"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid... | NCT02551302

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Sep 15, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2015

Last Update Posted Date

Sep 16, 2015Estimated

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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™)

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Solera™ Medtronic	Device	The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic	PLIF

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
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