Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing
ISRCTN | ISRCTN50141196 |
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DOI | https://doi.org/10.1186/ISRCTN50141196 |
Secondary identifying numbers | NTR730 |
- 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 |
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metz_r@hotmail.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | Reduction in complications other than re-rupture. |
Secondary outcome measures | 1. Re-rupturing 2. Time off work 3. Sporting activity post rupture 4. Functional outcome by Leppilahti score 5. Patient satisfaction |
Overall study start date | 01/02/2004 |
Completion date | 01/10/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
University/education
University/education
Department of Surgery
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
https://ror.org/0575yy874 |
Funders
Funder type
Research organisation
Research foundation of Heelkunde University Medical Center Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 06/11/2007 | Yes | No | |
Results article | results | 01/09/2008 | Yes | No |
Editorial Notes
13/09/2017: internal review.