Immediate Weightbearing vs Delayed Weightbearing - Trial NCT05595148
Access comprehensive clinical trial information for NCT05595148 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Maryland, Baltimore and is currently Not yet recruiting. The study focuses on Rehabilitation. Target enrollment is 100 participants.
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Study Focus
Sponsor & Location
University of Maryland, Baltimore
Timeline & Enrollment
N/A
Jan 01, 2023
Oct 01, 2024
Primary Outcome
The number of participants with unplanned reoperation or hardware failure
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05595148
Non-Device Trial