Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Triangular Fibrocartilage Complex Injury

In brief

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.

Key facts

Study ID

NCT04576169

Run by

Tampere University Hospital

People needed

204

Starts

2020-10-27

Expected to finish

2035-03-31

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 it is running

• Herlev/Gentofte University Hospital of Copenhagen — Copenhagen, Denmark (enrolling)
• Hospital Sønderjylland — Sønderborg, Denmark (enrolling)
• Hospital Nova of Central Finland — Jyväskylä, Central Finland, Finland (enrolling)
• Oulu University Hospital — Oulu, North Ostrobothnia, Finland (enrolling)
• Kuopio University Hospital — Kuopio, Northern Savonia, Finland (enrolling)
• Tampere University Hospital — Tampere, Pirkanmaa, Finland (enrolling)
• Turku University Hospital — Turku, Southwest Finland, Finland (enrolling)
• Helsinki University Hospital — Helsinki, Uusimaa, Finland (enrolling)
• Karolinska University Hospital — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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