Immediate Weightbearing vs Delayed Weightbearing
- Disease/Condition
- Rehabilitation
- Drug/Device/Intervention
- Immediate WBAT
- Study type
- Interventional
- Intervention type
- procedure
- Primary sponsor
- University of Maryland, Baltimore
- Phase
- N/A
- Start date
- Jan 01, 2023
- End date
- Oct 01, 2024
- Enrollment
- 100 participants
The number of participants with unplanned reoperation or hardware failure
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05595148
- Type
- Non-Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.