Pelvis FracturesNCT07189156
Weight Bearing After Pelvis and Acetabulum Fracture Fixation
A study testing Immediate Weight Bearing Pelvis, Delayed Weight Bearing Pelvis and Immediate Weight Bearing Acetabulum in people with Pelvis Fractures and Acetabulum Fractures, run by University of Mississippi Medical Center at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvis Fractures, Acetabulum Fractures
- What is being tested?
- Immediate Weight Bearing Pelvis, Delayed Weight Bearing Pelvis and Immediate Weight Bearing Acetabulum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years old and above
- Patients with surgically treated pelvis or acetabulum fractures
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States6 sites
R Adams Cowley Shock Trauma Center - University of Maryland
Baltimore, Maryland, 21201
Casey Loudermilk, 410-706-0935, cloudermilk@som.umaryland.edu
Robert O'Toole, MD
University of Alabama Birmingham
Birmingham, Alabama, 35233
Thomas Frazier, 205.641.0824, thomasfrazier@uabmc.edu
Clay Spitler, MD
Arrowhead Regional Medical Center
Colton, California, 92324
Mikayla Kricfalusi, 877-873-2762, mikayla.kricfalusi@md.cusm.edu
Joseph Elsissy, MD
Inova Medical Group
Fairfax, Virginia, 22031
Grace Phillips, 571-472-6464, grace.phillips@inova.org
Greg Gaski, MD
Indiana University Health
Indianapolis, Indiana, 46202
Lauren Hill, hilllc@iu.edu
Dillon O'Neill, MD
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Caesar Alshibli, MD, 6018153066, calshibli@umc.edu
Peter Mittwede, MD, PhD
Canada1 site
Vancouver General Hospital - University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Chloe Chong, 604-875-5239, chloe.chong@vch.ca
Aresh Sepehri, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvis Fractures, Acetabulum Fractures
- Being tested
- Immediate Weight Bearing Pelvis, Delayed Weight Bearing Pelvis, Immediate Weight Bearing Acetabulum, Delayed Weight Bearing Acetabulum
- Keywords
- Weight Bearing, Pelvis Fractures, Acetabulum Fractures, Immediate Weight Bearing, Early Weight Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Weight Bearing PelvisOther
Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.
Delayed Weight Bearing PelvisOther
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 AcetabulumOther
Patient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.
Delayed Weight Bearing AcetabulumOther
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 group | Role | What they receive |
|---|---|---|
| Patient who has a pelvis fracture treated operatively | Experimental | Not described Receives: Other: Immediate Weight Bearing Pelvis; Other: Delayed Weight Bearing Pelvis |
| Patient who has an acetabulum fracture treated operatively | Experimental | Not described Receives: Other: Immediate Weight Bearing Acetabulum; Other: Delayed Weight Bearing Acetabulum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 12 months
Secondary outcomes (1)
Patient reoperation for any reason in the postoperative period
Track number of all-cause reoperations in all patients in medical documentation postoperatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Mittwede, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189156
- Sponsor's protocol ID
- UMMC-IRB-2025-115
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Weight Bearing After Fixation of Pelvis and Acetabulum Fractures: A Multicenter Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07189156
- Acronym / sponsor ID
- UMMC-IRB-2025-115
- Conditions
- Pelvis Fractures, Acetabulum Fractures
- Keywords
- Weight Bearing, Pelvis Fractures, Acetabulum Fractures, Immediate Weight Bearing, Early Weight Bearing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years old and above
- Patients with surgically treated pelvis or acetabulum fractures
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Weight Bearing PelvisPatient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery. | Other | Patient who has a pelvis fracture treated operatively |
| Delayed Weight Bearing PelvisPatient 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 | Patient who has a pelvis fracture treated operatively |
| Immediate Weight Bearing AcetabulumPatient with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery. | Other | Patient who has an acetabulum fracture treated operatively |
| Delayed Weight Bearing AcetabulumPatient 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. | Other | Patient who has an acetabulum fracture treated operatively |
Primary outcome
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
Clinic follow-up rates for patients enrolled in study
Time frame: 3 months
>90% target follow-up of patients at 3-month postoperative visit
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)
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
1 secondary outcome
Patient reoperation for any reason in the postoperative period
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Weight Bearing Pelvis, Delayed Weight Bearing Pelvis and Immediate Weight Bearing Acetabulum in people with Pelvis Fractures and Acetabulum Fractures, run by University of Mississippi Medical Center at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study enrollment rates of eligible patients (time frame: Within 72 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.