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Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.

Study acronym: PROMPTCohort
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Apr 1, 2028 → Dec 31, 2029
See other at-risk trials from McMaster University

Record History

  1. Notable Primary completion pushed from Apr 1, 2028 to Dec 31, 2029 Start date: Apr 1, 2026 to Jan 1, 2027 · Completion pushed from Aug 1, 2028 to Dec 31, 2029 · Eligibility criteria expanded, about 17 words · 1 more Show 4 more changesShow less
    • Start date: Apr 1, 2026 to Jan 1, 2027
    • Completion pushed from Aug 1, 2028 to Dec 31, 2029
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Minor Study title shortened, about 5 wordsv2 See this version in full on ClinicalTrials.gov ↗
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Each year within Canada and the US, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. Although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.
Trial Details
NCT Number NCT07459777
Lead Sponsor McMaster University
Conditions Shoulder Dislocation
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov