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Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

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ClinicalTrials.gov Identifier: NCT03406338
Recruitment Status : Enrolling by invitation
First Posted : January 23, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Isam Atroshi, Region Skane

Brief Summary:
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with either surgery or collagenase injection. Half of the participants will be treated with surgery while the other half will receive collagenase injection.

Condition or disease Intervention/treatment Phase
Dupuytren Disease of Finger Procedure: Fasciectomy Drug: Collagenase Clostridium Histolyticum Phase 4

Detailed Description:
No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel Group, ratio 1:1.
Masking: Single (Outcomes Assessor)
Masking Description: Before examination the patients will wear thin gloves in the treated hands to conceal possible surgical scars so the examiner will be blinded to the group allocation.
Primary Purpose: Treatment
Official Title: Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgical fasciectomy
Fasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures
Procedure: Fasciectomy
Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.
Other Name: Surgery

Experimental: Collagenase Clostridium Histolyticum
Injection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures
Drug: Collagenase Clostridium Histolyticum
Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia
Other Name: Non-surgical treatment




Primary Outcome Measures :
  1. Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) [ Time Frame: Change from baseline to 3 months ]
    Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)

  2. Proportion of patients with worsening in total active extension deficit ≥20 degrees [ Time Frame: 24 months compared to 3 months ]
    Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)


Secondary Outcome Measures :
  1. 11-item disabilities of the arm, shoulder and hand (QuickDASH) score [ Time Frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months ]
    A patient-reported outcome measure of activity limitations related to upper extremity disorders, with total score range from 0 (best) to 100 (worst)

  2. EuroQoL 5-dimensions (EQ-5D) Index [ Time Frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months ]
    Health-status and quality-of-life patient-reported measure, consists of 5 items, a single weighted score, the EQ-5D index, is calculated from the 5 dimensions, ranging from -0.594 (worst) to 1.0 (perfect health)

  3. Pain score [ Time Frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months ]
    Visual analog scale of pain in the treated hand, score range from 0 (best) to 100 (worst)

  4. Satisfaction score [ Time Frame: 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months ]
    Visual analog scale of patient satisfaction with treatment outcome, score range from 0 (best) to 100 (worst)

  5. Adverse events [ Time Frame: Anytime during 24 months after treatment ]
    All observed and reported adverse events will be recorded on a standard form. Serious adverse events include nerve, artery or tendon damage, deep infection, complex regional pain syndrome and any complications requiring surgery or hospital admission.

  6. Costs [ Time Frame: From baseline through 24 months ]
    Total treatment cost, direct (medications, surgery, materials, visits etc) and indirect (sick leave related to the treatment)

  7. Total active motion [ Time Frame: Change from baseline to 3 months, 12 months, 24 months and 60 months ]
    Sum of active range of motion of metacarpophalangeal, proximal intephalangeal and distal interphalangeal joints of the treated finger

  8. Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) [ Time Frame: Change from baseline to 12 months, 24 months and 60 months ]
    Active extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)

  9. Proportion of patients with worsening in total active extension deficit ≥20 degrees [ Time Frame: 60 months compared to 3 months ]
    Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)

  10. Palmar pain score [ Time Frame: Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months. ]
    2-item scale inquiring about pain in the palm and related activity limitations, total score range 0 (best) to 100 (worst)

  11. Cold intolerance symptom severity score [ Time Frame: Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months. ]
    6-item scale inquiring about symptoms of cold intolerance, total score range 4 (best) to 100 (worst)

  12. Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints) [ Time Frame: Change from baseline to 24 months and 60 months ]
    Passive extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)



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

Inclusion Criteria:

  • Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
  • Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy or collagenase injections.
  • Palpable cord in the palm and/or affected finger causing the recurrent contracture.
  • No surgery or collagenase in the finger with recurrent contracture in the past 12 months.

Exclusion Criteria:

  • Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
  • Signs of nerve or vascular injury in the affected finger.
  • Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
  • Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
  • Previous trauma or other surgery involving the affected finger.
  • More than 2 previous surgeries or collagenase treatments in the affected finger.
  • Previous treatment with both fasciectomy and collagenase in the affected finger.
  • Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
  • Patient refusal to participate

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): NCT03406338


Locations
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Sweden
Department of Orthopedics Hässleholm-Kristianstad
Hässleholm, Sweden, SE 28125
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Isam Atroshi, MD, PhD Lund University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isam Atroshi, Professor, Region Skane
ClinicalTrials.gov Identifier: NCT03406338     History of Changes
Other Study ID Numbers: Hlm_DC
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Dupuytren Contracture
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases