Clinical trial NCT02551302: "Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spine Surgery
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2015-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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™)

Detailed description: Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)

Control:

Posterior spondylodesis and monosegmental intervertebral cage

Eligibility criteria: Inclusion Criteria:

* Informed consent
* 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

Exclusion Criteria:

* Motor deficit
* 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
* Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
* No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
* 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

Primary outcomes:
measure: Changes in the subscores of physical pain and physical function in the ODI Questionaire
timeFrame: Baseline to 6 month
Secondary outcomes:
measure: MCS and individual dimensions and subscales of the SF-36™
timeFrame: 60 Month
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Cologne
name: Jan Siewe, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: