Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT04489394
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quintex® Follow-up After One Year Minimum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Results measured by Neck Disability Index (NDI)', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.'}], 'secondaryOutcomes': [{'measure': 'Neck and arm pain', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'Visual analogue scale for pain: The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale:\n\nvery satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)'}, {'measure': 'Quality of life measured by EQ-5D-5L', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': "The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state."}, {'measure': 'Dysphagia assessment', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none'}, {'measure': 'Complications', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'Adverse Events and Serious Adverse Events, reoperations and revisions rates'}, {'measure': 'Postoperative Need for Pain medication', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': "The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder"}, {'measure': 'Radiological outcome from standard x-rays', 'timeFrame': 'One retrospective visit, between one and approx. five years post-op.', 'description': 'Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Spondylolisthesis', 'Trauma', 'Spinal Stenosis', 'Deformity of Spine', 'Pseudoarthrosis of Spine', 'Cervical Spondylosis', 'Instability; Back']}, 'referencesModule': {'references': [{'pmid': '37842541', 'type': 'RESULT', 'citation': 'Bruchmann B, Kilian F. Follow-up of a new titanium cervical plate for fusion of the cervical spine. Orthop Rev (Pavia). 2023 Oct 12;15:84651. doi: 10.52965/001c.84651. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center\n\nExclusion Criteria:\n\n* Patient informed consent not signed\n* Patients living outside a radius of 80 km around the study center'}, 'identificationModule': {'nctId': 'NCT04489394', 'acronym': 'Quintex', 'briefTitle': 'Quintex® Follow-up After One Year Minimum', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year', 'orgStudyIdInfo': {'id': 'AAG-O-H-1901'}}, 'contactsLocationsModule': {'locations': [{'zip': '56073', 'city': 'Koblenz', 'country': 'Germany', 'facility': 'Katholisches Klinikum Koblenz', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}