Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT02924506
Status:
TERMINATED
Last Update Posted:
2019-05-07
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'Moving of coordinator.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Pain and Disability Scale (NPDS) between the two groups', 'timeFrame': 'Baseline'}, {'measure': 'Neck Pain and Disability Scale (NPDS) between the two groups', 'timeFrame': '3 months'}, {'measure': 'Neck Pain and Disability Scale (NPDS) between the two groups', 'timeFrame': '1 year'}, {'measure': 'Neck Pain and Disability Scale (NPDS) between the two groups', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical arthroplasty'], 'conditions': ['Neck Pain', 'Back Pain']}, 'descriptionModule': {'briefSummary': 'Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.\n\nThe goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-7.\n* Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table\n* Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine\n* NPDS (Neck Pain and Disability Scale) \\> 30\n* Failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment\n* Physical and mental fitness to ensure compliance with the protocol\n* Signed informed consent\n\nExclusion Criteria:\n\n* Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine\n* Paget\'s disease, osteomalacia, other metabolic bone diseases\n* Chronic corticosteroid use\n* Active tumor pathology\n* Segmental angulation \\< -11 ° or \\> 11 ° at the respective segment or adjacent segments on static images of the cervical spine\n* Known allergy to Chromium, Cobalt, Mobdylene (chemical element), Polyethylene, or Titanium\n* History of surgery in the previous 30 days before inclusion\n* History of mental illness or disability involving a "safeguard procedure justice of the person"\n* Contraindications to non steroidal anti inflammatory'}, 'identificationModule': {'nctId': 'NCT02924506', 'acronym': 'DISC-C', 'briefTitle': 'Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term', 'orgStudyIdInfo': {'id': 'CHRO-2014-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fixed Core', 'description': 'Cervical arthroplasty with fixed core prothesis', 'interventionNames': ['Device: ProDisc-C prothesis']}, {'type': 'OTHER', 'label': 'Movable Core', 'description': 'Cervical arthroplasty with movable core prothesis', 'interventionNames': ['Device: Mobi-C prothesis']}], 'interventions': [{'name': 'Mobi-C prothesis', 'type': 'DEVICE', 'description': 'Mobi-C Prothesis, LDR Medical (company)', 'armGroupLabels': ['Movable Core']}, {'name': 'ProDisc-C prothesis', 'type': 'DEVICE', 'description': 'ProDisc-C prothesis, Vivo Depuy Synthes (company)', 'armGroupLabels': ['Fixed Core']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "CHR d'ORLEANS", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Hôpital Bretonneau, CHU DE TOURS', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Thierry DUFOUR, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHR d'Orleans"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}