Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/03/2016
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

Prof FD Burke

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Pulvertaft Hand Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 347141 ext 2258
frank.burke@virgin.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077111388

Study information

Scientific title

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

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Strength
2. Range of movement
3. Pain
4. Functional ability
5. Patient satisfaction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with osteo-arthritis at the base of the thumb who attend the Pulvertaft Hand Centre.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

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

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

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

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

04/03/2016: No publications found, verifying study status with principal investigator.