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
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