Weight Bearing After Pelvis and Acetabulum Fracture Fixation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Mississippi Medical Center
About this trial
The goal of this study to determine if a randomized clinical trial of immediate versus delayed weight bearing after undergoing surgical fixation of a pelvis or acetabulum fracture is feasible. The main questions it aims to answer are:
Are surgeons willing to allow inclusion of their patients into such a trial? Are patients willing to participate in such a trial? Will patients be compliant with assigned weight bearing status in such a trial? Can good patient follow-up be obtained in such a trial? Is participation in such a trial safe?
Patients from 7 medical centers will be enrolled, and randomized to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (for 6-12 weeks). Feasibility metrics revolving around enrollment, follow-up, and documentation will be monitored, as well as medical and surgical complications. This pilot study will help inform feasibility and design of a larger definitive multicenter randomized controlled trial (RCT) on this topic.
Eligibility criteria
Qualifiers
Adults 18 years old and above
Patients with surgically treated pelvis or acetabulum fractures
Disqualifiers
Presence of fractures to the ipsilateral or contralateral lower extremity that would preclude WBAT on the surgically repaired pelvis/acetabulum fracture
Presence of upper extremity injury that would limit weight bearing using an assistive device such as a walker or crutches
Severe injuries to other body systems that would prevent patient from being able to comply with weight bearing protocol
Presence of significant psychiatric or cognitive disorder or disability that would prevent patient from being able to comply with weight bearing protocol
Trial design
Treatments tested in this trial
- Immediate Weight Bearing Pelvis
- Delayed Weight Bearing Pelvis
- Immediate Weight Bearing Acetabulum
- Delayed Weight Bearing Acetabulum
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov