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

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.

Timeline

Start

2013-10

Primary completion

2022-04

Completion

2022-04

Drugs

Indications