Forefoot arthroplasty in rheumatoid arthritis
| ISRCTN | ISRCTN92180550 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92180550 | 
| Secondary identifying numbers | A0524 | 
- Submission date
- 11/12/2002
- Registration date
- 11/12/2002
- Last edited
- 02/02/2017
- 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
                                            Miss PE Allen
Scientific
                                        Scientific
                                                Avon Orthopaedic Centre
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
                                                
| Phone | +44 (0)117 959 5918 | 
|---|---|
| peallen@doctors.org.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 | Forefoot arthroplasty in rheumatoid arthritis | 
| Study objectives | Not provided at time of registration | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Rheumatoid arthritis | 
| Intervention | Randomised to have one of two types of forefoot arthroplasty: 1. Modified Kates Kessel Kay type (excision of metatarsal heads through plantar incision) 2. Modified Stainsby procedure (excision base of proximal phalanges through dorsal incisions). All patients underwent arthrodesis of the 1st metatarsophalangeal joint. | 
| Intervention type | Other | 
| Primary outcome measure | Not provided at time of registration | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/04/1997 | 
| Completion date | 31/03/2000 | 
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 with rheumatoid arthritis with forefoot involvement | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 01/04/1997 | 
| Date of final enrolment | 31/03/2000 | 
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
                                            Avon Orthopaedic Centre
                                        
                                        
                                            
                                            Bristol
BS10 5NB
United Kingdom
                                    BS10 5NB
United Kingdom
Sponsor information
                                            Arthritis Research Campaign (ARC) (UK)
Charity
                                        Charity
                                                Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
                                                
| info@arc.org.uk | |
| Website | http://www.arc.org.uk | 
| https://ror.org/02jkpm469 | 
Funders
Funder type
Charity
                                                Arthritis Research Campaign (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
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.

