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

University of Cologne

Status: Unknown

Conditions: Spine Surgery

Treatments: Device: Solera™ Medtronic; Device: CD HORIZON BalanC™ Medtronic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02551302

Ortho-6-2015

Details and patient eligibility

About

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™)

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PLIF

Other group

Description:

The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF).

Treatment:

Device: Solera™ Medtronic

Hybrid system (PLIF + flexible pedicle screw system above the

Other group

Description:

The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion.

Treatment:

Device: CD HORIZON BalanC™ Medtronic