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

Spine Surgery Clinical Trial

— BalanC  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02551302
• Other study ID #: Ortho-6-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 15, 2015
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: University of Cologne
• Contact: Jan Siewe, Dr.med.
• Phone: +49(0)221-478-87294
• Email: jan.siewe[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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™)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Device:
• Solera™ Medtronic
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the subscores of physical pain and physical function in the ODI Questionaire		Baseline to 6 month	No
Secondary	MCS and individual dimensions and subscales of the SF-36™		60 Month	No