Degenerative Spondylolisthesis, Disc Degeneration of Pfirrmann Grade III or Greater, Isthmic Spondylolisthesis of Grade I or II
Conditions
Keywords
spondylolisthesis, disc degeneration, lumbar interbody fusion, randomized controlled trial, ceramic interbody spacer
Brief summary
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Interventions
DEVICEPosterior lumbar interbody fusion with a PEEK cage
PEEK cage suitable for oblique placement in the lumbar spine
DEVICEPosterior lumbar interbody fusion with a Valeo OL cage
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
Sponsors
Amedica Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients age 18-75 years * Chronic low back pain unresponsive to at least six months of conservative care * MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II
Exclusion criteria
* Osteoporosis * Patients with prior failed fusion at the same level * Degenerative scoliosis * Degenerative spondylolisthesis greater than Grade II * Pregnancy * Psychiatric or mental disease * Alcoholism (drinking more than 5 units per day) * Active infection or prior infection at the surgical site * Active cancer * Insufficient language skills to complete questionnaires * Participation in another study * More than two symptomatic levels that need fusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland Morris Disability Questionnaire (RMDQ) | 12 months post-op | The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion status | 3 mo., 6 mo., 12 mo., 24 months | Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed. |
| Oswestry Disability Index (ODI) | 12 months post-op | The improvement in the ODI over the pre-op ODI for each Group |
Countries
Netherlands
Outcome results
None listed