Actively Recruiting
Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Led by Tampere University Hospital · Updated on 2024-10-09
204
Participants Needed
9
Research Sites
752 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Gross instability of DRUJ defined as obvious instability in all forearm and wrist positions
- Distal (Palmer 1C) TFCC tear found 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 affecting radio- or ulnocarpal or DRUJ
- Lunotriquetral instability diagnosed in arthroscopy
- ECU instability
- Massive tear with degenerated edges or frayed tear which cannot be sutured (Atzei class 4A-4B)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Herlev/Gentofte University Hospital of Copenhagen
Copenhagen, Denmark, 2900
Actively Recruiting
2
Hospital Sønderjylland
Sønderborg, Denmark
Actively Recruiting
3
Hospital Nova of Central Finland
Jyväskylä, Central Finland, Finland, 40620
Actively Recruiting
4
Oulu University Hospital
Oulu, North Ostrobothnia, Finland, 90220
Actively Recruiting
5
Kuopio University Hospital
Kuopio, Northern Savonia, Finland, 70029
Actively Recruiting
6
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33521
Actively Recruiting
7
Turku University Hospital
Turku, Southwest Finland, Finland, 20521
Actively Recruiting
8
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
9
Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
Research Team
V
Ville M Mattila, M.D., Ph.D., Professor
CONTACT
J
Jarkko Jokihaara, M.D., Ph.D., Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here