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Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Sponsor: Tampere University Hospital
Summary
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.
Official title: TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2020-10-27
Completion Date
2035-03-31
Last Updated
2024-10-09
Healthy Volunteers
No
Conditions
Interventions
Arthroscopic Debridement
Wrist arthroscopy can be performed with or without irrigation. In the debridement arm, a central or radial TFCC tear found during arthroscopy is debrided with a shaver. Portals are closed either with sutures or with medical tape. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.
Placebo surgery
Diagnostic wrist arthroscopy can be performed with or without irrigation. A central or radial TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed either with sutures or with medical tape. The procedure is performed in general or regional anesthesia in operating room. Participants are not able to see to the operation area or monitor. They will listen to music with noise-cancelling headphones throughout the operation. The operative time will be matched, with the surgeon simulating a debridement procedure. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.
Arthroscopic or Open Repair
An ulnar TFCC tear found during wrist arthroscopy is sutured to the capsule or fovea with one of the separately defined methods choosed by the treating hand surgeon. The procedure is performed in general or regional anesthesia in operating room. Wounds are closed and standardized post-operative treatment is started after six weeks.
Physiotherapy
An ulnar TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Physiotherapy exercises of wrist and DRUJ stabilizers is started after two weeks.
Locations (9)
Herlev/Gentofte University Hospital of Copenhagen
Copenhagen, Denmark
Hospital Sønderjylland
Sønderborg, Denmark
Hospital Nova of Central Finland
Jyväskylä, Central Finland, Finland
Oulu University Hospital
Oulu, North Ostrobothnia, Finland
Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland
Karolinska University Hospital
Stockholm, Sweden