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Weight Bearing After Pelvis and Acetabulum Fracture Fixation

ConditionsPelvis FracturesAcetabulum Fractures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Mississippi Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years old and above

Patients with surgically treated pelvis or acetabulum fractures

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate Weight Bearing Pelvis

    Other intervention

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

  • Delayed Weight Bearing Pelvis

    Other intervention

    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 intervention

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

  • Delayed Weight Bearing Acetabulum

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Patient who has a pelvis fracture treated operativelyExperimental treatment 2 interventions
Group B: Patient who has an acetabulum fracture treated operativelyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

Clinic follow-up rates for patients enrolled in study

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

Time frame
3 months
3

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
4

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

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Mississippi Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: