Clinical trial NCT03192020: Trial Comparing Treatment Strategies in Dupuytren's Contracture
Official title: DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dupuytren Contracture
Keywords: Hand
Xiapex
Xiaflex
Clostridium histolyticum collagenase
Needle
Surgery
Aponeurectomy
Aponeurotomy
Fasciotomy
Fasciectomy
Dupuytren's disease
Dupuytren's contracture
Contracture
Connective tissue disease
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
name: Helsinki University Central Hospital
name: Turku University Hospital
name: Tampere University Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Medcare Oy
name: Finnish Institute for Health and Welfare
name: Orton Orthopaedic Hospital
First posted: 2017-06-19
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, outcome assessor blinded, three parallel armed (1:1:1), superiority trial comparing needle fasciotomy, collagenase injection and surgery as primary intervention for people with treatment-naïve Dupuytren's contracture with a five-year follow-up.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of success
timeFrame: 5 year follow-ups
Secondary outcomes:
measure: QuickDASH
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Perceived hand function
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Global rating
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: EQ-5D-3L
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Rate of Patient Accepted Symptom State
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Rate of patients achieving clinically significant improvement
timeFrame: 10 year follow-up
measure: Rate of patients achieving full contracture release
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Willingness to undergo same treatment
timeFrame: 3 months and 2 year follow-ups
measure: Major adverse events
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Extension deficits
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Total maximum flexion
timeFrame: 3 months, 2, 5 and 10 year follow-ups
measure: Expenses
timeFrame: 2, 5 and 10 year follow-ups
measure: Progression of the disease
timeFrame: 2, 5 and 10 year follow-ups
measure: Recurrence of the disease
timeFrame: 2, 5 and 10 year follow-ups
measure: Extension of the disease
timeFrame: 2, 5 and 10 year follow-ups
measure: Progression-free-survival
timeFrame: 2, 5 and 10 year follow-ups
measure: Favored treatment modality questionnaire
timeFrame: 2, 5 and 10 year follow-ups
measure: Rate of success
timeFrame: 3 months, 2 and 10 year follow-ups
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Hospital of Central Finland
state: Keski-Suomi
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulu University hospital
state: Pohjois-Pohjanmaa
city: Kuopio
country: Finland
facility: Kuopio University hospital
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Tampere University Hospital
name: Mikko P Räisänen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Harry J Göransson, M.D., Ph.D., adjunct professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Central Hospital
name: Aleksi RP Reito, M.D., Ph.D., adjunct professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Medcare Ltd
name: Hannu Kautiainen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Finnish Institute for Health and Welfare
name: Antti OV Malmivaara, M.D., Ph.D., adjunct professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raisanen MP, Karjalainen T, Goransson H, Reito A, Kautiainen H, Malmivaara A, Leppanen OV. DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture. BMJ Open. 2018 Mar 28;8(3):e019054. doi: 10.1136/bmjopen-2017-019054.
citation: Raisanen MP, Leppanen OV, Soikkeli J, Reito A, Malmivaara A, Buchbinder R, Kautiainen H, Kaivorinne A, Stjernberg-Salmela S, Lappalainen M, Luokkala T, Ponkko A, Taskinen HS, Paakkonen M, Jaatinen K, Juurakko J, Karjalainen VL, Karjalainen T. Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial. Ann Intern Med. 2024 Mar;177(3):280-290. doi: 10.7326/M23-1485. Epub 2024 Feb 13.