Cervical disc replacement versus inter-body cage for the treatment of spondylotic disease: a randomised, prospective double-blind clinical trial
| ISRCTN | ISRCTN35985647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35985647 |
| Secondary identifying numbers | N0209121271 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 08/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Adrian TH Casey
Scientific
Scientific
Neuro-Urology Department
Spinal Injuries Unit
Royal National Orthopaedic Hospital NHS Trust
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
| Phone | +44 (0)20 8908 5720 |
|---|---|
| athcasey@doctors.org |
Study information
| Study design | Randomised prospective double-blind clinical 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 | Cervical disc replacement versus inter-body cage for the treatment of spondylotic disease: a randomised, prospective double-blind clinical trial |
| Study objectives | Is the Bryan disc a better alternative than traditional discectomy and fusion for the treatment of cervical spondylotic disease? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Spondylotic disease |
| Intervention | Surgery, followed by clinical outcome measures and quality of life score. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | SF-36, Neck disease Index, Myelopathy Disability Index, Visual Analogue Scale |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2003 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients having cervical discectomy and insertion of cervical disc replacement |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal National Orthopaedic Hospital NHS Trust
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Royal National Orthopaedic Hospital NHS Trust (UK)
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
08/06/2017: No publications found, verifying study status with principal investigator.
