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Restoring Anatomy of Ruptured Achilles Tendon

Study acronym: RATAR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jan 15, 2025 to Feb 28, 2025
    • Site contacts updated at 1 of 3 sites
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 3 of 3 sites
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation . We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.
Trial Details
NCT Number NCT06723639
Lead Sponsor Bispebjerg Hospital
Collaborators: Copenhagen University Hospital, Hvidovre, Sahlgrenska University Hospital
Conditions
(from sponsor)		 Achilles Tendon Rupture
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov