Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/04/2015
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 Ashvin Pimpalnerkar

ORCID ID

Contact details

Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0523163138

Study information

Scientific title

A trial to compare operative versus non-operative treatment of ruptures of the Achilles tendon

Acronym

Study hypothesis

To compare operative and non-operative treatment of ruptures of the Achilles tendon.

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

Musculoskeletal Diseases: Achilles tendon

Intervention

Arm A: operative treatment
Arm B: non-operative treatment

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Re-rupture rate and complications

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Complete Achilles tendon tear confirmed on ultrasound or MRI
2. Less than 10 days from date of injury
3. Aged 18 - 70 years old
4. Ability to follow rehab protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75 patients per group

Participant exclusion criteria

1. Significant ipsilateral injury
2. Open injury of the Achilles tendon
3. Neurological disease
4.Collagen disease
5. Pregnancy
6. Fluroquinolone associated rupture within 2 weeks of therapy
7. Unfit for surgery
8. Diabetes
9. Peripheral vascular disease
10. Avulsion of Achilles tendon

Recruitment start date

01/01/2005

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Good Hope Hospital NHS Trust
Birmingham
B75 7RR
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Good Hope Hospital NHS Trust (UK), Own account 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

Publication citations

Additional files

Editorial Notes