No registrations found.
ID
Source
Brief title
Health condition
Acute Achilles tendon rupture
Sponsors and support
Divisie Heelkunde
Intervention
Outcome measures
Primary outcome
Complications of treatment.
Secondary outcome
Time off work, sporting activity post rupture and patient satisfaction.
Background summary
Background:
We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.<
Methods/Design:
At least 72 patients with acute Achilles tendon rupture will be randomized 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. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re-rupture, notably infection, disturbed wound healing and disturbed sensibility in the sural nerve area, adhesions and thrombosis. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture and patient satisfaction. Patient follow-up will be 12 month.
Study objective
The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.
Study design
N/A
Intervention
Patients with acute Achilles tendon rupture will be randomized 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.
R. Metz
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566024
metz_r@hotmail.com
R. Metz
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566024
metz_r@hotmail.com
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 18-65 years;
5. Informed consent.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL720 |
| NTR-old | NTR730 |
| Other | : N/A |
| ISRCTN | ISRCTN50141196 |