Immediate Weightbearing vs Delayed Weightbearing

Enrolling by invitation · Not applicable

Conditions studied: Rehabilitation

In brief

The purpose of this study is to perform a feasibility trial of immediate versus delayed weight bearing following fixation of fractures of the lower extremity, pelvis, and acetabulum. The investigator will enroll patients from Shock Trauma over a period of 12 months, and randomize them to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (non-weightbearing for 6-12 weeks). Four specific feasibility criteria will be assessed: enrollment (target 50%), follow-up (target 90% at 3 months), correct documentation of weight bearing (target 90%), correct documentation of primary outcomes, which include reoperation and hardware failure (target 90%). Target enrollment is patients with fractures where the current standard of care is delayed WBAT; for lower extremity this will include fractures of the distal femur, proximal tibia, and distal tibia, including select fractures with intra-articular extension. If feasibility criteria are met over the course of this study, the investigator hopes to move forward with a multicenter randomized controlled trial on this topic.

Key facts

Study ID

NCT05595148

Run by

University of Maryland, Baltimore

People needed

100

Starts

2023-04-10

Expected to finish

2026-12-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fracture of the acetabulum, pelvis, distal femur, distal tibia, including those with intra- articular extension, that meets surgical indications.
• Operative treatment within 7 days of injury at R Adams Cowley Shock Trauma Center, University of Maryland, University of Maryland Medical System, University of Maryland Capital Region Medical Center.
• Provision of informed consent.

You may not qualify if…

• Non English Speaking.
• Cognitive ability does not allow for full understanding of study procedures ( Patient has been diagnosed with psychiatric condition, intellectually challenged without adequate family support).
• Patient has other orthopaedic or non-orthopaedic injuries that would preclude him/her from being able to weight bear immediately (e.g. open fractures, polytrauma.
• Significant impaction (>2mm) or comminution at joint surface (e.g. with acetabulum, distal femur, tibial plateau, or tibial plafond fractures).
• Patients who would not be able to immediately weight bear or comply with weight bearing restrictions.
• Not willing to be randomized.
• Surgeon or clinical follow will not occur at participating hospital or location.
• Anticipated problems with follow up in the judgement of study personnel ( patient is homeless).

Where it is running

• University of Maryland, Shock Trauma Center — Baltimore, Maryland, United States
• University of Maryland, Capital Region Health — Cheverly, Maryland, United States

Full record on ClinicalTrials.gov

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