chronic low back pain Surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar disc replacement for the treatment of debilitating
Conditions
Interventions
None listed
Sponsors
Ranier Technology Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is male or non pregnant, non-lactating female Subject is aged between 25-65 years (inclusive) Subject has a BMI 30 points Subject has chronic low back pain, and is in the opinion of the investigator a suitable candidate for anterior lumbar surgery Subject has completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief Subject has degenerative disc changes at a single level between L3 - L4, or L4 - L5, or L5 - S1 as confirmed by positive discography and visualised by X-Ray, CT or MRI scan and/or with one or more of the following: i decrease in disc height
Exclusion criteria
Exclusion criteria: Subject has back or leg pain of unknown aetiology Subject has radicular or sciatic pain which is more severe than low back pain Subject has undergone previous lumbar spinal surgery which could affect the trial outcome (e.g., disc replacement) Subject has obvious signs of psychological or worker compensation or litigation claim elements to their condition, or are actively engaged in such activities Subject is unwilling or unable to give consent or adhere to the follow-up programme Subject has active infection or metastatic disease Subject has non-degenerative spondylolisthesis Subject has degenerative spondylolisthesis > grade 1 Subject has a known allergy to any of the implant materials Subject has osteoporosis (if suspected to be confirmed by bone density being 2.5SD below normal as assessed using DEXA analysis in post-menopausal females if suggested by X-ray or other risk factors) Subject has osteopenia Subject has bony lumbar stenosis Subject has pars defect Isolated radicular compression syndromes, especially due to disc herniation Clinically compromised vertebral bodies at the affected level due to current or past trauma Subject is skeletally immature as determined by the investigator Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids. Subject has uncorrected iliac, aorto-iliac, or aortic aneurysm disease. Spinal instability (> 3mm translation or > 5° angulation) confirmed by functional radiological assessment. Subject has degenerative disc changes at the L6 - S1 level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of participants who show an improvement of 15 points on the ODI (Oswestry Disability Index) scale at 3 months post-surgery, compared to baseline, i.e. pre-operative, scores, expressed as a ratio. This endpoint is widely used as the key performance indicator of a therapeutic effectiveness, and has been used in the largest clinical trials38,39 of spinal devices | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The number of participants who show an improvement of 15 points on the ODI scale at 6 weeks, and 6, 12, 24, 36, 48 and 60 months post-surgery, compared to baseline, i.e. pre-operative, scores, expressed as a proportion. 2.The mean and 95% confidence interval ODI scores at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-treatment as compared with pre-treatment (baseline) scores. 3.The effect on physical functioning and bodily pain scores from the SF-36 patient questionnaire at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-treatment as compared with pre-treatment (baseline) scores. 4.The effect on the subjects* VAS leg and back pain score at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-treatment as compared with pre-treatment (baseline) scores. 5.The effect on the subjects* disc height at the operative disc level as determined by lateral radiographs at 3, 6, 12, 24, 36, 48 and 60 months post-treatment as compared with pre-treatment (baseline) levels. 6.The effect on the subjects* disc height at the operative disc level as determined by lateral radiographs at 3, 6, 12, 24, 36, 48 and 60 months post-treatment as compared with immediate post-treatment (baseline) levels. 7.The effect on the subjects* motion at the operative disc level as determined by flexion/extension radiographs at 6, 12, 24 and 60 months post-treatment as compared with pre-treatment (baseline) levels. 8.Proportion of surgical revision at the level of intervention within 3, 6, 12, 24, 36, 48 and 60 months. 9.Evaluation of the number, frequency and severity of any adverse device events. | — |
Countries
Netherlands
Outcome results
None listed