Prospective randomised controlled study comparing an artificial cervical joint with anterior cervical fusion after a single level discetomy for spondylitic radiculopathy
| ISRCTN | ISRCTN43742546 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43742546 | 
| Secondary identifying numbers | N0234095390 | 
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Mr D R Sandeman
Scientific
                                        Scientific
                                                Department of Neurosciences
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
                                                
| Phone | +44 (0)117 970 1212 | 
|---|---|
| richard.nelson@north-bristol.swest.nhs.uk | 
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Treatment | 
| Scientific title | |
| Study objectives | To compare an artificial cervical joint with anterior cervical fusion after a single level discetomy for spondylitic radiculopathy. | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Cervical injuries | 
| Intervention | Randomised trial. | 
| Intervention type | Procedure/Surgery | 
| Primary outcome measure | Spinal stability. | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 19/05/2000 | 
| Completion date | 01/09/2003 | 
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 presenting with cervical injuries. | 
| Key exclusion criteria | Does not match inclusion criteria | 
| Date of first enrolment | 19/05/2000 | 
| Date of final enrolment | 01/09/2003 | 
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
                                            Department of Neurosciences
                                        
                                        
                                            
                                            Bristol
BS16 1LE
United Kingdom
                                    BS16 1LE
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
Hospital/treatment centre
                                                North Bristol 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 | 
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? | 
|---|---|---|---|---|---|
| Results article | results | 15/11/2002 | Yes | No | 

