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Completed

NCT Number: NCT05428332

Spring Loaded Tri-Compartment Unloader Knee Brace Study

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.

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Key information

Conditions

Anterior Knee Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Redwood City Outpatient Center

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tri-Compartment Unloader Brace

Device

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

Other names: TCU Brace

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline, 6-weeks, and 3-months

    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.

  2. Pain Visual Analog Scale (VAS)

    Time frame: Baseline, 6-weeks, and 3-months

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

Secondary outcomes

  1. Quality of Life (EQ-5D)

    Time frame: Baseline, 6-weeks, and 3-months

    Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems. The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are then scaled to a score of 0 to 100 (high scores correspond to higher health related quality of life).

  2. Lower Extremity Activity Scale (LEAS)

    Time frame: Baseline, 6-weeks, and 3-months

    Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients answer 20 questions, choosing from 18 options of activity levels (0 = no activity, to 18 = college/professional athlete level of activity). Individual scores are summed and averaged to create the overall score (range: 0 to 18, with highest scores corresponding to highest level of activity).

  3. Quadricep Strength (Girth)

    Time frame: Baseline through 3-months post-intervention

    Using a biodex to measure quadriceps strength. Number of participants achieving a minimal clinically important difference (MCID) in quadriceps strength, defined as a greater than or equal to 10% increase from baseline.

  4. Effusion Grade

    Time frame: Baseline through 3-months post-intervention

    Number of participants with effusion, by grade. Checking how much fluid is around the knee. There are different grades, ranging from Grade 1 to Grade 5. Grade 1 means no fluid-wave while performing a downward stroke whereas Grade 5 means excess of fluid that makes it impossible to stroke the medial fluid away.

  5. Painful Crepitus With Deep Knee Flexion

    Time frame: Baseline through 3 months post-intervention

    Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint.

  6. Knee Range of Motion

    Time frame: Baseline through 3 months post-intervention

    Number of participants with full or deficient range of motion (ROM). Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg. Deficient ROM is nonzero at full extension and/or < 130° flexion. Full ROM is defined as 0° extension and 130° flexion.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Spring Loaded Tech

Registry information

Official study title

Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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