NuNEC™ disc prosthesis versus Prestige® artificial cervical disc replacement: a pilot study
| ISRCTN | ISRCTN63878911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63878911 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/03/2010
- Registration date
- 14/04/2010
- Last edited
- 06/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
As you age the discs between your neck bones lose their integrity, strength and movement, putting pressure on your nerves that can lead to neck and arm pain. Replacing these diseased discs with artificial discs can improve the pain and other problems associated with it. We are using two types of artificial disc replacement prosthesis in our hospital at present. The Prestige® disc prosthesis is made of metal, which can cause problems if MRI scans have to be performed. This prosthesis has been in use for many years and has had good results so far. The NuNEC™ disc prosthesis is a newer prosthesis and is made of a material called polyetherether-ketone (PEEK; a non-metal material). This is compatible with MRI and provides good images. The results so far are encouraging, and long-term results are awaited. This study is being conducted to compare the outcomes following these two types of disc replacement.
Who can participate?
Patients of any age with cervical degenerative disc disease
What does the study involve?
Participants are randomly allocated to undergo surgical disc replacement using either the NuNEC™ or Prestige® prosthesis. Neck and arm pain are assessed and x-rays are performed before surgery and at 6 weeks, 3 months, 6 months, 1, 2, 3, 4 and 5 years after surgery.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital of North Tees (UK)
When is the study starting and how long is it expected to run for?
May 2010 to May 2016
Who is funding the study?
North Tees and Hartlepool NHS Foundation Trust (UK)
Who is the main contact?
Mr Shabtai Friesem
Contact information
Scientific
Hardwick Road
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom
Study information
| Study design | Prospective randomised controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | NuNEC™ disc prosthesis versus Prestige® artificial cervical disc replacement: a prospective randomised controlled pilot trial |
| Study objectives | Is the clinical and radiological outcome following anterior cervical decompression disc replacement using NuNEC™ (PEEK on PEEK) prosthesis better than or same as Prestige® disc (metal on metal) replacement at short to long term follow-up (i.e., 6 months, 1, 2, 3, 4 and 5 years)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervical disc degeneration |
| Intervention | 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 compared pre-operatively and post-operatively at 6 weeks, 3 months, 6 months, 1, 2, 3, 4 and 5 years following surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/05/2010 |
| Completion date | 01/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TS19 8PE
United Kingdom
Sponsor information
Hospital/treatment centre
University Hospital North Tees
Hardwick Road
Stockton On Tees
TS19 8PE
England
United Kingdom
| Website | http://www.nth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04zzrht05 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/06/2018: No publications found, verifying study status with principal investigator.
03/03/2016: Plain English summary added.
