Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis Musculoskeletal Diseases Spondylolisthesis
Conditions
Interventions
Lumbar surgery: Over a period of two years participants will be followed on a regular basis (3, 6, 12 and 24 months) to assess clinical outcomes and radiological parameters. Patients will be asked to
Sponsors
Zimmer Spine (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or over 2. Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 3. ODI over or equal to 40/100 4. Back pain over or equal to 4/10 5. Mono segmental lumbosacral disease fulfilling the prior conditions: only one level between L2 and S1 6. Skeletally mature patients 7. Six months failed conservative treatment 8. Gave written consent to take part in the study by signing patient informed consent form 9. Physically and mentally able to comply with the protocol, including ability to read and complete required forms and adhere to the follow-up requirements of the protocol
Exclusion criteria
Exclusion criteria: 1. Prior surgical procedure at the index level using the desired operative approach 2. Severe degenerative lesions at more than one level of the lumbosacral spine 3. Morbid obesity (BMI = 40) 4. Active local infection in or near the operative region 5. Active systemic infection and/or disease 6. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation 7. Known or suspected sensitivity to the implant materials 8. Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism) 9. Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs 10. Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury) 11. Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care 12. Pregnant 13. Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities 14. Current vertebral metastatic tumors 15. Symptomatic cardiac disease 16. Severe congenital or acquired vertebral deformities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in patient's Oswestry Disability Index (ODI) score after TM Ardis cage insertion. A 15-point ODI improvement is expected to claim success of the criterion. Measure will be assessed preoperatively at 3, 6, 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of implant-related complications defined as subsidence, breakage, migration and retrieval. Except radiological tests, the outcomes will be measured with questionnaires in native language preoperatively at 3, 6, 12 and 24 months. Radiological parameters calculation will be assessed by an external company. | — |
Countries
Belgium, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed