Weight Bearing After Pelvis and Acetabulum Fracture Fixation

September 16, 2025 updated by: Peter Mittwede, University of Mississippi Medical Center

Immediate Versus Delayed Weight Bearing After Fixation of Pelvis and Acetabulum Fractures: A Multicenter Feasibility Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 consider the safety of early weight bearing after fixation of various lower extremity fractures.

Retrospective studies have shown low rates of hardware failure with early weight bearing following fixation of fractures for which early WBAT has not traditionally been allowed, including fractures of the pelvis, acetabulum, distal femur, proximal tibia, and distal tibia. Randomized controlled trials with ankle and distal femur fractures have shown no difference in rates of early hardware failure between early and delayed weight bearing. However, high-quality studies in pelvis and acetabulum are lacking.

A definitive RCT on early versus delayed WBAT after fixation of pelvis and acetabulum fractures is necessary, and this would focus on important outcomes such as surgical and medical complications, patient-reported functional status, and timing of return to work or activities of daily living. However, a pilot trial of adequate size is needed to highlight 1) if participant enrollment is feasible (from a surgeon and patient perspective), and 2) if appropriate follow-up and compliance with documentation can be achieved. A pilot trial would also help establish the safety of such a trial, as perioperative complications would be monitored.

The completion of this pilot trial will assist with the design and implementation of a definitive RCT that will compare patient-relevant outcomes of immediate versus delayed WBAT following fixation of pelvis and acetabulum fractures.

RESEARCH QUESTION Is a randomized controlled trial (RCT) of immediate versus delayed weight bearing following fixation of fractures of the pelvis and acetabulum feasible?

SCIENTIFIC AIMS The proposed feasibility trial will address the paucity of high-quality data regarding the safety and feasibility of early weight bearing following fixation of pelvis and acetabulum fractures. A high amount of variability exists with these fractures with regard to the severity of bony, soft tissue, and non-orthopaedic injuries, so our feasibility criteria include: 1) 25% overall patient enrollment (with surgeon and patient agreement to participate in 50% of eligible cases each), 2) >90% follow-up at 3 months), 3) 100% correct documentation of weight bearing status, and 4) 100% correct documentation of primary outcome of reoperation.

HYPOTHESIS The investigators hypothesize that the feasibility criteria will be met, and that this pilot study will inform the design and implementation of a definitive RCT on this topic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital - University of British Columbia
        • Contact:
        • Principal Investigator:
          • Aresh Sepehri, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
        • Principal Investigator:
          • Clay Spitler, MD
        • Contact:
    • California
      • Colton, California, United States, 92324
        • Arrowhead Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Elsissy, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
        • Contact:
        • Principal Investigator:
          • Dillon O'Neill, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • R Adams Cowley Shock Trauma Center - University of Maryland
        • Contact:
        • Principal Investigator:
          • Robert O'Toole, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Peter Mittwede, MD, PhD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Medical Group
        • Principal Investigator:
          • Greg Gaski, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 disorder or disability that would prevent patient from being able to comply with weight bearing protocol
  5. Pre-injury non-ambulatory status
  6. Suspected issues with follow-up
  7. Language barriers precluding obtaining adequate informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient who has a pelvis fracture treated operatively
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.
Experimental: Patient who has an acetabulum fracture treated operatively
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study enrollment rates of eligible patients
Time Frame: Within 72 hours after surgery
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
Time Frame: 3 months
>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
Time Frame: 12 months
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
Time Frame: 12 months
Target 100% correct documentation of secondary outcome of reoperation in medical documentation during follow-up visits
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reoperation for any reason in the postoperative period
Time Frame: 12 months
Track number of all-cause reoperations in all patients in medical documentation postoperatively
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMMC-IRB-2025-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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