Weight Bearing After Pelvis and Acetabulum Fracture Fixation

Conditions

• Acetabulum Fractures
• Pelvis Fractures

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Immediate Weight Bearing Pelvis — OTHER
  Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.
• Delayed Weight Bearing Pelvis — OTHER
  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.
• Immediate Weight Bearing Acetabulum — OTHER
  Patient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.
• Delayed Weight Bearing Acetabulum — OTHER
  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.

Study Details

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.

Key Dates

Start date

Oct 31, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patient who has a pelvis fracture treated operatively
• Experimental: Patient who has an acetabulum fracture treated operatively

Primary Outcome Measure

Study enrollment rates of eligible patients [ Time Frame: Within 72 hours after surgery ]

Locations (6)

Find similar trials in Birmingham, AL