Spring Loaded Tri-Compartment Unloader Knee Brace Study

NCT05428332 | Completed Results FDA Device

• 1 other identifier: 62059
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Knee Pain

Keywords

Knee Brace Effectiveness

Outcome Measures

Primary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

  Baseline, 6-weeks, and 3-months

• Pain Visual Analog Scale (VAS)

  Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.

  Baseline, 6-weeks, and 3-months

Secondary Outcomes (6)

• Quality of Life (EQ-5D)

  Baseline, 6-weeks, and 3-months

• Lower Extremity Activity Scale (LEAS)

  Baseline, 6-weeks, and 3-months

• Quadricep Strength (Girth)

  Baseline through 3-months post-intervention

• Effusion Grade

  Baseline through 3-months post-intervention

• Painful Crepitus With Deep Knee Flexion

  Baseline through 3 months post-intervention

Study Arms (2)

No Brace Group

NO INTERVENTION

50% of the participants in the study that will not be receiving a TCU brace.

Tri-Compartment Unloader Brace Group

EXPERIMENTAL

50% of the participants in the study that will be receiving a TCU brace.

Device: Tri-Compartment Unloader Brace

Interventions

Tri-Compartment Unloader Brace DEVICE

Knee brace that is designed to reduce compressive forces on all three compartments of the knee.

Also known as: TCU Brace

Tri-Compartment Unloader Brace Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Spring Loaded Tech: collaborator

Study Sites (1)

Stanford Redwood City Outpatient Center

Redwood City, California, 94063, United States

Location

Results Point of Contact

• Title: Allen Seo
• Organization: Stanford University

allenseo@stanford.edu

9254939732

Study Officials

• Seth L Sherman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No one will be masked/blinded in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Model Details: Two groups. One brace (intervention) group and one no brace (control) group.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 23, 2022
• Study Start: April 5, 2022
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: May 5, 2026
• Results First Posted: November 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)