Dupuytren ContracturePhase 4DETECTNCT03192020
Trial Comparing Treatment Strategies in Dupuytren's Contracture
A Phase 4 study testing Percutaneous needle fasciotomy (PNF), Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex] and Limited fasciectomy (LF) in people with Dupuytren Contracture, run by Tampere University at 6 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Percutaneous needle fasciotomy (PNF), Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex] and Limited fasciectomy (LF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 6 sitesFinland
- Study dates
- 15 Sep 2017to 31 May 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Helsinki University hospital
Helsinki, Uusimaa, 00029
Central Hospital of Central Finland
Jyväskylä, Central Finland, 40620
Kuopio University hospital
Kuopio, Northern Savonia, 70029
Oulu University hospital
Oulu, North Ostrobothnia, 90220
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Turku University Hospital
Turku, Southwest Finland, 20521
About this study
Official title: DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
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.
Read the 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.
- Conditions
- Dupuytren Contracture
- Being tested
- Percutaneous needle fasciotomy (PNF), Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex], Limited fasciectomy (LF)
- Keywords
- Hand, Xiapex, Xiaflex, Clostridium histolyticum collagenase, Needle, Surgery, Aponeurectomy, Aponeurotomy, Fasciotomy, Fasciectomy, Dupuytren's disease, Dupuytren's contracture, Contracture, Connective tissue disease
- Medical subject headings
- Dupuytren Contracture, Contracture, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous needle fasciotomy (PNF)Procedure or surgery
Also called Percutaneous needle aponeurotomy
The division of the cord can be made under local anesthesia in the clinic and takes only a few minutes to perform. It can be performed whenever the cord is palpable. There are only puncture wounds left, and hence, the patient can start normal use of the hand the day after the procedure. If patient seeks for a treatment and the recurrence of the disease can not be treated by the PNF or patient is not willing to new PNF patient will be treated with LF.
Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]Drug
Also called [Xiapex]
CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord at least three different places in the outpatient clinic and the cord can be ruptured by gently force after one to three days. If patient seeks for a treatment and the recurrence of the disease can not be treated by the CCH or patient is not willing to new CCH patient will be treated with LF.
Limited fasciectomy (LF)Procedure or surgery
Also called Limited aponeurectomy
LF is performed in general or regional anesthesia in operating room. Constricting cords will be excised under direct vision. LF has been the dominant technique of surgical treatment. If patient seeks for a treatment the recurrence of the disease will be treated with LF as long as needed.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous needle fasciotomy (PNF) | Experimental | PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle. Receives: Procedure: Percutaneous needle fasciotomy (PNF); Procedure: Limited fasciectomy (LF) |
| Collagenase clostridium histolyticum (CCH) | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]; Procedure: Limited fasciectomy (LF) |
| Limited fasciectomy (LF) | Active comparator | In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. Receives: Procedure: Limited fasciectomy (LF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success
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.
Measured: 5 year follow-ups
Secondary outcomes (18)
QuickDASH
QuickDASH questionnaire is a validated upper extremity specific questionnaire consisting of 11 tasks/questions about the functional capacity and the pain.
Measured: 3 months, 2, 5 and 10 year follow-ups
Perceived hand function
Perceived hand function will be assessed pre- and postoperatively by VAS scale.
Measured: 3 months, 2, 5 and 10 year follow-ups
Global rating
Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better: This question is also used as anchor question in the MCII analysis in which +1 and +2 are considered to present meaningful improvement to the patient.
Measured: 3 months, 2, 5 and 10 year follow-ups
EQ-5D-3L
EQ-5D-3L is a generic instrument for assessing quality of life comprising 5 dimensions and VAS for health level.
Measured: 3 months, 2, 5 and 10 year follow-ups
Rate of Patient Accepted Symptom State
PASS is a relevant patient-centered outcome measurement, which reflects the overall state in which patients consider themselves as being well. It is a state of the symptoms between complete remission and subjective dissatisfaction with the symptoms.
Measured: 3 months, 2, 5 and 10 year follow-ups
Rate of patients achieving clinically significant improvement
Percentage of patients achieving clinically significant improvement (50% better PED) will be assessed.
Measured: 10 year follow-up
Rate of patients achieving full contracture release
Percentage of patients achieving full contracture release (PED 0°-5°) will be assessed.
Measured: 3 months, 2, 5 and 10 year follow-ups
Willingness to undergo same treatment
Patient satisfaction with the treatment will be assessed by a simple "yes" or "no" question: "Would you prefer the same treatment again, if the result would be the same as it is now?"
Measured: 3 months and 2 year follow-ups
Major adverse events
In the trial will be reported major adverse events, which include: tendon rupture, nerve injury, arterial injury, CRPS and infection, skin rupture or hematoma that needs hospitalization/revision surgery.
Measured: 3 months, 2, 5 and 10 year follow-ups
Extension deficits
The total passive extension deficit (TPED) and passive extension deficit (PED) of metacarpophalangeal (MPJ) and proximal interphalangeal (PIPJ) joints are used in almost all of the DC studies. Most of the studies used the PED as their primary outcome. In this trial, the TPED and PED of MPJ and PIPJ are used as secondary outcomes.
Measured: 3 months, 2, 5 and 10 year follow-ups
Total maximum flexion
Patients are seeking help for their extension deficit in DC but in the end flexion of the fingers is more important for the hand function. Our treatments should not jeopardize finger flexion in an effort to reduce the extension deficit.
Measured: 3 months, 2, 5 and 10 year follow-ups
Expenses
The costs are assessed by allocating previously estimated costs for interventions to each of the treatment arm.
Measured: 2, 5 and 10 year follow-ups
Progression of the disease
Recurrence or extension is treated if the patient contacts the study center and requires new treatment (ie, patient is not in the PASS anymore) and at least 20° flexion contracture is observed in one of the joints. Progression of disease is measured and reported in three levels: (1) rate of reinterventions in the arm due to recurrence or extension of the disease (clinically relevant progression); (2) costs of reinterventions (impact of progression); and (3) change in TPED in those patients who do not require further treatments (clinically irrelevant progression).
Measured: 2, 5 and 10 year follow-ups
Recurrence of the disease
In this study recurrence is defined when patient considers not being in PASS anymore and seeks for further treatment, and has at least 20° contracture.
Measured: 2, 5 and 10 year follow-ups
Extension of the disease
Extension means that the disease will be activated in other rays than treated after the treatment.
Measured: 2, 5 and 10 year follow-ups
Progression-free-survival
Progression-free-survival will be counted to each arm as mean time.
Measured: 2, 5 and 10 year follow-ups
Favored treatment modality questionnaire
Favored treatment modality will be asked from patients who undergo several treatment modalities (i.e. LF after CCH or PNF). Outcome will be assessed by question: "If you presented with a contracture for the first time now, would you prefer needle fasciotomy/injectable drug as the primary treatment or would prefer having surgery at first place?"
Measured: 2, 5 and 10 year follow-ups
Rate of success
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.
Measured: 3 months, 2 and 10 year follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Sep 2017
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District, Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Medcare Oy, Finnish Institute for Health and Welfare, Orton Orthopaedic Hospital
- Responsible party
- Principal investigator, Olli Leppänen, Tampere University
- Investigators
- Mikko P Räisänen, M.D., Principal investigator, Tampere University HospitalHarry J Göransson, M.D., Ph.D., adjunct professor, Principal investigator, Tampere University HospitalAleksi RP Reito, M.D., Ph.D., adjunct professor, Principal investigator, Central Finland Hospital DistrictHannu Kautiainen, MSc, Principal investigator, Medcare LtdAntti OV Malmivaara, M.D., Ph.D., adjunct professor, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192020
- Sponsor's protocol ID
- R17022M
- Acronym
- DETECT
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2017
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the IPD will be shared with other researchers by request.
Publications
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.
PubMed 29599391Raisanen 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.
PubMed 38346307Karjalainen VL, Soikkeli J, Raisanen MP, Leppanen OV, Reito A, Stjernberg-Salmela S, Buchbinder R, Karjalainen T. Progression of Dupuytren Contracture: A Randomized Controlled Trial Comparing Surgery, Needle Fasciotomy, and Collagenase Injection. Plast Reconstr Surg. 2026 Jul 1;158(1):101-112. doi: 10.1097/PRS.0000000000012666. Epub 2025 Dec 4.
PubMed 41334972
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
- ClinicalTrials.gov ID
- NCT03192020
- Acronym / sponsor ID
- DETECT / R17022M
- Conditions
- Dupuytren Contracture
- Keywords
- Hand, Xiapex, Xiaflex, Clostridium histolyticum collagenase, Needle, Surgery, Aponeurectomy, Aponeurotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Central Finland Hospital District, Helsinki University Central Hospital, Turku University Hospital, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Medcare Oy, Finnish Institute for Health and Welfare, Orton Orthopaedic Hospital
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous needle fasciotomy (PNF) | Experimental | Procedure: Percutaneous needle fasciotomy (PNF), Procedure: Limited fasciectomy (LF)PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle. |
| Collagenase clostridium histolyticum (CCH) | Experimental | Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex], Procedure: Limited fasciectomy (LF)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. |
| Limited fasciectomy (LF) | Active comparator | Procedure: Limited fasciectomy (LF)In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous needle fasciotomy (PNF)Also: Percutaneous needle aponeurotomyThe division of the cord can be made under local anesthesia in the clinic and takes only a few minutes to perform. It can be performed whenever the cord is palpable. There are only puncture wounds left, and hence, the patient can start normal use of the hand the day after the procedure. If patient seeks for a treatment and the recurrence of the disease can not be treated by the PNF or patient is not willing to new PNF patient will be treated with LF. | Procedure or surgery | Percutaneous needle fasciotomy (PNF) |
| Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]Also: [Xiapex]CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord at least three different places in the outpatient clinic and the cord can be ruptured by gently force after one to three days. If patient seeks for a treatment and the recurrence of the disease can not be treated by the CCH or patient is not willing to new CCH patient will be treated with LF. | Drug | Collagenase clostridium histolyticum (CCH) |
| Limited fasciectomy (LF)Also: Limited aponeurectomyLF is performed in general or regional anesthesia in operating room. Constricting cords will be excised under direct vision. LF has been the dominant technique of surgical treatment. If patient seeks for a treatment the recurrence of the disease will be treated with LF as long as needed. | Procedure or surgery | Collagenase clostridium histolyticum (CCH), Limited fasciectomy (LF), Percutaneous needle fasciotomy (PNF) |
Primary outcome
Rate of success
Time frame: 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.
18 secondary outcomes
QuickDASH
Time frame: 3 months, 2, 5 and 10 year follow-ups
Perceived hand function
Time frame: 3 months, 2, 5 and 10 year follow-ups
Global rating
Time frame: 3 months, 2, 5 and 10 year follow-ups
EQ-5D-3L
Time frame: 3 months, 2, 5 and 10 year follow-ups
Rate of Patient Accepted Symptom State
Time frame: 3 months, 2, 5 and 10 year follow-ups
Rate of patients achieving clinically significant improvement
Time frame: 10 year follow-up
Rate of patients achieving full contracture release
Time frame: 3 months, 2, 5 and 10 year follow-ups
Willingness to undergo same treatment
Time frame: 3 months and 2 year follow-ups
Major adverse events
Time frame: 3 months, 2, 5 and 10 year follow-ups
Extension deficits
Time frame: 3 months, 2, 5 and 10 year follow-ups
Total maximum flexion
Time frame: 3 months, 2, 5 and 10 year follow-ups
Expenses
Time frame: 2, 5 and 10 year follow-ups
Progression of the disease
Time frame: 2, 5 and 10 year follow-ups
Recurrence of the disease
Time frame: 2, 5 and 10 year follow-ups
Extension of the disease
Time frame: 2, 5 and 10 year follow-ups
Progression-free-survival
Time frame: 2, 5 and 10 year follow-ups
Favored treatment modality questionnaire
Time frame: 2, 5 and 10 year follow-ups
Rate of success
Time frame: 3 months, 2 and 10 year follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29599391Raisanen 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.
- Results publication: PubMed 38346307Raisanen 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.
- Derived from this study: PubMed 41334972Karjalainen VL, Soikkeli J, Raisanen MP, Leppanen OV, Reito A, Stjernberg-Salmela S, Buchbinder R, Karjalainen T. Progression of Dupuytren Contracture: A Randomized Controlled Trial Comparing Surgery, Needle Fasciotomy, and Collagenase Injection. Plast Reconstr Surg. 2026 Jul 1;158(1):101-112. doi: 10.1097/PRS.0000000000012666. Epub 2025 Dec 4.
- Individual participant dataSharing planned: Yes. All the IPD will be shared with other researchers by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikko P Räisänen, M.D. principal investigator
Tampere University Hospital
Harry J Göransson, M.D., Ph.D., adjunct professor principal investigator
Tampere University Hospital
Aleksi RP Reito, M.D., Ph.D., adjunct professor principal investigator
Central Finland Hospital District
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous needle fasciotomy (PNF), Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex] and Limited fasciectomy (LF) in people with Dupuytren Contracture, run by Tampere University at 6 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success (time frame: 5 year follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.