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Search / Trial NCT04576169

Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Launched by TAMPERE UNIVERSITY HOSPITAL · Sep 29, 2020

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Arthroscopy Surgery Triangular Fibrocartilage Randomized Controlled Trial Placebo Repair Wrist Debridement

ClinConnect Summary

This clinical trial is looking at different treatment options for people with a specific wrist injury called a Triangular Fibrocartilage Complex (TFCC) tear. The main goal is to see if a procedure called debridement (which removes damaged tissue) is better than a placebo surgery (a fake surgery) and whether repairing the tear is more effective than physical therapy. Participants will be followed for one year after their treatment to evaluate their wrist function using a special questionnaire.

To join the study, participants need to be at least 18 years old and have had wrist pain on the ulnar side (the side closer to the little finger) for more than three months without improvement from other treatments. They should also be suspected of having a TFCC tear based on a doctor’s examination. However, individuals with certain conditions, such as severe instability of the wrist joint or specific types of TFCC tears, cannot participate. If you choose to be part of this trial, you will be randomly assigned to one of the treatment groups, and your health and recovery will be closely monitored throughout the year.

Gender

ALL

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)

About Tampere University Hospital

Tampere University Hospital (TAYS) is a leading academic medical center in Finland, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, TAYS integrates cutting-edge medical practices with rigorous scientific investigation, focusing on improving patient outcomes and enhancing treatment modalities across various specialties. The hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to foster a multidisciplinary approach to medical research, ensuring that findings are translated into real-world applications for the benefit of patients and the broader healthcare community.

Locations

Stockholm, , Sweden

Helsinki, , Finland

Tampere, , Finland

Stockholm, , Sweden

Turku, , Finland

Helsinki, Uusimaa, Finland

Tampere, Pirkanmaa, Finland

Turku, Varsinais Suomi, Finland

Oulu, Pohjois Pohjanmaa, Finland

Kuopio, Pohjois Savo, Finland

Grålum, , Norway

Copenhagen, , Denmark

Jyväskylä, Keski Suomi, Finland

Copenhagen, , Denmark

Sønderborg, , Denmark

Jyväskylä, Keski Suomi, Finland

Patients applied

0 patients applied

Trial Officials

Antti Kaivorinne, M.D.

Principal Investigator

Tampere University Hospital

Mikko P Räisänen, M.D.

Principal Investigator

Tampere University Hospital

Teemu Karjalainen, M.D., Ph.D.

Principal Investigator

Hospital Nova of Central Finland

Aleksi Reito, M.D., Ph.D., Adjunct professor

Principal Investigator

Tampere University Hospital

Robert Gvozdenovic, M.D., Ph. D.

Principal Investigator

Herlev/Gentofte University Hospital of Copenhagen

Maria Wilcke, M.D., Ph.D.

Principal Investigator

Karolinska Institutet

Turkka Anttila, M.D.

Principal Investigator

Helsinki University Central Hospital

Annele Pönkkö, M.D.

Principal Investigator

Oulu University Hospital

Jerzy Stiasny, M.D.

Principal Investigator

Hospital Sønderjylland

Tuukka Tanskanen, M.D.

Principal Investigator

Turku University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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