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

NCT02551302 | Unknown

• 1 other identifier: Ortho-6-2015
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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™)

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Changes in the subscores of physical pain and physical function in the ODI Questionaire

  Baseline to 6 month

Secondary Outcomes (1)

• MCS and individual dimensions and subscales of the SF-36™

  60 Month

Study Arms (2)

PLIF

OTHER

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

Device: Solera™ Medtronic

Hybrid system (PLIF + flexible pedicle screw system above the

OTHER

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

Interventions

Solera™ Medtronic DEVICE

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

PLIF

CD HORIZON BalanC™ Medtronic DEVICE

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

Hybrid system (PLIF + flexible pedicle screw system above the

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \>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)

Sponsors & Collaborators

• University of Cologne: lead
• Medtronic: collaborator

Study Officials

• Jan Siewe, Dr.med.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Siewe, Dr.med.

CONTACT

+49(0)221-478-87294; jan.siewe@uk-koeln.de

Margarete Wicharz

CONTACT

+49(0)221-478-87294; margarete.wicharz@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 16, 2015

Record last verified: 2015-09