Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-10 @ 11:24 PM
Study NCT ID:
NCT07224958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No blinding; all participants and study team are aware of the assigned brace.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized crossover assignment followed by a parallel continuation period. Participants will cross over between the ROAM OA brace and the comparator, then continue in a chosen brace for the remainder of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2025-11-03', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knee adduction moment during gait', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.'}, {'measure': 'Change in Visual Analog Scale (VAS) walking pain', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in KOOS (Knee injury and Osteoarthritis Outcome Score) subscale scores', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Change in scores on the KOOS questionnaire, which includes five subscales: Pain, Symptoms, Activities of Daily Living, Sports/Recreation, and Quality of Life. Each subscale is scored from 0 to 100, where 0 = extreme problems and 100 = no problems. Higher scores indicate better outcomes. Comparisons will be made between baseline, 4 weeks, and 8 weeks.'}, {'measure': 'Change in knee range of motion (ROM)', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Change in knee range of motion (flexion and extension) measured using goniometry; comparisons made between baseline, 4 weeks, and 8 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['knee brace', 'gait analysis'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '22563589', 'type': 'BACKGROUND', 'citation': 'Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.'}, {'pmid': '37244981', 'type': 'BACKGROUND', 'citation': 'Chang J, Yuan Y, Fu M, Wang D. Health-related quality of life among patients with knee osteoarthritis in Guangzhou, China: a multicenter cross-sectional study. Health Qual Life Outcomes. 2023 May 27;21(1):50. doi: 10.1186/s12955-023-02133-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment osteoarthritis. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with osteoarthritis.', 'detailedDescription': "INTRODUCTION The Enovis ROAM OA outcomes study is a prospective, single-center, crossover study with a subsequent randomized control phase and extended follow-up gait analysis, intended to evaluate the efficacy of the ROAM OA knee brace in subjects with medial knee osteoarthritis (OA).\n\nThe purpose of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment OA. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with OA.\n\n1.1 Background Osteoarthritis of the knee significantly impacts the quality of life and functional capacity of those affected. Globally, hundreds of millions of people live with OA, with the knee being the most frequently affected joint. This condition leads to symptoms such as pain, swelling, and stiffness, which impair mobility and daily activities, affecting overall well-being and social connectedness.\n\nThe prevalence of knee OA is influenced by factors such as aging and obesity, and with an aging population, the incidence of knee OA is expected to rise. This increase underscores the need for effective management strategies.\n\nNon-invasive interventions such as knee orthoses have been highlighted in OA management. These devices, including the ROAM OA Single Upright Brace, are designed to unload the affected compartment of the knee to reduce pain and improve function. Despite their potential benefits, the efficacy and biomechanical impacts of these braces require further investigation to optimize their clinical use.\n\nAssessment of health-related quality of life (HRQoL) in patients with knee OA helps quantify disease burden and treatment effectiveness. Instruments such as the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analog Pain Scale (VAS) are commonly used to evaluate impairment and pain, respectively.\n\nAs the prevalence of knee OA continues to increase, there is a clear need for ongoing research into effective management strategies, including orthotic interventions. Understanding the impact of these approaches on quality of life and functional outcomes is essential to guide clinical decision-making.\n\n1.2 Rationale Although several studies have examined knee braces in OA, there remains limited understanding of their specific biomechanical effects and correlation with patient-reported outcomes. The influence of braces on knee adduction moments-a key factor in medial compartment loading and pain-remains insufficiently characterized.\n\nThis study is designed to address that gap by integrating objective gait analysis with patient-reported outcomes. Assessing changes in knee adduction moments and other gait parameters will provide insight into the mechanical effectiveness of the ROAM OA Single Upright Brace. Evaluating patient-reported outcomes such as pain, comfort, and function will clarify how mechanical improvements correspond to perceived clinical benefit.\n\n1.3 Device Description The ROAM OA knee brace, manufactured by Enovis, is intended for individuals with symptoms, physical findings, or radiographic evidence of moderate to severe unicompartmental knee OA, postoperative meniscal repair where unicompartmental unloading is indicated, or varus-valgus conditions that may benefit from compartmental unloading.\n\nIt is a single-patient-use device that alleviates pain due to single-compartment OA by applying controlled forces to the leg to shift load from the affected knee compartment to the healthier one.\n\n1.4 Clinical Data to Date This is the first clinical study to collect prospective data on the ROAM OA knee brace.\n\nSTUDY DESIGN 2.1 Number of Study Sites Subjects will be recruited from Midwest Orthopedics at Rush and all affiliated clinical locations. All study activities will be conducted in the Rush Department of Orthopedic Surgery Motion Analysis Laboratory.\n\n2.2 Number of Subjects Thirty subjects will be enrolled.\n\n2.3 Estimated Study Duration Enrollment is expected at a rate of approximately two subjects per month, with clinical follow-up at four and eight weeks. The total study duration is estimated at 18 months.\n\nSTUDY OBJECTIVES 3.1 Primary Objective Biomechanical Comparison: To compare the immediate and short-term biomechanical effects of the ROAM OA brace and the Ossur Unloader One brace, focusing on knee adduction moments and spatiotemporal gait parameters.\n\nLong-term Efficacy: To evaluate the long-term effectiveness of the ROAM OA brace in improving pain and functional outcomes among individuals with knee OA.\n\n3.2 Secondary Objectives Evaluate safety and comfort of the ROAM OA brace, including any adverse effects and user experience.\n\nAssess changes in gait parameters over time to determine the brace's role in promoting functional mobility and reducing medial knee load.\n\nSTUDY ENDPOINTS 4.1 Primary Endpoints Changes in Knee Adduction Moment: Measured at baseline (no brace), immediately after fitting each brace, and at four- and eight-week follow-ups using markerless gait analysis.\n\nVAS Pain Changes: Pain levels assessed via VAS at each study milestone, including baseline, post-fitting, and follow-ups.\n\n4.2 Secondary Endpoints Brace comfort and user compliance\n\nPain medication usage\n\nKOOS score changes\n\nDevice-related and serious adverse event rate\n\nChanges in spatiotemporal gait parameters (step length, walking speed, cadence)\n\nSTUDY POPULATION 5.1 Eligibility Criteria Inclusion Criteria\n\nAdults aged 40-85 years\n\nBMI \\<35\n\nDiagnosed with medial compartment knee OA\n\nWalking pain ≥4 on the VAS\n\nWillingness to wear the assigned brace daily and complete study follow-up\n\nAbility to walk independently for at least 20 minutes\n\nStable use of over-the-counter pain medications\n\nNo intra-articular injections within three months of enrollment\n\nExclusion Criteria\n\nLateral or patellofemoral OA\n\nPrevious knee joint replacement\n\nLigamentous instability or acute lower extremity injury\n\nNeurological disorders affecting gait\n\nDermatologic or allergic conditions preventing brace use\n\nCurrent use of opioids or corticosteroids\n\nInability to understand study instructions\n\nPregnancy\n\nSTUDY PROCEDURES\n\nAll participants will provide electronic informed consent through a secure platform prior to participation.\n\nSubjects will undergo baseline data collection, brace fitting, crossover gait analysis, and randomized assignment to either brace or standard-of-care control groups. Follow-up assessments will occur at four and eight weeks, including ROM evaluation, PROMs, gait analysis, and safety review.\n\nAll data will be documented on case report forms and securely stored in accordance with institutional requirements.\n\nSubjects will incur no cost for participation. Both braces will be provided for study purposes.\n\nRISK/BENEFIT ASSESSMENT 7.1 Risk Category Low risk.\n\n7.2 Potential Risks Minor risk of falls during walking tests\n\nTemporary muscle soreness\n\nSkin irritation from the brace\n\nFinger strain from adjusting buckles\n\nEmotional discomfort from questionnaires\n\n7.3 Protection Against Risks Participants will be monitored closely, and any protocol deviations required for safety will be reported to the IRB.\n\n7.4 Potential Benefits Participants may experience improved comfort, pain relief, or mobility due to brace use. Data collected may contribute to improved clinical management of knee OA in the future.\n\nSTATISTICAL PLAN\n\nP-values less than 0.05 will be considered statistically significant.\n\n8.1 Primary Analysis Changes in knee adduction moments, gait parameters, and VAS pain scores across defined timepoints will be analyzed using appropriate statistical models for repeated measures.\n\n8.2 Secondary Analysis Secondary endpoints, including KOOS changes, brace comfort, and adverse event rates, will be analyzed descriptively and inferentially as applicable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria:\n* Age 40-85 years.\n* BMI ≤ 35.\n* Physician-diagnosed medial compartment knee osteoarthritis.\n* Visual Analog Scale (VAS) walking pain ≥ 4.\n* Willing to wear assigned brace ≥ 4 hours/day.\n* Able to walk independently for 20 minutes unaided.\n* Stable pain medication regimen ≥ 4 weeks.\n* ≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection.\n\nExclusion Criteria:\n\n* Lateral or patellofemoral osteoarthritis.\n* Prior knee replacement.\n* Significant ligament injury or acute lower limb injury.\n* Neurological condition affecting gait.\n* Severe psychiatric or neurological disorder affecting pain perception.\n* Skin condition or allergy preventing brace use.\n* Current use of another brace or assistive device.\n* Recent opioid or corticosteroid use (\\<4 weeks).\n* Pregnant.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07224958', 'briefTitle': 'ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA', 'orgStudyIdInfo': {'id': '23110204-IRB01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROAM OA brace', 'description': 'Participants receive the ROAM OA Single Upright Knee Brace (Enovis) to wear daily for the study duration. The brace is designed to offload the medial compartment of the knee and improve pain and function.', 'interventionNames': ['Device: ROAM OA Single Upright Knee Brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Unloader brace or standard of care', 'description': 'Participants receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard pain management and physical therapy guidelines. This group serves as an active comparator to the ROAM OA brace.', 'interventionNames': ['Device: Ossur Unloader One Knee Brace or Standard of Care']}], 'interventions': [{'name': 'ROAM OA Single Upright Knee Brace', 'type': 'DEVICE', 'description': 'A commercially available single-upright knee brace designed to offload the medial compartment of the knee in patients with unicompartmental osteoarthritis; manufactured by Enovis. Participants will wear the brace daily for the duration of the study.', 'armGroupLabels': ['ROAM OA brace']}, {'name': 'Ossur Unloader One Knee Brace or Standard of Care', 'type': 'DEVICE', 'description': 'Participants will receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard management and physical therapy guidelines. This group serves as the active comparator to the ROAM OA brace.', 'armGroupLabels': ['Active Comparator: Unloader brace or standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Christopher Knowlton, PhD', 'role': 'CONTACT', 'email': 'christopher_knowlton@rush.edu', 'phone': '312-942-6938'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Markus Wimmer, PhD', 'role': 'CONTACT', 'email': 'markus_a_wimmer@rush.edu', 'phone': '3129422789'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Enovis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Grainger Director of the RUSH Arthritis and Orthopedics Institute', 'investigatorFullName': 'Markus Wimmer', 'investigatorAffiliation': 'Rush University Medical Center'}}}}