Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Patient-Rated Wrist Evaluation (PRWE) — 10 year follow-up, primary time point at 1 year
  The PRWE questionnaire is a wrist-specific instrument comprising a 15-item questionnaire assessing pain and disability in daily living. PRWE provides a score ranging from 0 (best) to 100 (worst). This wrist-specific tool demonstrates good reliability, validity, and responsiveness. Translation and validation have been conducted for Danish, Finnish, and Swedish languages. In interpreting the results, we will employ the Minimally Important Difference (MID) value of 14. PRWE as secondary outcome will be measured at all the other time points (6 months, 2, 5 and 10 years) than primary outcome.

Trial sites (9)

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