Comparing surgical treatments for wrist injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.