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
Scientific
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A trial to compare operative versus non-operative treatment of ruptures of the Achilles tendon |
| Study objectives | To 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) studied | Musculoskeletal Diseases: Achilles tendon |
| Intervention | Arm A: operative treatment Arm B: non-operative treatment |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Re-rupture rate and complications |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 patients per group |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Good Hope Hospital NHS Trust
Birmingham
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
