Contact information
Type
Scientific
Primary contact
Mr D R Sandeman
ORCID ID
Contact details
Department of Neurosciences
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
+44 (0)117 970 1212
richard.nelson@north-bristol.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234095390
Study information
Scientific title
Acronym
Study hypothesis
To compare an artificial cervical joint with anterior cervical fusion after a single level discetomy for spondylitic radiculopathy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cervical injuries
Intervention
Randomised trial.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Spinal stability.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/05/2000
Overall trial end date
01/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Patients presenting with cervical injuries.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
19/05/2000
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurosciences
Bristol
BS16 1LE
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
Hospital/treatment centre
Funder name
North Bristol 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
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12435973
Publication citations
-
Results
Wigfield CC, Gill SS, Nelson RJ, Metcalf NH, Robertson JT, The new Frenchay artificial cervical joint: results from a two-year pilot study., Spine, 2002, 27, 22, 2446-2452, doi: 10.1097/01.BRS.0000032365.21711.5E.