Comparing surgical treatments for wrist injuries
TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
This study tests different surgical options for treating wrist injuries to see which one helps people with wrist pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 9 sites (Copenhagen and 8 other locations) |
| Trial ID | NCT04576169 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of different surgical strategies for treating triangular fibrocartilage complex (TFCC) injuries, which are a common cause of ulnar wrist pain. It is a multicenter, randomized, controlled trial that compares arthroscopic debridement to placebo surgery and TFCC repair to physiotherapy. Participants will be randomly assigned to one of the treatment options, and their outcomes will be assessed using the Patient-Rated Wrist Evaluation at one year post-randomization. The study aims to provide robust evidence on the best treatment approaches for these injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with ulnar-sided wrist pain and a suspected TFCC tear that has not improved with non-operative treatment.
Not a fit: Patients with gross instability of the distal radioulnar joint or significant degenerative changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from TFCC injuries, potentially reducing pain and enhancing wrist function.
How similar studies have performed: Previous observational studies have shown improvements in symptoms after TFCC repair, but this is one of the first randomized controlled trials to rigorously assess the efficacy of these surgical interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Copenhagen and 8 other locations
- Herlev/Gentofte University Hospital of Copenhagen — Copenhagen, Denmark (Recruiting)
- Hospital Sønderjylland — Sønderborg, Denmark (Recruiting)
- Hospital Nova of Central Finland — Jyväskylä, Central Finland, Finland (Recruiting)
- Oulu University Hospital — Oulu, North Ostrobothnia, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Northern Savonia, Finland (Recruiting)
- Tampere University Hospital — Tampere, Pirkanmaa, Finland (Recruiting)
- Turku University Hospital — Turku, Southwest Finland, Finland (Recruiting)
- Helsinki University Hospital — Helsinki, Uusimaa, Finland (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Antti Kaivorinne, M.D. — Tampere University Hospital
- Study coordinator: Ville M Mattila, M.D., Ph.D., Professor
- Email: ville.mattila@tuni.fi
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.