Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-24 @ 11:22 PM
Study NCT ID:
NCT02926404
Status:
TERMINATED
Last Update Posted:
2023-12-07
First Post:
2016-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UNiD Rods Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 743}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Early terminated for administrative reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological performance compared to planning', 'timeFrame': '12 months', 'description': 'The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to:\n\n* Sagittal vertical axis (SVA)\n* Lumbar Lordosis (LL)\n* Thoracic Kyphosis (TK)\n* Pelvic Tilt (PT)\n* Pelvic Incidence (PI)\n* Sacral Slope (SS)\n* Cobb Angle (CA)'}], 'secondaryOutcomes': [{'measure': 'Postoperative spinal alignment', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Evaluation of the deformity correction in the sagittal and/or coronal plan. The primary objective is to compare the preoperative sagittal parameters with those obtained postoperatively including but not limited to:\n\nSagittal vertical axis (SVA) Lumbar Lordosis (LL) Thoracic Kyphosis (TK) Pelvic Tilt (PT) Pelvic Incidence (PI) Sacral Slope (SS) Cobb Angle (CA)'}, {'measure': 'Diasbility', 'timeFrame': '3, 6, 12, 24 months', 'description': "To assess patients' disability through the ODI questionnaire"}, {'measure': 'Quality of life/ SRS-22', 'timeFrame': '3, 6, 12, 24 months', 'description': "To assess patients' quality of life through the SRS-22 questionnaire"}, {'measure': "Patients' satisfaction", 'timeFrame': '3, 6, 12, 24 months', 'description': 'Using a satisfaction questionnaire'}, {'measure': 'Adverse event', 'timeFrame': '3, 6, 12, 24 months', 'description': 'To quantify and describe adverse events'}, {'measure': 'Revision', 'timeFrame': '3, 6, 12, 24 months', 'description': 'To quantify and describe surgical revisions'}, {'measure': 'Pain/VAS', 'timeFrame': '3, 6, 12, 24 months', 'description': "To assess patients' pain according to VAS : to 0 (better) to 10 (worst)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sagittal alignment', 'Surgical planning', 'Patient-specific', 'Adult Spinal Deformity'], 'conditions': ['Idiopathic Scoliosis', 'Spinal Curvatures', 'Spondylolisthesis', 'Degenerative Scoliosis']}, 'descriptionModule': {'briefSummary': 'Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).\n\nThis study aims to assess performance, clinical outcomes and safety', 'detailedDescription': 'Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used.\n\nPatient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.\n\nBeside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.\n\nA European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with spinal deformities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL\n* Patient affiliated to health care insurance (social security in France)\n* Patient able to complete a self-administered questionnaire\n* Patient able to sign a disclosure form or a non-opposition form\n\nExclusion Criteria:\n\n* Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL\n* Pregnant patient\n* Patient not affiliated to health care insurance (social security in France)\n* Patient unable to sign a disclosure form\n* Patient unable to complete a self-administered questionnaire'}, 'identificationModule': {'nctId': 'NCT02926404', 'briefTitle': 'UNiD Rods Register', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicrea International'}, 'officialTitle': 'Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register', 'orgStudyIdInfo': {'id': '1501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients operated with Patient-specific rods', 'description': 'Patients with patient-specific rods (UNiD Rods) \\<18Years old', 'interventionNames': ['Device: UNiD Rods']}, {'label': 'Adult patients operated with Patient-specific rods', 'description': 'Patients with patient-specific rods (UNiD Rods) \\>18Years old', 'interventionNames': ['Device: UNiD Rods']}], 'interventions': [{'name': 'UNiD Rods', 'type': 'DEVICE', 'otherNames': ['Patient Specific Rods'], 'description': 'Spinal osteosynthesis', 'armGroupLabels': ['Adult patients operated with Patient-specific rods', 'Pediatric patients operated with Patient-specific rods']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tournai', 'country': 'Belgium', 'facility': 'CH WAPI', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bruges', 'country': 'France', 'facility': 'Orthopôle', 'geoPoint': {'lat': 44.88287, 'lon': -0.61222}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Lomme', 'country': 'France', 'facility': 'Hopital Saint Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Orthopédique Santy', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Les Massues', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hopital la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hopitaux pediatriques - CHU Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'La pitié Salepetrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Saint Etienne Hospital', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Tarnów', 'country': 'Poland', 'facility': 'Pr Andrzej Maciejczak', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}], 'overallOfficials': [{'name': 'Vincent Fiere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Orthopédique Santy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicrea International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}