Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-19 @ 8:21 AM
Study NCT ID:
NCT05428332
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spring Loaded Tri-Compartment Unloader Knee Brace Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allenseo@stanford.edu', 'phone': '9254939732', 'title': 'Allen Seo', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.91', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '72.59', 'spread': '15.72', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.17', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '85.99', 'spread': '16.60', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.39', 'spread': '11.19', 'groupId': 'OG000'}, {'value': '86.76', 'spread': '13.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at the respective time point'}, {'type': 'PRIMARY', 'title': 'Pain Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'spread': '0', 'groupId': 'OG000'}, {'value': '36.17', 'spread': '23.37', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.61', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '8.42', 'spread': '10.48', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.33', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '17.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': 'Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Quality of Life (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '12.76', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.83', 'spread': '14.32', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '32.99', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.8', 'spread': '12.89', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '26.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Lower Extremity Activity Scale (LEAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '12', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '11.25', 'spread': '4.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Quadricep Strength (Girth)', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Using a biodex to measure quad strength.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Effusion Grade', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Checking how much fluid is around the knee. There are different grades. 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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Painful Crepitus With Deep Knee Flexion', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Painful crepitus is when there is a sensation or noise when you move a joint.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Knee Range of Motion', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: TCU bracing', 'description': 'Participants will be instructed to wear a tricompartment offloader (TCU) knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '20 participants signed informed consent, and 14 were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: TCU Bracing', 'description': 'Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants will undergo standard of care rehabilitation protocol only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-28', 'size': 143311, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-26T13:37', 'hasProtocol': True}, {'date': '2022-06-28', 'size': 104640, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-10T12:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No one will be masked/blinded in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups. One brace (intervention) group and one no brace (control) group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2022-06-16', 'resultsFirstSubmitDate': '2025-11-05', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-05', 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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.'}, {'measure': 'Pain Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': 'Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (EQ-5D)', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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).'}, {'measure': 'Lower Extremity Activity Scale (LEAS)', 'timeFrame': 'Baseline, 6-weeks, and 3-months', 'description': '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).'}, {'measure': 'Quadricep Strength (Girth)', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Using a biodex to measure quad strength.'}, {'measure': 'Effusion Grade', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Checking how much fluid is around the knee. There are different grades. 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.'}, {'measure': 'Painful Crepitus With Deep Knee Flexion', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Painful crepitus is when there is a sensation or noise when you move a joint.'}, {'measure': 'Knee Range of Motion', 'timeFrame': 'Baseline; 6-weeks and 3-months post-intervention', 'description': 'Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Knee Brace Effectiveness'], 'conditions': ['Anterior Knee Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.\n\nThese 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Anterior knee pain that worsens when the knee is flexed and bearing weight\n2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI\n3. Kellgren and Lawrence grade 0-3 of PF joint\n4. Able to wear the TCU knee brace for a minimum of 3 hours per day\n5. Over 18 years old, can understand written English\n6. Coronal knee alignment within 7 degrees of neutral\n7. Must be able to fit within an off-the-shelf knee brace size provided by Company\n8. Must complete physical therapy through Stanford\n\nExclusion Criteria:\n\n1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year\n2. Use of another brace designed to unload the knee or manage knee pain during the study\n3. Varus/Valgus joint alignment \\> 7 degrees\n4. Inability to be fit properly in an off-the-shelf brace provided by the Company\n5. BMI \\>40\n6. Bilateral knee symptoms'}, 'identificationModule': {'nctId': 'NCT05428332', 'briefTitle': 'Spring Loaded Tri-Compartment Unloader Knee Brace Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Examining the Efficacy of a Tri-Compartment Unloader Knee Brace During Physical Rehabilitation in Non-Surgical Patients With Anterior Knee Pain', 'orgStudyIdInfo': {'id': '62059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Brace Group', 'description': '50% of the participants in the study that will not be receiving a TCU brace.'}, {'type': 'EXPERIMENTAL', 'label': 'Tri-Compartment Unloader Brace Group', 'description': '50% of the participants in the study that will be receiving a TCU brace.', 'interventionNames': ['Device: Tri-Compartment Unloader Brace']}], 'interventions': [{'name': 'Tri-Compartment Unloader Brace', 'type': 'DEVICE', 'otherNames': ['TCU Brace'], 'description': 'Knee brace that is designed to reduce compressive forces on all three compartments of the knee.', 'armGroupLabels': ['Tri-Compartment Unloader Brace Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Redwood City Outpatient Center', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Seth L Sherman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spring Loaded Tech', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopaedic Surgery', 'investigatorFullName': 'Seth Sherman', 'investigatorAffiliation': 'Stanford University'}}}}