Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 5:25 AM
Study NCT ID:
NCT05428332
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain
Status:
COMPLETED
Status Verified Date:
2024-11
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:
This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes related to pain and function.
Detailed Description:
Patients in this study have been identified as good candidates by their physicians. As the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. The study was designed to present the least risk possible consistent with sound research design.
Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford.
These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.
Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford.
These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: