Weight Bearing After Pelvis and Acetabulum Fracture Fixation
NCT07189156 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-09-23
Summary
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.
Conditions
- Pelvis Fractures
- Acetabulum Fractures
Interventions
- OTHER
-
Immediate Weight Bearing Pelvis
Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.
- OTHER
-
Delayed Weight Bearing Pelvis
Patient with a pelvis fracture may be randomized to be delayed weight bearing as tolerated (either non-weight bearing, foot flat, or toe touch weight bearing per surgeon discretion) for 6-12 weeks after surgery.
- OTHER
-
Immediate Weight Bearing Acetabulum
Patient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.
- OTHER
-
Delayed Weight Bearing Acetabulum
Patient with an acetabulum fracture may be randomized to be delayed weight bearing as tolerated (either non-weight bearing, foot flat, or toe touch weight bearing per surgeon discretion) for 6-12 weeks after surgery.
Sponsors & Collaborators
-
University of Mississippi Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-31
Countries
- United States
- Canada
Study Locations
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