Immediate Versus Delayed Weight Bearing After Fixation of Pelvis and Acetabulum Fractures: A Multicenter Feasibility Randomized Controlled Trial
University of Mississippi Medical Center
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.
Description
Early weight bearing is frequently allowed and encouraged following fixation of hip and femoral and tibial shaft fractures, while periarticular and pelvis and acetabulum fractures are often prescribed 6-12 weeks of restricted weight bearing. Early weight bearing has been shown to be associated with a number of benefits following fixation of various lower extremity fractures, and delayed weight bearing is associated with an increased risk of medical complications and delayed improvement in functional outcomes. The risks associated with delayed weight bearing have encouraged clinicians to consid…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults 18 years old and above 2. Patients with surgically treated pelvis or acetabulum fractures Exclusion Criteria: 1. Presence of fractures to the ipsilateral or contralateral lower extremity that would preclude WBAT on the surgically repaired pelvis/acetabulum fracture 2. Presence of upper extremity injury that would limit weight bearing using an assistive device such as a walker or crutches 3. Severe injuries to other body systems that would prevent patient from being able to comply with weight bearing protocol 4. Presence of significant psychiatric or cognitive d…
Interventions
- OtherImmediate Weight Bearing Pelvis
Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.
- OtherDelayed 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.
- OtherImmediate Weight Bearing Acetabulum
Patient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.
- OtherDelayed 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.
Locations (7)
- University of Alabama BirminghamBirmingham, Alabama
- Arrowhead Regional Medical CenterColton, California
- Indiana University HealthIndianapolis, Indiana
- R Adams Cowley Shock Trauma Center - University of MarylandBaltimore, Maryland
- University of Mississippi Medical CenterJackson, Mississippi
- Inova Medical GroupFairfax, Virginia