Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-01 @ 4:40 PM
Study NCT ID:
NCT04296903
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2020-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
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', 'interventionModelDescription': 'Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance of major Cobb angle ≤ 40° 5 years post-surgery', 'timeFrame': '5 years', 'description': 'Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': "The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;\n* Cobb angle between 35-60 degrees (inclusive);\n* Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;\n* Kyphosis angles of ≤ 55 degrees measured from T5 to T12;\n* Appropriate candidate for posterior surgical approach;\n* Patient has good general health;\n* Patient has no known hypersensitivity or allergies to titanium;\n* Patient's guardian signs a written informed consent form (ICF).\n\nExclusion Criteria:\n\n* Any type of non-idiopathic scoliosis;\n* Any main thoracic deformity that includes vertebral levels and cranial including to T2;\n* Known history of existing malignancy, or any systemic or local infection;\n* Spinal cord abnormalities that require treatment;\n* Known neurological deficit (defined as motor grade \\< 5/5);\n* Known poor bone quality defined as T score -1.5 or less;\n* For female Patient, pregnancy;\n* Previous spine surgery that would prevent the successful performance of the MID-C system ;\n* Active systemic disease, such as AIDS, HIV, or active infection;\n* Active infection or the skin is compromised at the surgical site;\n* Systemic disease that would affect the Patient's welfare or overall outcome of the study."}, 'identificationModule': {'nctId': 'NCT04296903', 'briefTitle': 'Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apifix'}, 'officialTitle': 'Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)', 'orgStudyIdInfo': {'id': 'MID-C-AIS-03-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MID-C treatment', 'interventionNames': ['Device: MID-C System']}], 'interventions': [{'name': 'MID-C System', 'type': 'DEVICE', 'description': 'Minimal invasive deformity correction system for the treatment of AIS', 'armGroupLabels': ['MID-C treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Wolfson children's hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30060', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Health", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Univ. of Mississippi Medical Center (UMMC)', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': "Women and Children's Hospital - University of Missouri Health Care", 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Shriners Hospitals for Children', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rainbow babies and children', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': "Dayton Children's Hospital", 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Health', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apifix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}