Clinical trial NCT05428332: Spring Loaded Tri-Compartment Unloader Knee Brace Study
Official title: Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients with Anterior Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain
Keywords: Knee Brace Effectiveness
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Spring Loaded Tech
First posted: 2022-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. One brace (intervention) group and one no brace (control) group.
Primary purpose: TREATMENT

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 relatednto 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.

Eligibility criteria: Inclusion Criteria:

1. Anterior knee pain that worsens when the knee is flexed and bearing weight
2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
3. Kellgren and Lawrence grade 0-3 of PF joint
4. Able to wear the TCU knee brace for a minimum of 3 hours per day
5. Over 18 years old, can understand written English
6. Coronal knee alignment within 7 degrees of neutral
7. Must be able to fit within an off-the-shelf knee brace size provided by Company
8. Must complete physical therapy through Stanford

Exclusion Criteria:

1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
2. Use of another brace designed to unload the knee or manage knee pain during the study
3. Varus/Valgus joint alignment \> 7 degrees
4. Inability to be fit properly in an off-the-shelf brace provided by the Company
5. BMI \>40
6. Bilateral knee symptoms

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Visual Analog Scale (VAS)
timeFrame: Baseline; 6-weeks and 3-months post-intervention
Secondary outcomes:
measure: Quality of life (EQ-5D)
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Lower Extremity Activity Scale (LEAS)
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Quadricep strength (girth)
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Effusion grade
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Painful crepitus with deep knee flexion
timeFrame: Baseline; 6-weeks and 3-months post-intervention
measure: Knee range of motion
timeFrame: Baseline; 6-weeks and 3-months post-intervention
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Redwood City Outpatient Center
state: California
Study officials:
affiliation: Stanford University
name: Seth L Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: