Trial Comparing Treatment Strategies in Dupuytren's Contracture (DETECT)

Tampere University

Status and phase: Active, not recruiting; Phase 4

Conditions: Dupuytren Contracture

Treatments: Procedure: Limited fasciectomy (LF); Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]; Procedure: Percutaneous needle fasciotomy (PNF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03192020

R17022M

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

302 participants in 3 patient groups

Percutaneous needle fasciotomy (PNF)

Experimental group

Description:

PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle.

Treatment:

Procedure: Percutaneous needle fasciotomy (PNF)

Procedure: Limited fasciectomy (LF)

Collagenase clostridium histolyticum (CCH)

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]

Procedure: Limited fasciectomy (LF)

Limited fasciectomy (LF)

Active Comparator group

Description:

In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision.

Treatment:

Procedure: Limited fasciectomy (LF)