Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT05035693
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement from baseline on Neck Disability Index (NDI)', 'timeFrame': 'Baseline and month 24', 'description': 'Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.'}, {'measure': 'Improvement from baseline on Visual Analogue Scales (VAS arm/neck)', 'timeFrame': 'Baseline and month 24', 'description': 'Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Core Outcome Measure Index (COMI neck)', 'timeFrame': 'Baseline and months 24', 'description': 'The clinical results of COMI neck will be compared to the 24 months visit before the operation.'}, {'measure': 'Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)', 'timeFrame': 'Baseline and moths 24', 'description': 'The clinical results of SF-36 will be compared to the 24 months visit before the operation.'}, {'measure': 'Change from baseline in EuroQoL (EQ-5D-5L)', 'timeFrame': 'Baseline and moths 24', 'description': 'The clinical results of (EQ-5D-5L) will be compared to the 24 months visit before the operation.'}, {'measure': 'Change from baseline in Japanese Orthopedic Association Score (JOA)', 'timeFrame': 'Baseline and moths 24', 'description': 'The clinical results of (JOA) will be compared to the 24 months visit before the operation.'}, {'measure': 'Analyse of the Range of Motion (ROM)', 'timeFrame': 'Baseline and moths 24', 'description': 'The radiological results of the ROM are compared to the 24 months visit before the operation.'}, {'measure': 'Monitoring of product related occurence of adverse events (AE-Monitoring)', 'timeFrame': 'Baseline and moths 24', 'description': 'The radiological results of the AE-Monitoring are compared to the 24 months visit before the operation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herniated Disc', 'Cervical Spine', 'Discopathy', 'Radiculopathy'], 'conditions': ['Discopathy', 'Herniated Cervical Disc', 'Stenoses, Spinal', 'Radiculopathy']}, 'descriptionModule': {'briefSummary': 'Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.\n\nObjectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.', 'detailedDescription': "This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,\n2. documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,\n3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,\n4. unsuccessful conservative medical care regarding the indication within the last six weeks,\n5. age ≥18 years,\n6. patient must agree to fully participate in the clinical trial and give informed consent in writing,\n7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),\n8. patient information has been provided and all written consents of the patient are available.\n\nExclusion Criteria:\n\n* Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:\n\n 1. Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,\n 2. active systemic infection or infection at the operative site,\n 3. sustained osteoporotic fracture of the spine, hip or wrist,\n 4. spinal metastases,\n 5. known allergy to titanium or polycarbonate-urethane,\n 6. confirmed pregnancy,\n 7. severe cervical myelopathy,\n 8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),\n 9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),\n 10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level,\n 11. patient is kept in an institution under judicial or official orders (MPG §20.3)."}, 'identificationModule': {'nctId': 'NCT05035693', 'acronym': 'PMCF_MOVE®-C', 'briefTitle': 'Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C', 'organization': {'class': 'INDUSTRY', 'fullName': 'NGMedical GmbH'}, 'officialTitle': '"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics', 'orgStudyIdInfo': {'id': 'P004'}, 'secondaryIdInfos': [{'id': 'DRKS00022971', 'type': 'OTHER', 'domain': 'Deutsches Register Klinischer Studien'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMCF MOVE-C', 'description': 'PMCF MOVE®\\_C is a single arm observational study with 170 patients.', 'interventionNames': ['Device: MOVE®-C']}], 'interventions': [{'name': 'MOVE®-C', 'type': 'DEVICE', 'otherNames': ['cervical disc prothesis'], 'description': 'Momo- or bisegmental implantation of MOVE®-C cervical prothesis.', 'armGroupLabels': ['PMCF MOVE-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1180', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ronald Sabitzer, OA', 'role': 'CONTACT', 'email': 'ronald.sabitzer@gesundheitsverbund.de', 'phone': '0043 6767017974'}], 'facility': 'Wiener Gesundheitsverbund-Klinik Penzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '14050', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Olaf Süss, PD Dr.med.', 'role': 'CONTACT', 'email': 'olaf.suess@drk-kliniken.de', 'phone': '+493030354260'}, {'name': 'Sven Mularski, Dr.med.', 'role': 'CONTACT', 'email': 'sven.mularski@drk-kliniken.de', 'phone': '+493030354260'}, {'name': 'Björn Kühn, Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Langer, Dr.med', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'DRK Klinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '63571', 'city': 'Gelnhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Hölper, Dr. med.', 'role': 'CONTACT', 'email': 'b.hölper@neuro-chirurgie.de'}, {'name': 'Yasmin Mitsikari', 'role': 'CONTACT', 'email': 'y.mitsikari@neuro-chirurgie.de'}], 'facility': 'Wirbelsäulenzentrum Fulda Main, Kinzig', 'geoPoint': {'lat': 50.20164, 'lon': 9.18742}}, {'zip': '25524', 'city': 'Itzehoe', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ardeshir Ardeshiri, Dr. med.', 'role': 'CONTACT', 'email': 'aardeshiri@aol.com', 'phone': '0049- 821-7726702'}, {'name': 'Lisa-Marie Feldhaus', 'role': 'CONTACT', 'email': 'L.Feldhaus@KH-Itzehoe.de', 'phone': '0049- 821-7726702'}], 'facility': 'Medizinisches Versorgungszentrum Steinburg', 'geoPoint': {'lat': 53.92099, 'lon': 9.51529}}, {'zip': '56073', 'city': 'Koblenz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Francis K Kilian, Dr.med.', 'role': 'CONTACT', 'email': 'f.kilian@kk-km.de', 'phone': '0049 261 496-6457'}, {'name': 'Nina Schroeder', 'role': 'CONTACT', 'email': 'n.schroeder@kk-km.de', 'phone': '0049 261 496-6457'}, {'name': 'Bernhard Bruchmann, Dr.med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Katholisches Klinikum Koblenz - Montabaur', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '81669', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ardavan Ardeshiri, Dr. med.', 'role': 'CONTACT', 'email': 'ardeshiri@neurochirurgie-am-gasteig.de', 'phone': '0049 896666339040'}, {'name': 'Jenifer Kilian', 'role': 'CONTACT', 'email': 'jkilian@neurochirurgie-am-gasteig.de', 'phone': '0049 896666339040'}], 'facility': 'Neurochirurgie am Gasteig', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '52146', 'city': 'Würselen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rolf Sobottke, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'rolf.sobottke@rheinmaasklinikum.de', 'phone': '0049 2405623372'}, {'name': 'Khaled Allan', 'role': 'CONTACT', 'email': 'allan.khaled@rheinmaasklinikum.de', 'phone': '0049-2405-62-8258'}], 'facility': 'Rhein-Maas Klinikum Würselen', 'geoPoint': {'lat': 50.81809, 'lon': 6.1347}}], 'centralContacts': [{'name': 'Saskia Mathieu, M.Sc.', 'role': 'CONTACT', 'email': 'smathieu@ngmedical.de', 'phone': '+49687399997118'}, {'name': 'Nino Weiland, B.Sc.', 'role': 'CONTACT', 'email': 'nweiland@ngmedical.de', 'phone': '+49687399997104'}], 'overallOfficials': [{'name': 'Olaf Süss, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRK Kliniken Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be available for other researchers, that will not be a study site in this clinical trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NGMedical GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}