"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
NCT ID: NCT02551302
Last Updated: 2015-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-10-31
2017-12-31
Brief Summary
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Detailed Description
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Control:
Posterior spondylodesis and monosegmental intervertebral cage
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PLIF
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF).
Solera™ Medtronic
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
Hybrid system (PLIF + flexible pedicle screw system above the
The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion.
CD HORIZON BalanC™ Medtronic
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:
CD HORIZON BalanC™ Medtronic
Interventions
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Solera™ Medtronic
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
CD HORIZON BalanC™ Medtronic
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:
CD HORIZON BalanC™ Medtronic
Eligibility Criteria
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Inclusion Criteria
* Legal capacity
* Age ≥ 30 years
* 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.
* Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with \>Fujiwara grade II \[15\] or \>Pfirrmann grade IV \[14\]
* Signs of instability in any lumbar spine segment other than that undergoing fusion
* General contraindication for elective lumbar spine surgery
* Pathologic fracture
* Osteoporosis with pathologic fracture
* Active systemic infection
* Rheumatic disease
* Disease of bone metabolism (e.g. Paget's Disease)
* Bone metastasis
* Local infection focus lumbar spine
* Seizure disorder
* Chronic ischemia Fontaine classification IIb-IV
* Severe heart insufficiency (NYHA III-IV)
* Blood coagulation disorder or blood thinning therapy
* Cortisone intake more than one month in the last 12 months before randomization
* Simultaneous participation in another clinical trial in the 30 days before randomization
* Known allergy or intolerance to the implants
* Dependency on investigator
* Lack of familiarity with the German language
* Placement in an institution by governmental or juridical advice
* Absent legal capacity
* Pregnancy
Exclusion Criteria
* Cauda equina syndrome
* Previous surgical intervention of the lumbar spine
* Relevant peripheral neuropathy
* Acute denervation subsequent to a radiculopathy
* Scoliosis with Cobb angle greater than 25°
* Spondylolisthesis \> Meyerding grade III
30 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University of Cologne
OTHER
Responsible Party
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Dr. Jan Siewe
Dr.med.
Principal Investigators
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Jan Siewe, Dr.med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Cologne
Central Contacts
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Other Identifiers
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Ortho-6-2015
Identifier Type: -
Identifier Source: org_study_id
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