Contact information
Type
Scientific
Primary contact
Mr Adrian TH Casey
ORCID ID
Contact details
Neuro-Urology Department
Spinal Injuries Unit
Royal National Orthopaedic Hospital NHS Trust
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
+44 (0)20 8908 5720
athcasey@doctors.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0209121271
Study information
Scientific title
Cervical disc replacement versus inter-body cage for the treatment of spondylotic disease: a randomised, prospective double-blind clinical trial
Acronym
Study hypothesis
Is the Bryan disc a better alternative than traditional discectomy and fusion for the treatment of cervical spondylotic disease?
Ethics approval
Not provided at time of registration
Study design
Randomised prospective double-blind clinical 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 to request a patient information sheet
Condition
Musculoskeletal Diseases: Spondylotic disease
Intervention
Surgery, followed by clinical outcome measures and quality of life score.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
SF-36, Neck disease Index, Myelopathy Disability Index, Visual Analogue Scale
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having cervical discectomy and insertion of cervical disc replacement
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2003
Recruitment end date
01/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Orthopaedic Hospital NHS Trust
Stanmore
HA7 4LP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal National Orthopaedic Hospital NHS 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