Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03404232
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the health-related outcome measurement instruments (ODI)', 'timeFrame': '24-48 months'}, {'measure': 'Changes in the health-related outcome measurement instruments (COMI)', 'timeFrame': '24-48 months'}, {'measure': 'Changes in the health-related outcome measurement instruments (SF-36)', 'timeFrame': '24-48 months'}, {'measure': 'Radiological outcomes', 'timeFrame': '24-48 months', 'description': 'Radiological changes within the adjacent segment'}], 'secondaryOutcomes': [{'measure': 'Device complication (breakage, loosening, etc.)', 'timeFrame': '24 - 48 months', 'description': 'Complication regarding the device'}, {'measure': 'Patient-related complication', 'timeFrame': '24- 48 months', 'description': 'general and surgical complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spine Surgery']}, 'referencesModule': {'references': [{'pmid': '30016956', 'type': 'DERIVED', 'citation': 'Herren C, Sobottke R, Pishnamaz M, Scheyerer MJ, Bredow J, Westermann L, Berger EM, Oikonomidis S, Eysel P, Siewe J. The use of the DTO hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial. BMC Musculoskelet Disord. 2018 Jun 21;19(1):199. doi: 10.1186/s12891-018-2103-x.'}]}, 'descriptionModule': {'briefSummary': 'The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.', 'detailedDescription': 'Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).\n\nPlanned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Legal capacity\n* Age ≥ 18 years\n* Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III or spondylolisthesis Meyerding grades I-III.\n* Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability\n\nExclusion Criteria:\n\n* Motor deficit\n* Cauda equina syndrome\n* Previous surgical intervention of the lumbar spine\n* Relevant peripheral neuropathy\n* Acute denervation subsequent to a radiculopathy\n* Scoliosis with Cobb angle greater than 25°\n* Spondylolisthesis \\> Meyerding grade III\n* Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)\n* No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)\n* Radiologic signs of degeneration in the adjacent segment of the intended fusion with \\>Fujiwara grade II or \\>Pfirrmann grade IV\n* Signs of instability in any lumbar spine segment other than that undergoing fusion\n* General contraindication for elective lumbar spine surgery\n* Pathologic fracture\n* Osteoporosis with pathologic fracture\n* Active systemic infection\n* Rheumatic disease\n* Disease of bone metabolism (e.g. Paget\'s Disease)\n* Bone metastasis\n* Local infection focus lumbar spine\n* Seizure disorder\n* Chronic ischemia Fontaine classification IIb-IV\n* Severe heart insufficiency (NYHA III-IV)\n* Blood coagulation disorder or blood thinning therapy\n* Cortisone intake more than one month in the last 12 months before randomization\n* Simultaneous participation in another clinical trial in the 30 days before randomization\n* Known allergy or intolerance to the implants\n* Dependency on investigator\n* Lack of familiarity with the German language\n* Placement in an institution by governmental or juridical advice\n* Absent legal capacity\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03404232', 'briefTitle': 'Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Aachen'}, 'officialTitle': 'The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'UKKuUKA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.).', 'interventionNames': ['Device: Dynesys DTO device (Zimmer Spine, Inc.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.).', 'interventionNames': ['Device: Dynesys DTO device (Zimmer Spine, Inc.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.).', 'interventionNames': ['Device: Dynesys DTO device (Zimmer Spine, Inc.)']}], 'interventions': [{'name': 'Dynesys DTO device (Zimmer Spine, Inc.)', 'type': 'DEVICE', 'description': 'All patients receive posterior hybrid instrumentation.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Aachen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Herren', 'investigatorAffiliation': 'University Hospital, Aachen'}}}}