Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 3:02 PM
Study NCT ID:
NCT02551302
Status:
UNKNOWN
Last Update Posted:
2015-09-16
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the subscores of physical pain and physical function in the ODI Questionaire', 'timeFrame': 'Baseline to 6 month'}], 'secondaryOutcomes': [{'measure': 'MCS and individual dimensions and subscales of the SF-36™', 'timeFrame': '60 Month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)', 'detailedDescription': 'Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)\n\nControl:\n\nPosterior spondylodesis and monosegmental intervertebral cage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Legal capacity\n* Age ≥ 30 years\n* Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III \\[20\\]\\[21\\]\\[22\\] 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 \\[15\\] or \\>Pfirrmann grade IV \\[14\\]\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': 'NCT02551302', 'acronym': 'BalanC', 'briefTitle': '"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'orgStudyIdInfo': {'id': 'Ortho-6-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PLIF', 'description': 'The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF).', 'interventionNames': ['Device: Solera™ Medtronic']}, {'type': 'OTHER', 'label': 'Hybrid system (PLIF + flexible pedicle screw system above the', 'description': 'The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion.', 'interventionNames': ['Device: CD HORIZON BalanC™ Medtronic']}], 'interventions': [{'name': 'Solera™ Medtronic', 'type': 'DEVICE', 'description': 'The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic', 'armGroupLabels': ['PLIF']}, {'name': 'CD HORIZON BalanC™ Medtronic', 'type': 'DEVICE', 'description': 'The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed with the following devices:\n\nCD HORIZON BalanC™ Medtronic', 'armGroupLabels': ['Hybrid system (PLIF + flexible pedicle screw system above the']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jan Siewe, Dr.med.', 'role': 'CONTACT', 'email': 'jan.siewe@uk-koeln.de', 'phone': '+49(0)221-478-87294'}, {'name': 'Margarete Wicharz', 'role': 'CONTACT', 'email': 'margarete.wicharz@uk-koeln.de', 'phone': '+49(0)221-478-87294'}], 'overallOfficials': [{'name': 'Jan Siewe, Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.', 'investigatorFullName': 'Dr. Jan Siewe', 'investigatorAffiliation': 'University of Cologne'}}}}