Arthrodesis of the lumbar spine at one level or at two contiguous levels between L2 and S1 to treat: 1. Degenerative pathologies (recurrent hernia, degenerative spondylolisthesis, symptomatic disc disease) 2. Spondylolisthesis by isthmic lysis 3. Spine deformity (scoliosis, instability) 4. Stenosis Musculoskeletal Diseases
Conditions
Interventions
The study design follows a prospective methodology. It is an observational PMCF study planned to be conducted in a standard of care setting in 2 sites in Geneva, to observe patients who underwent lumb
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Skeletally mature patients, aged =80 years 2. Treated by interbody fusion with JULIET-TI at 1 or 2 contiguous levels from L2 to S1 3. Symptomatic degenerative disc disease (SDDD), Recurrent herniated disc, Isthmic spondylolisthesis, or Degenerative spondylolisthesis Grade I 4. Non-smokers or recent quitters (for =3 months) 5. Treated non-surgically (for =6 months) 6. No previous surgery at the level to be treated, or previous surgery at the level to be treated without implantation of any material (i.e. operated for herniated disc or decompression)
Exclusion criteria
Exclusion criteria: 1. Previous surgery at the level to be treated with implantation of material (i.e. arthrodesis or arthroplasty) 2. Infection at the index level 3. Burst fracture and/or comminuted fracture of the vertebral body and/or vertebral plate 4. Osteoporosis, poor bone quality, or tumour 3. Current smokers 4. Spondylolisthesis Grade II or higher 6. Known metal sensitivity 7. Mental illness, hyperactivity 8. Neuromuscular and/or vascular disorder or illness 9. Pregnancy (current or planned next in the next 6 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interbody fusion status will be qualitatively assessed for all evaluable subjects, using SPECT-CT taken at 6 and 12 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety will be measured using adverse events (AEs), severe adverse events (SAEs), and complications recorded throughout the 12 month study period 2. Performance and clinical benefit: 2.1. Disability measured using the ODI functional assessment score at baseline (pre-operative), 3, 6, and 12 months 2.2. Pain measured using the VAS pain assessment score at baseline (pre-operative), 3, 6, and 12 months 2.3. Quality of life (QoL) measured using the Short form-12 (SF-12) self-assessment questionnaire score at baseline (pre-operative), 3, 6, and 12 months 2.4. Early bone metabolic signs of interbody fusion measured in the adjacent levels to implant by bone scan with SPECT-CT at 6 months 2.5. Primary stability measured using dynamic X-ray by ROM angles between flexion/extension at baseline and 3. Instrumentation support for the following tasks: to prepare the site of implantation, to select the adequate implant, to perform the implantation, to finalize the surgery; will be evaluated in terms of safety and performance using device and instrument assessment by the surgeon during and immediately after the surgery | — |
Countries
Germany, Switzerland
Outcome results
None listed