Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02647619
Other study ID # 2639063
Secondary ID 2013-001221-13
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2013
Est. completion date April 2022

Study information

Verified date April 2022
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy. Materials and methods: 30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°. 1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.


Description:

Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications. There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis. The treatment arm of Xiapex in this study follows the recommendation as by the producer. The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended. The two procedures leave little scar tissue lessening the challenges posed by the reoperations. Recurrence rate of contracture following different treatments of Dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primary Dd disease (no earlier treatment for this condition of the hand involved) - Single digit involvement, one of the three ulnar digits - Average norwegian language skills. - MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ - Minimum 18 y.o. Exclusion Criteria: - Involvement of 2 fingers/joints - Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor - Pregnancy - Ongoing treatment with platelet inhibitors - Treatment with tetracycline 2 weeks prior to treatment date - Poor norwegian language skills - Participation in other studies 4 weeks prior or after treatment date - "Need to treat" of both hands

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Xiapex
Injection of collagenase of primary dupytren cord
Procedure:
Needle aponeurotomy
26 G needle multiple perforation tecqnique with local anesthetic

Locations

Country Name City State
Norway Akershus University Hospital Oslo Akershus

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Total Passive Extension Deficit 5 years
Secondary Quick Dash (Disabilities of the shoulder and Hand) 5 years
Secondary EQ5D (Euroqol 5 Dimensions) 5 years
Secondary Brief MHQ (Michigan Hand Questionare) 5 years
Secondary URAM (Unité Rhumatologique des Affections de la Main) 5 years
Secondary Jamar grip strength 1,4,26 weeks and one year.
Secondary VAS (Visual analogue scale) pain 0 is no pain, 10 maximum pain 1,4,26 weeks and one year
Secondary VAS (Visual analogue sale) satisfaction 0 is not satisfied, 10 maximum satisfied 1,4,26 weeks. 1,2 and 5 years
Secondary Complications AE,SAE,SUSAR 1,4,weeks One year
Secondary Recurrence def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ 1,4,26 weeks. 1,2 and 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT03155854 - The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring N/A
Active, not recruiting NCT03192020 - Trial Comparing Treatment Strategies in Dupuytren's Contracture Phase 4
Recruiting NCT05300893 - Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture N/A
Recruiting NCT01184586 - Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) Phase 2
Recruiting NCT04122313 - Post-contracture Release Radiation for Dupuytren's Disease
Withdrawn NCT01776892 - Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease Phase 3
Completed NCT02983162 - Is wGRS Associated With DD Recurrence?
Completed NCT01923103 - Natural Disease Progress of Dupuytren Disease
Enrolling by invitation NCT03982719 - Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease N/A
Not yet recruiting NCT04907812 - The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery Phase 4
Withdrawn NCT03031080 - BOND Study: the Benefit Of Night Splinting in Dupuytrens' N/A
Completed NCT04874870 - Effectiveness of Splinting After Collagenase Injection Phase 3
Active, not recruiting NCT03407820 - Different Sutures in Hand Surgery N/A
Recruiting NCT03000114 - Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease Phase 4
Recruiting NCT05440240 - Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture Phase 4
Completed NCT03331926 - Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease
Active, not recruiting NCT03741764 - Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device N/A
Completed NCT01876498 - Registry of Patient With M. Dupuytren and Validation of the Brief MHQ N/A
Completed NCT03868449 - Question Prompt List for Common Hand Conditions N/A
Completed NCT03573765 - Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data