Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/07/2008
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 Matthew Costa

ORCID ID

Contact details

Associate Professor Trauma and Orthopaedics Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 02476 968618
matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547061010

Study information

Scientific title

Acronym

Study hypothesis

The study aims to assess the potential of an 'off-the-shelf' orthosis in speeding the recovery of patients with tendo-Archilles rupture.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Tendo-Achilles rupture

Intervention

Randomised study using a modified 'off-the-shelf' orthosis versus usual postoperative treatment with a plaster cast. Speeding the recovery of patients by earlier weight bearing.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Speeding the recovery of patients.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1999

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/1999

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Associate Professor Trauma and Orthopaedics Warwick Medical School
Coventry
CV2 2DX
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

Government

Funder name

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK) + British Medical Association funding

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16365124 - this is the operatively-treated patients trial.

Publication citations

  1. Costa ML, MacMillan K, Halliday D, Chester R, Shepstone L, Robinson AH, Donell ST, Randomised controlled trials of immediate weight-bearing mobilisation for rupture of the tendo Achillis., J Bone Joint Surg Br, 2006, 88, 1, 69-77, doi: 10.1302/0301-620X.88B1.16549.

Additional files

Editorial Notes