Spine Surgery
Conditions
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
Interventions
DEVICESolera™ Medtronic
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
DEVICECD 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
Sponsors
Medtronic
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the subscores of physical pain and physical function in the ODI Questionaire | Baseline to 6 month |
Secondary
| Measure | Time frame |
|---|---|
| MCS and individual dimensions and subscales of the SF-36™ | 60 Month |
Contacts
Primary ContactJan Siewe, Dr.med.
Backup ContactMargarete Wicharz
Outcome results
None listed