Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123138157
Study information
Scientific title
Acronym
Study hypothesis
To see if the longer recovery time for the more complex operation is justified and produces a better thumb than the simpler operation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Trapeziometacarpal osteoarthritis
Intervention
Patients 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2001
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with osteoarthritis of the trapeziometacarpal join.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
183
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2001
Recruitment end date
01/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals of Leicester NHS Trust (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
One-year results in http://www.ncbi.nlm.nih.gov/pubmed/15576217
Publication citations
-
Davis TR, Brady O, Dias JJ, Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint: a study of the benefit of ligament reconstruction or tendon interposition., J Hand Surg Am, 2004, 29, 6, 1069-1077, doi: 10.1016/j.jhsa.2004.06.017.