Weight Bearing After Pelvis and Acetabulum Fracture Fixation

NCT07189156 | Not Yet Recruiting DMC

• 1 other identifier: UMMC-IRB-2025-115
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Weight Bearing; Pelvis Fractures; Acetabulum Fractures; Immediate Weight Bearing; Early Weight Bearing

Outcome Measures

Primary Outcomes (4)

• Study enrollment rates of eligible patients

  Target enrollment of 50% of patients (surgeon agreement to enroll patient) and 50% of patients eligible for inclusion to agree to participate in study

  Within 72 hours after surgery

• Clinic follow-up rates for patients enrolled in study

  \>90% target follow-up of patients at 3-month postoperative visit

  3 months

• Correct documentation of randomized weight bearing status in medical charts of patients

  Target 100% correct documentation of assigned weight bearing status in postoperative medical documentation (both in-hospital documentation and during follow-up visits)

  12 months

• Correct documentation of secondary outcome of reoperation in medical documentation

  Target 100% correct documentation of secondary outcome of reoperation in medical documentation during follow-up visits

  12 months

Secondary Outcomes (1)

• Patient reoperation for any reason in the postoperative period

  12 months

Study Arms (2)

Patient who has a pelvis fracture treated operatively

EXPERIMENTAL

Other: Immediate Weight Bearing Pelvis; Other: Delayed Weight Bearing Pelvis

Patient who has an acetabulum fracture treated operatively

EXPERIMENTAL

Other: Immediate Weight Bearing Acetabulum; Other: Delayed Weight Bearing Acetabulum

Interventions

Immediate Weight Bearing Pelvis OTHER

Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.

Patient who has a pelvis fracture treated operatively

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.

Patient who has a pelvis fracture treated operatively

Immediate Weight Bearing Acetabulum OTHER

Patient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.

Patient who has an acetabulum fracture treated operatively

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.

Patient who has an acetabulum fracture treated operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years old and above
• Patients with surgically treated pelvis or acetabulum fractures

You may not qualify if:

• 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
• Pre-injury non-ambulatory status
• Suspected issues with follow-up
• Language barriers precluding obtaining adequate informed consent

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (7)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

R Adams Cowley Shock Trauma Center - University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Inova Medical Group

Fairfax, Virginia, 22031, United States

Location

Vancouver General Hospital - University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (6); CA (1)