Spring Loaded Tri-Compartment Unloader Knee Brace Study

NCT ID: NCT05428332

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2024-11-05

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.

Conditions

Anterior Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Brace Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tri-Compartment Unloader Brace Group

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

Group Type: EXPERIMENTAL

Tri-Compartment Unloader Brace

Intervention Type: DEVICE

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

Interventions

Tri-Compartment Unloader Brace

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

Intervention Type: DEVICE

Other Intervention Names

TCU Brace

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spring Loaded Tech

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Seth Sherman

Associate Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth L Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Redwood City Outpatient Center

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

62059

Identifier Type: -

Identifier Source: org_study_id