"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"

Not Applicable

• Conditions: Spine Surgery
• Interventions: Device: CD HORIZON BalanC™ Medtronic; Device: Solera™ Medtronic

• Registration Number: NCT02551302
• Lead Sponsor: University of Cologne

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

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Study Start: 2015-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid system (PLIF + flexible pedicle screw system above the	CD HORIZON BalanC™ Medtronic	The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion.
PLIF	Solera™ Medtronic	The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF).

Primary Outcome Measures

Name	Time	Method
Changes in the subscores of physical pain and physical function in the ODI Questionaire	Baseline to 6 month

Secondary Outcome Measures

Name	Time	Method
MCS and individual dimensions and subscales of the SF-36™	60 Month