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

ISRCTN ISRCTN64598870
DOI https://doi.org/10.1186/ISRCTN64598870
Secondary identifying numbers N0523163138
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
20/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ashvin Pimpalnerkar
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA trial to compare operative versus non-operative treatment of ruptures of the Achilles tendon
Study objectivesTo compare operative and non-operative treatment of ruptures of the Achilles tendon.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Achilles tendon
InterventionArm A: operative treatment
Arm B: non-operative treatment
Intervention typeProcedure/Surgery
Primary outcome measureRe-rupture rate and complications
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants75 patients per group
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2005
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Good Hope Hospital NHS Trust
Birmingham
B75 7RR
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Good Hope Hospital NHS Trust (UK), Own account funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan