ISRCTN ISRCTN92180550
DOI https://doi.org/10.1186/ISRCTN92180550
Protocol serial number A0524
Sponsor Arthritis Research Campaign (ARC) (UK)
Funder Arthritis Research Campaign (UK)
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

Avon Orthopaedic Centre
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Phone +44 (0)117 959 5918
Email peallen@doctors.org.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleForefoot arthroplasty in rheumatoid arthritis
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRheumatoid arthritis
InterventionRandomised 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 typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/03/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaPatients with rheumatoid arthritis with forefoot involvement
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/1997
Date of final enrolment31/03/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Avon Orthopaedic Centre
Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

02/02/2017: No publications found in PubMed, verifying study status with principal investigator.