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Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Study acronym: REINFORCER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Mar 31, 2027 to Mar 31, 2028v6 Show 7 more changesShow less
    • Enrollment target: 160 to 204
    • Study completion date: Mar 31, 2027 to Mar 31, 2035
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 81 words
    • Study sites revised (9)
    • Collaborators: 5 to 8
  2. Secondary endpoints revised (6)v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2020 to Oct 27, 2020
    • Site details revised at 9 of 9 sites
    v3
  5. Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 2 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04576169
Lead Sponsor Tampere University Hospital
Collaborators: Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Karolinska Institutet, Hospital Sønderjylland, Copenhagen University Hospital at Herlev, Hospital Nova, Central Finland
Conditions
(from sponsor)		 Triangular Fibrocartilage Complex Injury
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov