Surgical replacement of the cervical intervertebral discs (C3 to C7) for patients requiring surgical intervention for total cervical disc replacement for the treatment of discogenic pain (neck/shoulder/arm)
Conditions
Interventions
None listed
Sponsors
Clinical and Regulatory Affairs
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Skeletally mature patients (aged 18 years 65 years), 2. Not pregnant or lactating at the time of surgery, 3. Has cervical disc syndrome as defined as radiculopathy with or without accompanying cervical pain with symptomatic nerve root compression documented by patient history, clinical examination and confirmed by MRI or CT/myelogram, showing cervical disc herniation or nerve root entrapment 4. One level cervical disc syndrome where the implantation may or may not be adjacent to a pre-existent fusion 5. Proposed surgical level at C3- C7 inclusive, 6. Unresponsive to conservative, i.e. non-surgical management, such as pharmaceutical, physiotherapy or surgical micro-discectomy/decompression for six weeks or presence of progressive symptoms or signs of cord compression, 7. No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level other than outlined in inclusion criterion 4, 8. Arm Pain score of >= 20 based on Visual Analogue Scale, may be with Preop Neck Disability index score >= 30 9. Capable of and willing to comply to the study protocol in the opinion of the Investigator, including a is willingness to return to the hospital for all the required post-operative follow-up visits, 10. Capable of and willing to provide voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment. 11. Mild signs of myelopathy without change to the spinal cord as seen on T2-MRI
Exclusion criteria
Exclusion criteria: a. Arm pain confirmed as non discogenic in origin b. Undergone previous cervical spinal surgery at the index level that could affect the trial outcome (e.g., disc replacement or previous fusion), c. Radiographic evidence of facet degeneration or severe facet disease, d. Active infection or metastatic, autoimmune or terminal disease e. Osteoporosis, osteopenia or other metabolic bone disease or endocrine disorder known to affect osteogenesis, f. Significant spinal deformity such as osteophytes, sclerotic facets, g. Pre-existing neurological abnormalities or other deficits, e.g. Parkinson*s disease, diabetic neuropathy, MS, cerebro-vascular accident, peripheral neuropathy, h. Significant loss of disc height >50% i. Clinically compromised vertebral bodies at the affected level due to current or past trauma j. Subject is skeletally immature as determined by the investigator k. Instability of the cervical spine as defined radiographically (Panjabi & White [1990]), if suspected: a. Flexion extension saggital plane translation >3.5mm or 20% and saggital plane rotation > 20°, OR b. Resting X-rays: saggital plane displacement > 3.5mm or 20% and relative saggital plane angulation >11º l. Myelopathy with change to the spinal cord as seen on T2-MRI m. Morbid Obesity BMI>40 n. Unwillingness or inability to give consent or adhere to the follow-up programme o. Drug or alcohol dependency p. Currently involved in injury litigation q. Known allergy to any of the implant materials r. Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days s. Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of the proportion of subjects who show clinical success, where success is described by the following components: 1. An improvement of 15 points on the arm VAS score at 3 months post-operatively 2. An improvement of 15 points on the NDI scale at 3 months post-operatively, compared to baseline 3. No significant adverse events A participant is defined as a success if: • 1 and 3 are true, or • 1 and 2 and 3 are true. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect on the subjects* visual analogue score (VAS) pain score at 6 weeks, 3, 6, 12 and 24 months post-treatment as compared with pre-treatment (baseline) scores. 2. The number of participants who show an improvement of 15 points on the NDI scale at 6 weeks, and 6, 12 and 24 months post-surgery, compared to baseline, i.e. pre-operative, scores, expressed as a proportion. 3. The mean and 95% confidence interval NDI scores at 6 weeks, 3, 6, 12 and 24 months post-treatment as compared with pre-treatment (baseline) scores. 4. The effect on physical functioning and bodily pain scores from the SF-36 and EQ-5D patient questionnaire at 6 weeks, 3, 6, 12 and 24 months post-treatment as compared with pre-treatment (baseline) scores. 5. The effect on the participants* disc height at the operative disc level as determined by lateral radiographs at 3, 6, 12 and 24 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 and 24 months post-treatment as compared with immediate post-treatment (t = 0) levels. 7. The effect on the subjects* motion at the operative disc level as determined by flexion/extension radiographs at 6, 12 and 24 months post-treatment as compared with pre-treatment (baseline) levels. 8. Proportion of surgical revision at the level of intervention within 3, 6, 12 and 24 months. 9. Proportion of patient expressing a preference for surgery at 12 and 24 months. 10. Degree of heterotopic ossification forming post operatively from 3 to 24 months. 11. Degree of adjacent segment disease. | — |
Countries
Netherlands
Outcome results
None listed