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 |
| Protocol serial number | N0209121271 |
| Sponsor | Department of Health (UK) |
| Funder | Royal National Orthopaedic Hospital NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised prospective double-blind clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
SF-36, Neck disease Index, Myelopathy Disability Index, Visual Analogue Scale |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Royal National Orthopaedic Hospital NHS Trust
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/06/2017: No publications found, verifying study status with principal investigator.
