Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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

Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0) 2476 968618
matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093625

Study information

Scientific title

Acronym

Study hypothesis

Quantifying the effects of early mobilisation and loading for Achilles tendon 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

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Achilles tendon rupture

Intervention

1. Early loading in new orthosis
2. Traditional plaster cast treatment

A full quantitative assessment of the effects of early loading and mobilisation on Achilles tendon healing. The study is part of a three-centre randomised controlled trial comparing early loading in a new orthosis with traditional treatment in a plaster cast. Patients will be assessed with clinical, radiological, histological, anthropometric and questionnaire follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/02/2001

Overall trial end date

20/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

48 subjects (PROJ 01/02/2001).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

48

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

27/02/2001

Recruitment end date

20/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Cambridge Consortium - Addenbrooke's (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Medical Association (UK)

Alternative name(s)

BMA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

Publication citations

  1. Results

    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