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Two-layer Suturing of Achilles Tendon Ruptures

Study acronym: ATRBFH
StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated September 27, 2024 (before its estimated February 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2023 to May 23, 2023
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493). The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial
Trial Details
NCT Number NCT05717270
Lead Sponsor Bispebjerg Hospital
Conditions
(from sponsor)		 Achilles Tendon Rupture
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov