Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04528992
Status:
WITHDRAWN
Last Update Posted:
2024-04-23
First Post:
2020-08-18
Brief Title:
Effects of Blood Flow Restriction BFR Therapy on ACL Graft Maturation
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Effects of Blood Flow Restriction BFR Therapy on Early Anterior Cruciate Ligament ACL Graft Maturation
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
BFR Physical Therapy Protocol was not finalized and department had multiple similar studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study comparing the effects of blood flow restriction BFR therapy on the maturation of the Anterior Cruciate Ligament ACL graft after reconstruction surgery compared to physical therapy without the use of BFR
Detailed Description:
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery BFR therapy will begin as early as 2 weeks after surgery The initial 2 weeks after surgery or prior to initiation of BFR will consist of the physical therapy following the surgeons postoperative protocol
To be considered for participation in this study patients must be 18 years and older undergoing primary ACL reconstruction In addition patients must meet several inclusionexclusion criteria to be randomized and included in this study
To be considered for participation in this study patients must be 18 years and older undergoing primary ACL reconstruction In addition patients must meet several inclusionexclusion criteria to be randomized and included in this study
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