Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Akershus

Criteria

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