Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT00868335
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2009-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-20', 'studyFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2009-03-23', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Order of movement', 'timeFrame': 'baseline, 3 months, 12 months'}, {'measure': 'Segmental mobility', 'timeFrame': 'Baseline, 3 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Treatment of symptoms (pain, neurological assessment)', 'timeFrame': 'Baseline, 3 months, 12 months'}, {'measure': 'Influence on subjects functioning (social, work)', 'timeFrame': 'Baseline, 3 months, 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical degenerative disc disease', 'Anterior cervical discectomy', 'Cervical disc prosthesis', 'Activ-C', 'Mobility', 'Movement'], 'conditions': ['Diskectomy', 'Intervertebral Disk Displacement']}, 'referencesModule': {'references': [{'pmid': '25887569', 'type': 'DERIVED', 'citation': 'Boselie TF, van Mameren H, de Bie RA, van Santbrink H. Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT. BMC Musculoskelet Disord. 2015 Feb 21;16:34. doi: 10.1186/s12891-015-0479-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.', 'detailedDescription': 'Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases.\n\nAdjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.\n\nKeeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.\n\nWe hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* indication for anterior cervical discectomy\n* monoradicular syndrome caused by compression at C5-6 or C6-7\n* monosegmental disease on MRI\n* able to actively perform flexion/extension movement\n* segmental mobility on the afflicted level \\>2 degrees of rotation\n* informed consent\n\nExclusion Criteria:\n\n* previous operative interventions on the cervical spine\n* multiple segments afflicted\n* positive L'Hermittes sing\n* Active infection\n* Immature bone\n* Tumorous processes in the cervical region\n* Previous radiation therapy in the cervical region\n* Pregnancy\n* Cervical myelopathy\n* not able to speak Dutch"}, 'identificationModule': {'nctId': 'NCT00868335', 'briefTitle': 'Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.', 'orgStudyIdInfo': {'id': 'CWK-Tracking01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Anterior cervical discectomy, no disc prosthesis', 'interventionNames': ['Procedure: Anterior cervical discectomy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Anterior cervical discectomy, with disc prosthesis', 'interventionNames': ['Device: Activ C disc prosthesis', 'Procedure: Anterior cervical discectomy']}], 'interventions': [{'name': 'Activ C disc prosthesis', 'type': 'DEVICE', 'otherNames': ['Activ C cervical disc prosthesis, B.Braun/Aesculap Spine'], 'description': 'cervical disc prosthesis', 'armGroupLabels': ['2']}, {'name': 'Anterior cervical discectomy', 'type': 'PROCEDURE', 'description': 'Removal of protruding cervical disc through an anterior approach', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'H van Santbrink, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'B. Braun/Aesculap Spine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Toon Boselie', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}