Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

  • STATUS
    Recruiting
  • End date
    Mar 31, 2027
  • participants needed
    160
  • sponsor
    Tampere University Hospital
Updated on 6 September 2021

Summary

Trial is a prospective, randomized, controlled, outcome assessor and participant (in other randomization cohort of the trial) blinded, two randomization cohorts, which each has two parallel 1:1 arms, a multinational and -centre trial comparing the efficacy of 1) debridement with placebo surgery and 2) repair with physiotherapy. The primary objective is to compare efficacy of surgery, depending on the type of injury, with either placebo surgery or physiotherapy in 1-year follow-up in two randomization cohorts.

Description

Triangular fibrocartilage complex (TFCC) injuries are often considered the cause of ulnar wrist pain. TFCC lesions can be traumatic or degenerative according to classification suggested by Palmer and Atzei. Primary treatment is conservative, but if symptoms persist, operative treatment is an option. Depending on the morphology of the tear, the treatment can be either debridement or repair. Trialists have observed improvement of symptoms after TFCC repair but all these trials are observational cohorts without proper controls. Efficacy of surgery has not been studied in randomized controlled trial (RCT) setting.

The investigators planned a prospective, randomized, controlled, outcome assessor and participant (in other randomization cohort of the trial) blinded, two randomization cohorts, which each has two parallel 1:1 arms, a multinational and -centre trial comparing the efficacy of 1) debridement with placebo surgery and 2) repair with physiotherapy.

Institutional Review Board (IRB) of Tampere university hospital has approved the study protocol. All participants will give written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.

Outcome measures for different studies are often derived from what clinicians, rather than patients, thinks to be important. The investigators chose to base the efficacy assessment on the measure of patient's subjective disability and pain.

There is no clear evidence of the efficacy of the treatments (debridement and repair). It is justified and ethically correct to compare these treatments to placebo surgery and physiotherapy. Placebo surgery and physiotherapy are less invasive than debridement and repair and because of this are even safer to patients than comparable treatments.

Details
Condition Triangular Fibrocartilage Complex Injury
Treatment Physiotherapy, Arthroscopic Debridement, Placebo surgery, Arthroscopic or Open Repair
Clinical Study IdentifierNCT04576169
SponsorTampere University Hospital
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ulnar sided wrist pain
age more than 18 years
suspicion of TFCC tear in clinical examination (MRI optional)
ability to fill the Danish, Finnish, Norwegian or Swedish versions of questionnaires
symptom duration more than 3 months, and unsuccessful conservative treatment
central, radial or ulnar tear explaining the pain in arthroscopy

Exclusion Criteria

unstable DRUJ which will be defined as "sign of complete instability in clinical examination
distal TFCC tear in arthroscopy
ulnocarpal or DRUJ arthrosis
ulnar variance +2 mm in x-rays
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
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