A randomised controlled single blind trial comparing STTJ (scapho-trapezio-trapezoid joint)fusion and pyrocarbon interposition arthroplasty for osteoarthritis of the scapho-trapezio-trapezoid joint

ISRCTN ISRCTN12076542
DOI https://doi.org/10.1186/ISRCTN12076542
Secondary identifying numbers N0106175335
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
30/08/2012
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

Not provided at time of registration

Contact information

Mr Peter Tomlinson
Scientific

Gloucestershire Hospitals NHS Foundation Trust
Cheltenham General Hospital
Sandford Road
Blackpool
GL53 7AN
United Kingdom

Phone +44 (0) 8454 223585

Study information

Study designRandomised controlled single blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study hypothesisIs the pyrocarbon interposition arthroplasty (pyrocarbon button) better than STTJ fusion for arthritis of the scapho-trapezio-trapezoid?
Ethics approval(s)Not provided at time of registration
ConditionMusculoskeletal Diseases: Osteoarthritis (OA)
InterventionGroup 1 (n=40) = STTJ fusion - standard procedure
Group 2 (n=40) = pyrocarbon interposition arthroplasty
Intervention typeOther
Primary outcome measureAssessment of pain
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2005
Overall study end date01/11/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants80
Participant inclusion criteriaPatients who have STTJ osteoarthritis who have exhausted conservative methods of treatment.
Participant exclusion criteriaPatents with extensive osteaoarthritis that includes the carpometacarpal joint who are not suitable for the procedure.
Recruitment start date01/11/2005
Recruitment end date01/11/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Gloucestershire Hospitals NHS Foundation Trust
Blackpool
GL53 7AN
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Gloucestershire R&D Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan