Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-04 @ 2:48 PM
Study NCT ID:
NCT06118892
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MISHA Post-Market Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from device- and procedure-related Subsequent Surgical Interventions', 'timeFrame': '5 years post-implantation'}], 'secondaryOutcomes': [{'measure': 'WOMAC Pain', 'timeFrame': '5 years', 'description': 'Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of pain. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.'}, {'measure': 'WOMAC Function', 'timeFrame': '5 years', 'description': 'Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline).\n\nWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of function. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'Prospective evaluation of the safety and effectiveness of the MISHA Knee System.\n\nThe study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.\n\nThe primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.\n\nThis study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.\n\nStudy subjects will be followed over a five-year post-implant period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subjects aged 25 to 65 years at time of index procedure\n2. Body Mass Index (BMI) of \\< 35\n3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature\n4. WOMAC pain ≥ 40\n5. Failed non-operative OA treatment\n\nKey Exclusion Criteria:\n\n1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device\n2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)\n3. Ligamentous instability\n4. Active or recent knee infection\n5. Inflammatory joint disease, including sequalae of viral infections\n6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals\n7. History of keloid, hypertrophic or contracture scaring\n8. Propensity for restrictive scar formation or adhesions with prior procedures'}, 'identificationModule': {'nctId': 'NCT06118892', 'briefTitle': 'MISHA Post-Market Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Moximed'}, 'officialTitle': 'Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CP0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MISHA Knee System', 'interventionNames': ['Device: MISHA Knee System']}], 'interventions': [{'name': 'MISHA Knee System', 'type': 'DEVICE', 'otherNames': ['Implantable Shock Absorber (ISA)'], 'description': 'The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.', 'armGroupLabels': ['MISHA Knee System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dennis Crawford, MD', 'role': 'CONTACT'}, {'name': 'Dennis Crawford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Samantha Raphael, PA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Diduch, MD', 'role': 'CONTACT'}, {'name': 'David Diduch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Rose Weinstein', 'role': 'CONTACT', 'email': 'rsweinstein@moximed.com', 'phone': '5108873375'}, {'name': 'Vijaya Krishnamoorthy', 'role': 'CONTACT', 'email': 'vkrishnamoorthy@moximed.com', 'phone': '5108873328'}], 'overallOfficials': [{'name': 'Dennis Crawford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moximed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}