A trial to compare operative versus non-operative treatment of ruptures of the Achilles tendon
| ISRCTN | ISRCTN64598870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64598870 |
| Protocol serial number | N0523163138 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Good Hope Hospital NHS Trust (UK), Own account funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Re-rupture rate and complications |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| 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
- United Kingdom
- England
Study participating centre
Good Hope Hospital NHS Trust
Birmingham
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
