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Weight-bearing of Surgically Treated Acetabular Fractures.

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Feb 2021 to May 2024
    • Secondary endpoints: details revised at 4 of 4 entries
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively. Both study groups are stratified according to * Type of fracture (anterior approach vs anterior + additional posterior approach) * Dislocated dome vs non-dislocated/ non existing separate dome fragment Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.
Trial Details
NCT Number NCT04724811
Lead Sponsor Hospital District of Helsinki and Uusimaa
Conditions
(from sponsor)		 Acetabular Fracture
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov