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

September 15, 2015 updated by: Dr. Jan Siewe, University of Cologne
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™)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PLIF
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF).
Device: Solera™ Medtronic
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
Other: Hybrid system (PLIF + flexible pedicle screw system above the
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the subscores of physical pain and physical function in the ODI Questionaire
Time Frame: Baseline to 6 month
Baseline to 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
MCS and individual dimensions and subscales of the SF-36™
Time Frame: 60 Month
60 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Medtronic

Investigators

  • Principal Investigator: Jan Siewe, Dr.med., University Hospital Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Ortho-6-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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