NCT04576169 Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
| NCT ID | NCT04576169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Triangular Fibrocartilage Complex Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2020-10-27 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2020-10-27 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Antti Kaivorinne, M.D.
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT04576169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Triangular Fibrocartilage Complex Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04576169 currently recruiting?
Yes, NCT04576169 is actively recruiting participants. Contact the research team at ville.mattila@tuni.fi for enrollment information.
Where is the NCT04576169 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Sønderborg, Denmark, Jyväskylä, Finland, Oulu, Finland and 5 additional locations.
Who is sponsoring the NCT04576169 clinical trial?
NCT04576169 is sponsored by Tampere University Hospital. The principal investigator is Antti Kaivorinne, M.D. at Tampere University Hospital. The trial plans to enroll 204 participants.