Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Tomlinson

ORCID ID

Contact details

Gloucestershire Hospitals NHS Foundation Trust
Cheltenham General Hospital
Sandford Road
Blackpool
GL53 7AN
United Kingdom
+44 (0) 8454 223585

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0106175335

Study information

Scientific title

Acronym

Study hypothesis

Is the pyrocarbon interposition arthroplasty (pyrocarbon button) better than STTJ fusion for arthritis of the scapho-trapezio-trapezoid?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled single blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoarthritis (OA)

Intervention

Group 1 (n=40) = STTJ fusion - standard procedure
Group 2 (n=40) = pyrocarbon interposition arthroplasty

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Assessment of pain

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2005

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have STTJ osteoarthritis who have exhausted conservative methods of treatment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Patents with extensive osteaoarthritis that includes the carpometacarpal joint who are not suitable for the procedure.

Recruitment start date

01/11/2005

Recruitment end date

01/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Blackpool
GL53 7AN
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Gloucestershire R&D Consortium (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

Publication citations

Additional files

Editorial Notes