Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
Tampere University Hospital
204 participants
Oct 27, 2020
INTERVENTIONAL
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
Inclusion Criteria6
- Ulnar sided wrist pain
- Age more than 18 years
- Suspicion of TFCC tear in clinical examination
- Ability to fill the Danish, Finnish or Swedish versions of questionnaires
- Symptom duration more than 3 months, and unsuccessful non-operative treatment
- Central (Palmer 1A), ulnar (Palmer 1B) or radial (Palmer 1D) TFCC tear explaining the pain in arthroscopy
Exclusion Criteria9
- Gross instability of DRUJ which will be defined as "obvious instability in clinical examination in each forearm and wrist position"
- Distal (Palmer 1C) TFCC tear in arthroscopy
- Ulnocarpal or DRUJ arthrosis (Atzei class 5)
- Ulnar variance ≥ +2 mm in x-ray
- Age above 65 years
- Rheumatoid arthritis or other inflammatory disease effecting radio- or ulnocarpal or DRUJ
- Lunotriquetral instability diagnosed in arthroscopy
- ECU instability
- Massive tear and degenerated edges or frayed tear which fails suture (Atzei class 4A-4B)
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Interventions
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.
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.
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.
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)
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NCT04576169