spondylolisthesis
Conditions
Interventions
biomaterials
bone healing
PET-CT
spinal fusion
Sponsors
Finceramica
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients who signed the ethics committee approved specific informed consent prior to surgery. 2. Male and non-pregnant female patients between 18-70 years of age. 3. Patients with a BMI
Exclusion criteria
Exclusion criteria: 1. Patients who are unwilling to cooperate with the study protocol and follow-up schedule. 2. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule. 3. Patients with bleeding history, hemophelia or systemic blood diseases 4. Female patients that are pregnant or planning a pregnancy during the course of the study 5. Obese patients where obesity is severe enough to affect subject*s ability to perform activities of daily living (body mass index, kg/m2 > 35) 6. Patients with active or suspected infection 7. Patients with malignancy * active malignancy within last 5 years 8. Patients known with a diagnosed systemic disease that would affect the subject*s welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget*s disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. 9. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient*s ability to limit weight bearing or places an extreme load on the implant during the healing period. 10. Patients with systemic or metabolic disorders leading to progressive bone deterioration 11. Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis. 12. Patients with a known sensitivity to device materials 13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse 14. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs. 15. Any prior surgical treatment at the surgical level in the lower lumbar spine 16. Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease. 17. Below 18 and over 70 years of age. 18. Known allergies to collagen of equine origin and to calcium phosphate salts 19. If per *operative fusion of 2 levels is necessary, this will not be a reason for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to investigate, using a prospective, longitudinal outcome study design to assess the use of REGENOSS in attaining spinal fusion in patients requiring single-level or 2 level Posterior Interbody Fusion of the lower lumbar spine. First objective of this clinical trial is to evaluate the success rates of REGENOSS in achieving bony fusion (defined as evidence of bridging trabecular bone present at 12 months assessed by Coronal CT scan by two independent reviewers. Fusion is deemed to exist if there is presence of bridging trabecular bone between the bones to be fused. CT scans will be graded in as described by Glassman et al. 2005 and Mobbs et al. 2014 1. Demonstrating no fusion on either side (grade 1) 2. Partial or limited unilateral fusion (grade 2) 3. Partial or limited bilateral fusion (grade 3) 4. Solid unilateral fusion (grade 4) 5. Solid bilateral fusion (grade 5). | — |
Secondary
| Measure | Time frame |
|---|---|
| Second objective of this clinical trial is assessment of the success rates of REGENOSS in achieving bony fusion as assessed by a 18F-Fluoride PET-CT scan by an independent reviewer. Two ratios will be calculated at each follow up: - bone metabolism activity of the control segment over the reference segment - bone metabolism activity of the endplate over the intervertebral disc space Both these ratios will be evaluated and compared between 6 weeks and 1year follow up. Third objective of this clinical trial is assessment and comparison of bone fusion, cage migration and instrument stability on the flexion extension X-rays at 6 weeks and 1 year. (>2 mm cage displacement or translation will be judged as pseudo-arthrosis). Fourth objective of this clinical trial is assessment of safety and absence of complications of application of REGENOSS in patients requiring single-level posterior interbody fusion in the lumbar spine During follow-up all adverse events and serious adverse events will be collected. Specifically cage migration will be assessed with flexion and extension X-ray analysis. The fifth objective of this clinical trial is to assess the clinical outcome improvement as assessed at 12 months in comparison to pre-operative scores: 1. Pain/Disability as measured by Oswestry Disability Index (ODI) 25-27 and VAS 28 2. Quality of Life as measured by SF-36 29 and EQ-5D 3L 30-31 At a later stage a comparison will be done of the 18F PET-CT images of this study group and a historic autologous bone study group. This will not be part of this underlying study. | — |
Countries
The Netherlands
Outcome results
None listed