Anterior Knee PainNCT05428332
Spring Loaded Tri-Compartment Unloader Knee Brace Study
A study testing Tri-Compartment Unloader Brace in people with Anterior Knee Pain, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain
- What is being tested?
- Tri-Compartment Unloader Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Redwood City Outpatient Center
Redwood City, California, 94063
About this study
Official title: Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain
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.
Read the 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
- Being tested
- Tri-Compartment Unloader Brace
- Keywords
- Knee Brace Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-Compartment Unloader BraceDevice
Also called TCU Brace
Knee brace that is designed to reduce compressive forces on all three compartments of the knee.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tri-Compartment Unloader Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6-weeks, and 3-months
Secondary outcomes (6)
Quality of Life (EQ-5D)
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).
Measured: Baseline, 6-weeks, and 3-months
Lower Extremity Activity Scale (LEAS)
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).
Measured: Baseline, 6-weeks, and 3-months
Quadricep Strength (Girth)
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.
Measured: Baseline through 3-months post-intervention
Effusion Grade
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.
Measured: Baseline through 3-months post-intervention
Painful Crepitus With Deep Knee Flexion
Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint.
Measured: Baseline through 3 months post-intervention
Knee Range of Motion
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.
Measured: Baseline through 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start5 Apr 2022
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Knee PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups. One brace (intervention) group and one no brace (control) group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Spring Loaded Tech
- Responsible party
- Principal investigator, Seth Sherman, Stanford University
- Investigators
- Seth L Sherman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428332
- Sponsor's protocol ID
- 62059
- Status last verified
- Nov 2024
- First submitted
- 16 Jun 2022
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT05428332
- Acronym / sponsor ID
- 62059
- Conditions
- Anterior Knee Pain
- Keywords
- Knee Brace Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Spring Loaded Tech
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups. One brace (intervention) group and one no brace (control) group.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Tri-Compartment Unloader Brace50% of the participants in the study that will be receiving a TCU brace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-Compartment Unloader BraceAlso: TCU BraceKnee brace that is designed to reduce compressive forces on all three compartments of the knee. | Device | Tri-Compartment Unloader Brace Group |
Primary outcome
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.
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.
6 secondary outcomes
Quality of Life (EQ-5D)
Time frame: Baseline, 6-weeks, and 3-months
Lower Extremity Activity Scale (LEAS)
Time frame: Baseline, 6-weeks, and 3-months
Quadricep Strength (Girth)
Time frame: Baseline through 3-months post-intervention
Effusion Grade
Time frame: Baseline through 3-months post-intervention
Painful Crepitus With Deep Knee Flexion
Time frame: Baseline through 3 months post-intervention
Knee Range of Motion
Time frame: Baseline through 3 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share data.
Related trials for Anterior Knee Pain
Not yet recruitingPhase 4
Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
Post Operative Swelling
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Enrolling by invitation
Photobiomodultion in Anterior Knee Pain
Anterior Knee Pain, Photobiomodulation (PBM)
RecruitingPhase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
Patellofemoral Pain Syndrome
Not yet recruiting
Bone-Patellar Tendon-Bone Versus Quadriceps Tendon Autograft for Anterior Cruciate Ligament Reconstruction: A Non-Inferiority Trial Regarding Anterior Knee Pain
Anterior Cruciate Ligament (ACL) Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth L Sherman, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-Compartment Unloader Brace in people with Anterior Knee Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 6-weeks, and 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.