DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 302
- 试验地点
- 12
- 主要终点
- Rate of success
研究概览
简要总结
Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most cost-effective in treating Dupuytren´s contracture. Short- and long-term results will be published.
详细描述
Dupuytren's contracture (DC) is a fibroproliferative disorder of the palmar fascia, which in time leads to flexion contracture in one or more fingers. Etiology of the disease is still unknown, but it strongly seems that genetic factors play a major role. DC is associated most commonly with Caucasian population groups from Northern Europe. The estimated global prevalence among whites is 3% to 6% and increases with age. Men women ratio is 7:1. There is no definitive cure for DC. The treatment aims at relieving the symptoms by releasing the contracture by percutaneous or operative techniques.
The investigators planned a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing the cost-effectiveness of 1) collagenase clostridium histolyticum followed by limited fasciectomy in non-responsive cases, 2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and 3) primary limited fasciectomy in short- and long-term follow-up in DC.
Protocol is approved by Tampere university hospital institutional review board and Finnish Medicine Agency (Fimea). All patients will give written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.
Treatment of Duputren's contracture aims at reducing the functional deficit caused by the contracture. Recurrence is almost inevitable if the follow-up is long enough. Therefore, the investigators aim to analyze the effectiveness of three different treatment strategies in long-term follow-up, in addition to short-term follow-up, which include multiple interventions rather than just single intervention. The investigators chose a pragmatic primary outcome, which comprises both objective and subjective standpoint and reflects the needs of the patients as well as goals of the healthcare system. Furthermore, our short-term results give good high quality level evidence of effectiveness of all the three treatments and long-term follow-up a good perspective to the cost-effectiveness of the strategies.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors who measured index, middle, ring and small fingers' flexion and extension degrees were blinded. Patients had opaque gloves in their hand when visiting the blinded outcome assessor. Due to the nature of the treatments it was not possible to blind patients, leading investigators or research assistants. To minimize any bias in interpreting the findings, we blinded treatment allocation in the draft results manuscript with groups labelled as A, B and C. The writing committee reached consensus on the interpretation of the findings prior to being unblinded to group assignments.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ≥20° passive extension deficit in metacarpophalangeal (MPJ) or proximal interphalangeal joint (PIPJ), or TPED ≥30° in MPJ and PIPJ of finger/fingers II-V
- •age > 18 years
- •palpable cord
- •provision of informed consent
- •ability to fill the Finnish versions of questionnaires.
排除标准
- •recurrent contracture in the finger to be treated
- •neurologic condition causing the loss of function of the finger to be treated
- •contraindication for collagenase clostridium histolyticym (Xiapex/Xiaflex ®)
- •pregnant or breast feeding
- •total passive extension deficit > 135° (Tubiana stage 4) in finger to be treated
- •rheumatoid arthritis
- •previous fracture in finger to be treated, which affects range of motion of MPJ or PIPJ
- •age > 80 years
研究组 & 干预措施
Collagenase clostridium histolyticum (CCH)
Generic name of the drug is collagenase clostridium histolyticum. Dosage form is injectable powder, dosage 0.58 mg and frequency is one injection in four weeks up to three times. One injection is performed normally at least to three different places in the cord.
干预措施: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex] (Drug)
Percutaneous needle fasciotomy (PNF)
PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle.
干预措施: Percutaneous needle fasciotomy (PNF) (Procedure)
Percutaneous needle fasciotomy (PNF)
PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle.
干预措施: Limited fasciectomy (LF) (Procedure)
Collagenase clostridium histolyticum (CCH)
Generic name of the drug is collagenase clostridium histolyticum. Dosage form is injectable powder, dosage 0.58 mg and frequency is one injection in four weeks up to three times. One injection is performed normally at least to three different places in the cord.
干预措施: Limited fasciectomy (LF) (Procedure)
Limited fasciectomy (LF)
In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision.
干预措施: Limited fasciectomy (LF) (Procedure)
结局指标
主要结局
Rate of success
时间窗: 5 year follow-ups
Success is a composite outcome comprising of 1) at least 50% contracture release from the recruitment and 2) patient is in patient accepted symptom state (PASS). PASS is defined by question: "Would you be satisfied and not in need for any other treatment if the functional impairment caused by the contracture would remain the same as it is today for the rest of your life?". Primary time point is five years' follow-up visit.
次要结局
- QuickDASH(3 months, 2, 5 and 10 year follow-ups)
- Perceived hand function(3 months, 2, 5 and 10 year follow-ups)
- Global rating(3 months, 2, 5 and 10 year follow-ups)
- EQ-5D-3L(3 months, 2, 5 and 10 year follow-ups)
- Rate of Patient Accepted Symptom State(3 months, 2, 5 and 10 year follow-ups)
- Rate of patients achieving clinically significant improvement(10 year follow-up)
- Rate of patients achieving full contracture release(3 months, 2, 5 and 10 year follow-ups)
- Willingness to undergo same treatment(3 months and 2 year follow-ups)
- Major adverse events(3 months, 2, 5 and 10 year follow-ups)
- Extension deficits(3 months, 2, 5 and 10 year follow-ups)
- Total maximum flexion(3 months, 2, 5 and 10 year follow-ups)
- Expenses(2, 5 and 10 year follow-ups)
- Progression of the disease(2, 5 and 10 year follow-ups)
- Recurrence of the disease(2, 5 and 10 year follow-ups)
- Extension of the disease(2, 5 and 10 year follow-ups)
- Progression-free-survival(2, 5 and 10 year follow-ups)
- Favored treatment modality questionnaire(2, 5 and 10 year follow-ups)
- Rate of success(3 months, 2 and 10 year follow-ups)
研究者
Olli Leppänen
M.D., Ph.D.
Tampere University