Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05595148
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2022-10-10
Brief Title:
Immediate Weightbearing vs Delayed Weightbearing
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Randomized Feasibility Trial for Immediate vs Delayed Weightbearing for Surgically Treated Fractures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Weight bearing restrictions are increasingly being scrutinized as understanding of the potential negative effects of immobilization expand Recent studies have highlighted that early WBAT may be safe following fixation of lower extremity pelvis and acetabulum fractures where the standard of care has been delayed WBAT but high-quality prospective studies on this topic are needed
The investigator hypothesizes that in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation this trial will
1 be able to enroll 50 of eligible patients and have a 90 follow-up at 90 days post-op of enrolled patients
2 be able to achieve 90 correct documentation of postoperative weight bearing status and primary outcomes reoperation or hardware failure
Specific Aim 1 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation whether 50 of patients can be enrolled and 90 of those enrolled will have 90-day follow-up
Specific Aim 2 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation whether 90 correct documentation of postoperative weight bearing status and 90 correct documentation of primary outcomes reoperation or hardware failure can be obtained
The investigator anticipates that the feasibility criteria will be met with regard to enrollment follow-up and documentation which will allow us to begin a likely multicenter randomized controlled trial evaluating early versus delayed weight bearing following lower extremity pelvis and acetabulum fixation
The investigator hypothesizes that in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation this trial will
1 be able to enroll 50 of eligible patients and have a 90 follow-up at 90 days post-op of enrolled patients
2 be able to achieve 90 correct documentation of postoperative weight bearing status and primary outcomes reoperation or hardware failure
Specific Aim 1 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation whether 50 of patients can be enrolled and 90 of those enrolled will have 90-day follow-up
Specific Aim 2 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity pelvis and acetabulum fracture fixation whether 90 correct documentation of postoperative weight bearing status and 90 correct documentation of primary outcomes reoperation or hardware failure can be obtained
The investigator anticipates that the feasibility criteria will be met with regard to enrollment follow-up and documentation which will allow us to begin a likely multicenter randomized controlled trial evaluating early versus delayed weight bearing following lower extremity pelvis and acetabulum fixation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None