Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint. Is there any benefit to ligament reconstruction?

ISRCTN ISRCTN22417311
DOI https://doi.org/10.1186/ISRCTN22417311
Secondary identifying numbers N0123138157
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
17/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Joseph Dias
Scientific

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo see if the longer recovery time for the more complex operation is justified and produces a better thumb than the simpler operation.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedTrapeziometacarpal osteoarthritis
InterventionPatients randomised to:
1. Simple trapeziectomy
2. Trapeziectomy with palmaris longus interposition
3. Trapeziectomy with ligament reconstruction and tendon interposition using 50% of the flexor carpi radialis tendon

All patients wore a thumb splint for 6 weeks. Patients were followed up for 1 year.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2001
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants183
Key inclusion criteriaPatients with osteoarthritis of the trapeziometacarpal join.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2001
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

University Hospitals of Leicester NHS Trust (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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article One-year results 01/11/2004 Yes No