An interventional study of Immediate Weight Bearing Pelvis and Delayed Weight Bearing Pelvis in Pelvis Fractures and Acetabulum Fractures, sponsored by University of Mississippi Medical Center. Not yet recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Treatment
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.
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.
University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Immediate Weight Bearing Pelvis · Other: Delayed Weight Bearing Pelvis
Other: Immediate Weight Bearing Acetabulum · Other: Delayed Weight Bearing Acetabulum
Patient with a pelvis fracture may be randomized to be immediately weight bearing as tolerated after surgery.
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 with an acetabulum fracture may be randomized to be immediately weight bearing as tolerated after surgery.
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 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 12 months
Patient reoperation for any reason in the postoperative period
Track number of all-cause reoperations in all patients in medical documentation postoperatively
Time frame: 12 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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