Condition category
Musculoskeletal Diseases
Date applied
09/03/2010
Date assigned
14/04/2010
Last edited
03/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Shabtai Friesem

ORCID ID

Contact details

Hardwick Road
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

NuNEC™ disc prosthesis versus Prestige® artificial cervical disc replacement: a prospective randomised controlled pilot trial

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Prospective randomised controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/05/2010

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/05/2010

Recruitment end date

01/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom

Sponsor information

Organisation

North Tees and Hartlepool NHS Foundation Trust (UK)

Sponsor details

University Hospital North Tees
Hardwick Road
Stockton On Tees
TS19 8PE
United Kingdom

Sponsor type

Government

Website

http://www.nth.nhs.uk/

Funders

Funder type

Government

Funder name

North Tees and Hartlepool NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/03/2016: Plain English summary added.