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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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)
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

Other trials in Finland

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.

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 groups in NCT03192020
Study groupRoleWhat they receive
Percutaneous needle fasciotomy (PNF)ExperimentalPNF 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)ExperimentalGeneric 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 comparatorIn 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Progression-free-survival

    Progression-free-survival will be counted to each arm as mean time.

    Measured: 2, 5 and 10 year follow-ups

  17. 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

  18. 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.

  1. First posted19 Jun 2017
  2. Study start15 Sep 2017
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2031 (estimated)

Resources

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)
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 29599391
  • 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.

    PubMed 38346307
  • Karjalainen 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

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.

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