Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

The trial is a multicentre, randomized, superiority, controlled, participant and outcome assessor (debridement versus placebo surgery randomization cohort) and trialist blinded (both arms) superiority, umbrella trial with two randomized cohorts (1. debridement or placebo surgery, 2. repair or physiotherapy) which both include two 1:1 parallel arms. The primary objective is to investigate the superiority of 1) debridement over placebo surgery and 2) repair over physiotherapy in two randomized cohorts using Patient-Rated Wrist Evaluation (PRWE) at one year post randomisation as the primary outcome.

NCT Number	NCT04576169
Lead Sponsor	Tampere University Hospital Collaborators: Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Karolinska Institutet, Hospital Sønderjylland, Copenhagen University Hospital at Herlev, Hospital Nova, Central Finland
Conditions	Triangular Fibrocartilage Complex Injury
Enrollment	204 participants
Start Date	2020-10-27
Primary Completion	2028-03-31 (estimated)
Study Completion	2035-03-31 (estimated)
Updated on ClinicalTrials.gov	2024-10-09