Cervical disc degeneration Musculoskeletal Diseases Cervical disc disorders
Conditions
Interventions
Anterior cervical decompression and disc replacement using either NuNEC™ or Prestige® cervical disc replacement.
Standard and accepted clinical and radiological parameters will be evaluated and compa
Sponsors
North Tees and Hartlepool NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Single, double or multi-level cervical degenerative disc disease in any age group and sex 2. Failed conservative treatment which includes reduction of activities, physical therapy and anti-inflammatory medications 3. Acute severe grade motor or sensory deficit 4. Cervical radiculopathy - neck arthritis (wear and tear in the neck) causing arm pain because of pressure on nerves 5. Cervical myelopathy - neck arthritis causing arm pain and coordination problem because of pressure on spine or the nerves coming out of spine 6. Combination of cervical radiculopathy and myelopathy symptoms 7. Hard and soft disc pathology
Exclusion criteria
Exclusion criteria: 1. Participants unable to consent for the trial 2. Patients not willing to take part in the study 3. Patients participating in other clinical trials 4. Patients with previous surgery involving neck excluding injections 5. Severe facet joint arthritis involving cervical spine 6. History of discitis at the same level of surgery 7. Cervical instability: sagittal-plane translation greater than 3.5 mm, or sagittal plane angulation grater than 20 degrees at a single level 8. Lack of movement at the disc level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard and accepted clinical and radiological parameters will be evaluated and compared pre-operatively and post-operatively at 6 weeks, 3 months, 6 months, 1, 2, 3, 4 and 5 years following surgery. Clinical: 1. Visual Analogue score for neck pain (VAS-NP), from 0 = no pain, to 10 = extremely painful. This is a valid assessment tool to assess the effectiveness providing relief of neck pain which has been used in similar trials. 2. Visual Analogue score for arm pain (VAS-AP), from 0 = no pain, to 10 = extremely painful. This is a valid assessment tool to assess the effectiveness providing relief of neck pain which has been used in similar trials. 3. Neck Disability Index (NDI). Valid assessment questionnaire used to assess the effectiveness treatment in reducing neck pain, headaches and their influence on work, reading, lifting, sleeping and recreation, which has been used in similar trials in the past. An improvement in scores by 15 points in NDI is considered as good outcome following surgery. 4. 36-item short form health survey (SF-36). This is a validated assessment questionnaire used to assess the effectiveness of the treatment in improving the physical health, mental health and general overall wellbeing. Radiological: 5. AP view (X-ray taken from front of neck) - to assess the prosthesis alignment 6. Lateral view (X-ray examination done from the side of the neck) - disc space measurements, kyphotic angle 7. Flexion/extension views (in addition) - radiological examination performed with the patient bending and extending the neck. These x-rays are performed 6 weeks onwards to ascertain the degree of movement at each level. 8. Adjacent level disc degeneration - magnetic resonance imaging (MRI)/computed tomography (CT) evaluation are performed to if adjacent/same level pathology is suspected at any time during follow-up. These are the standard accepted imaging techniques used in other similar studies in the past. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluated in the clinic, ranging from 6 weeks until the end of the trial: 1. Return to work 2. Clinical range of movement 3. Lack of movement (x-ray evidence of less than 4 degrees of dynamic motion) 4. Radiolucency more than 50% implant surface 5. Implant failure 6. Migration 7. Subjacent level disc degeneration 8. Adjacent-segment re-operation 9. Other common complications related to operation 10. Implant failure (breakage) or subsidence or radiological loosening causing neurological deficit at same level necessitating further surgery at same level is considered as failure of primary treatment These are standardised secondary outcome measures as suggested by other similar studies. | — |
Countries
United Kingdom
Outcome results
None listed