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 Overview
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Brief Summary
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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
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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

Conditions
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Spine Surgery

Intervention / Treatment
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* Device: Solera™ Medtronic
* Device: CD HORIZON BalanC™ Medtronic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PLIF<br>The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). | Device: Solera™ Medtronic<br>* The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic<br>|
| Other: Hybrid system (PLIF + flexible pedicle screw system above the<br>The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. | Device: CD HORIZON BalanC™ Medtronic<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the subscores of physical pain and physical function in the ODI Questionaire |  | Baseline to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCS and individual dimensions and subscales of the SF-36™ |  | 60 Month |