A prospective, randomised, clinical trial comparing trapezial denervation with trapeziectomy for the surgical treatment of arthritis at the base of the thumb

ISRCTN	ISRCTN66686094
DOI	https://doi.org/10.1186/ISRCTN66686094
Secondary identifying numbers	N0077111388

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 23/04/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof FD Burke
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Pulvertaft Hand Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone	+44 (0)1332 347141 ext 2258
Email	frank.burke@virgin.net

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A prospective, randomised, clinical trial comparing trapezial denervation with trapeziectomy for the surgical treatment of arthritis at the base of the thumb
Study hypothesis	Trapezial denervation offers the most effective option available with a shorter operating time and rapid rehabilitation at less cost to both patient and hospital.
Ethics approval(s)	Not provided at time of registration
Condition	Treatment of arthritis at the base of the thumb
Intervention	A range of objective and subjective assessments carried out by the Occupational Therapists at three intervals: 1. Prior to surgery 2. 6 months after surgery 3. 12 months after surgery 4. 5 years after surgery Measure of Health Status, using EQ5D.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Strength 2. Range of movement 3. Pain 4. Functional ability 5. Patient satisfaction
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2002
Overall study end date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Total final enrolment	55
Participant inclusion criteria	Patients with osteo-arthritis at the base of the thumb who attend the Pulvertaft Hand Centre.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/07/2002
Recruitment end date	31/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE1 2QY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Charity

Southern Derbyshire Acute Hospitals NHS Trust (UK) - NHS R&D Support Funding and Charitable Funds

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		13/02/2019	23/04/2025	Yes	No

Editorial Notes

23/04/2025: Publication reference and total final enrolment added.
30/04/2018: No publications found, study status unverified.
04/03/2016: No publications found, verifying study status with principal investigator.