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")"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spine Surgery

Interventions

Type	Name	Description
DEVICE	Solera™ Medtronic	The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
DEVICE	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

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-09-16
• Last updated: 2015-09-16