Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing
| ISRCTN | ISRCTN50141196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50141196 |
| Protocol serial number | NTR730 |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funder | Research foundation of Heelkunde University Medical Center Utrecht (UMCU) (The Netherlands) |
- Submission date
- 27/09/2006
- Registration date
- 27/09/2006
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Metz
Scientific
Scientific
Diakonessenhuis
Bosboomstraat 1
Utrecht
3582 KE
Netherlands
| Phone | +31 (0)30 2566024 |
|---|---|
| metz_r@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing: design of a randomised controlled trial |
| Study objectives | The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute Achilles tendon rupture |
| Intervention | Patients with acute Achilles tendon rupture will be randomised to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Patient follow-up will be 12 month. |
| Intervention type | Other |
| Primary outcome measure(s) |
Reduction in complications other than re-rupture. |
| Key secondary outcome measure(s) |
1. Re-rupturing |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key inclusion criteria | 1. Primary spontaneous Achilles tendon rupture 2. Treatment starts within 72 hours after rupture 3. Diagnoses by physical examination: palpable gap and calf muscle squeeze test positive for tendon rupture 4. Age 18 to 65 years 5. Informed consent |
| Key exclusion criteria | 1. Re-rupture/bilateral rupture/open rupture 2. Combination with fracture of foot or ankle 3. Former application (injection) of local corticosteroids in tendon area 4. Contra-indications for surgery 5. Physical or mental handicaps that do not allow functional treatment or otherwise interfere with the ability to follow-up on the study protocol |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diakonessenhuis
Utrecht
3582 KE
Netherlands
3582 KE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2008 | Yes | No | |
| Protocol article | protocol | 06/11/2007 | Yes | No |
Editorial Notes
13/09/2017: internal review.
