NCT05595148

Immediate Weightbearing vs Delayed Weightbearing

Randomized Feasibility Trial for Immediate vs Delayed Weightbearing for Surgically Treated Fractures
University of Maryland, Baltimore·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Rehabilitation
Drug/Device/Intervention
Immediate WBAT
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
University of Maryland, Baltimore
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2023
End date
Oct 01, 2024
Enrollment
100 participants
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
Care involving use of rehabilitation proceduresDrug rehabilitationCare involving use of other rehabilitation proceduresCare involving use of rehabilitation procedure, unspecifiedPersonal history of rehabilitation measures
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05595148
Type
Non-Device Trial
About this record

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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