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

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ClinicalTrials.gov Identifier: NCT03192020
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Central Hospital of Central Finland
Helsinki University Central Hospital
Turku University Hospital
Tampere University Hospital
Kuopio University Hospital
Oulu University Hospital
Medcare Plc
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Olli Leppänen, Tampere University

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.

Condition or disease Intervention/treatment Phase
Dupuytren Contracture Procedure: Percutaneous needle fasciotomy Drug: Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex] Procedure: Limited fasciectomy Phase 4

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, 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 long-term follow-up gives a good perspective to the cost-effectiveness of the strategies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DupuytrEn Treatment EffeCtiveness Trial (DETECT): Prospective, Randomised, Controlled, Outcome Assessor-blinded, Three-armed Parallel 1:1:1, Multicenter 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
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Percutaneous needle fasciotomy Procedure: Percutaneous needle fasciotomy
PNF is a treatment in which the cord causing the contracture is not excised, but only divided with a hypodermic needle. 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.

Procedure: Limited fasciectomy
In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. LF is performed in general or regional anesthesia in operating room. LF has been the dominant technique of surgical treatment.

Active Comparator: Collagenase clostridium histolyticum
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.
Drug: Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex]
CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord in the outpatient clinic and the cord can be ruptured by gently force after a day or two.

Procedure: Limited fasciectomy
In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. LF is performed in general or regional anesthesia in operating room. LF has been the dominant technique of surgical treatment.

Active Comparator: Limited fasciectomy Procedure: Limited fasciectomy
In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. LF is performed in general or regional anesthesia in operating room. LF has been the dominant technique of surgical treatment.




Primary Outcome Measures :
  1. Rate of success [ Time Frame: 5 year follow up ]
    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?".


Secondary Outcome Measures :
  1. Patient's trust of the treatment [ Time Frame: 10 year follow up ]
    The possible placebo or nocebo effect of treatment will be evaluated by asking the patient about the trust of the treatment.

  2. QuickDASH [ Time Frame: 10 year follow up ]
    QuickDASH questionnaire is a validated upper extremity specific questionnaire consisting of 11 tasks/questions about the functional capacity and the pain.

  3. Perceived hand function [ Time Frame: 10 year follow up ]
    Perceived hand function will be assessed pre- and postoperatively by VAS scale.

  4. EQ-5D-3L [ Time Frame: 10 year follow up ]
    EQ-5D-3L is a generic instrument for assessing quality of life comprising 5 dimensions and VAS for health level.

  5. Major adverse events [ Time Frame: 10 year follow up ]
    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.

  6. Passive extension deficit (PED) [ Time Frame: 10 year follow up ]
    PED will be measured.

  7. Range of motion (ROM) [ Time Frame: 10 year follow up ]
    ROM will be measured.

  8. Total passive extension deficit (TPED) [ Time Frame: 10 year follow up ]
    TPED will be measured.

  9. Total range of motion (TROM) [ Time Frame: 10 year follow up ]
    TROM will be measured.

  10. Rate of patients achieving full contracture release [ Time Frame: 10 year follow up ]
    Percentage of patients achieving full contracture release (PED 0°-5°) will be assessed.

  11. Rate of patients achieving clinically significant improvement [ Time Frame: 10 year follow up ]
    Percentage of patients achieving clinically significant improvement (50% better PED) will be assessed.

  12. Percentage of improvement in PED [ Time Frame: 10 year follow up ]
    Percentage of improvement in PED will be evaluated.

  13. Global rating [ Time Frame: 10 year follow up ]
    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.

  14. Rate of MCII [ Time Frame: 10 year follow up ]
    MCII reflects the level of meaningful change (as opposed to state) in scale, which it is measured in individual level.

  15. Expenses [ Time Frame: 10 year follow up ]
    The costs are assessed by allocating previously estimated costs for interventions to each of the treatment arm.

  16. Progression of the disease [ Time Frame: 10 year follow up ]
    Recurrence or extension is treated if the patient contacts the study centre 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, which patient wants to be treated. 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).

  17. Extension of disease [ Time Frame: 10 year follow up ]
    Extension means that the disease will be activated in other rays than treated after the treatment.

  18. Progression-free-survival [ Time Frame: 10 year follow up ]
    Progression-free-survival will be counted to each arm in median time.

  19. Favored treatment modality questionnaire [ Time Frame: 10 year follow up ]
    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 prefer PNF/CCH as the primary treatment or would prefer having surgery at first place?"

  20. Patient satisfaction to the treatment [ Time Frame: 10 year follow up ]
    In the trial will be assessed patient satisfaction to the treatment by simple "yes" or "no" question: "Would you be ready for the same treatment again, if the result would be as it is now?"

  21. Rate of Patient Accepted Symptom State [ Time Frame: 10 year follow up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with ≥20° passive extension deficit (PED) in metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint, or TPED of ≥30° in MP and PIP joints 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
  • TPED > 135° (Tubiana stage 4) in finger to be treated
  • rheumatoid arthritis
  • previous fracture in finger to be treated, which affects range of motion of MP or PIP joint
  • age > 80 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192020


Contacts
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Contact: Olli V Leppänen, M.D., Ph.D. +3583311611 olli.leppanen@fimnet.fi
Contact: Teemu V Karjalainen, M.D., Ph.D. +358445858633 teemukarjalainen@me.com

Locations
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Finland
Central Hospital of Central Finland Recruiting
Jyväskylä, Keski-Suomi, Finland, 40620
Contact: Teemu V Karjalainen, M.D., Ph.D.    +358142691811    teemu.karjalainen@ksshp.fi   
Contact: Toni T Luokkala, M.D.    +358142691811    toni.luokkala@ksshp.fi   
Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 33521
Contact: Antti K Kaivorinne, MD    +3583211611    antti.kaivorinne@pshp.fi   
Contact: Margit Karelson, MD    +3583211611    margit.karelson@pshp.fi   
Oulu University hospital Recruiting
Oulu, Pohjois-Pohjanmaa, Finland, 90220
Contact: Janne J Soikkeli, M.D.    +35883152011    janne.soikkeli@psshp.fi   
Kuopio University hospital Recruiting
Kuopio, Pohjois-Savo, Finland, 70029
Contact: Minna K Lappalainen, M.D.    +35817173311    minna.k.lappalainen@kuh.fi   
Helsinki University hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Susanna M Stjernberg-Salmela, M.D., Ph.D.    +35894711    susanna.stjernbeg-salmela@hus.fi   
Turku University Hospital Recruiting
Turku, Varsinais-Suomi, Finland, 20521
Contact: Markus JI Pääkkönen, M.D., Ph.D., adjunct prof    +35823130000    markus.paakkonen@tyks.fi   
Contact: Hanna-Stiina K Taskinen, M.D., Ph.D.    +35823130000    hanna-stiina.taskinen@tyks.fi   
Sponsors and Collaborators
Tampere University
Central Hospital of Central Finland
Helsinki University Central Hospital
Turku University Hospital
Tampere University Hospital
Kuopio University Hospital
Oulu University Hospital
Medcare Plc
National Institute for Health and Welfare, Finland
Investigators
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Principal Investigator: Mikko P Räisänen, M.D. Tampere University Hospital
Principal Investigator: Harry J Göransson, M.D., Ph.D., Adjunct professor Tampere University Hospital
Principal Investigator: Aleksi RP Reito, M.D., Ph.D. Central Finland Central Hospital
Principal Investigator: Hannu Kautiainen, M.A. Medcare Ltd
Principal Investigator: Antti OV Malmivaara, M.D., Ph.D., Adjunct professor National Institute for Health and Welfare, Finland
  Study Documents (Full-Text)

Documents provided by Olli Leppänen, Tampere University:
Study Protocol  [PDF] March 28, 2018
Informed Consent Form  [PDF] March 29, 2017


Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Protocol in BMJ Open access

Publications:
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Responsible Party: Olli Leppänen, M.D., Ph.D., Tampere University
ClinicalTrials.gov Identifier: NCT03192020     History of Changes
Other Study ID Numbers: R17022M
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the IPD will be shared with other researchers by request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available after the publication and it will be available for 15 years.
Access Criteria: Request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Olli Leppänen, Tampere University:
Hand dysfunction
Xiapex
Xiaflex
Aponeurectomy
Aponeurotomy
Dupuytren disease
Joint contracture
Surgery
Additional relevant MeSH terms:
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Dupuytren Contracture
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases