticum
Injection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures
干预措施: Collagenase Clostridium Histolyticum (Drug)
结局指标
主要结局
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
时间窗: Change from baseline to 3 months
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Proportion of patients with worsening in total active extension deficit ≥20 degrees
时间窗: 24 months compared to 3 months
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
次要结局
- Pain score(Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months)
- EuroQoL 5-dimensions (EQ-5D) Index(Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months)
- Satisfaction score(3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months)
- Adverse events(Anytime during 24 months after treatment)
- Costs(From baseline through 24 months)
- Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)(Change from baseline to 12 months, 24 months and 60 months)
- Proportion of patients with worsening in total active extension deficit ≥20 degrees(60 months compared to 3 months)
- Palmar pain score(Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.)
- Cold intolerance symptom severity score(Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.)
- Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)(Change from baseline to 24 months and 60 months)
- 11-item disabilities of the arm, shoulder and hand (QuickDASH) score(Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months)
- Total active motion(Change from baseline to 3 months, 12 months, 24 months and 60 months)