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Acute Achilles tendon rupture: Minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial.


- candidate number2195
- NTR NumberNTR730
- ISRCTNISRCTN50141196
- Date ISRCTN created27-sep-2006
- date ISRCTN requested27-sep-2006
- Date Registered NTR6-aug-2006
- Secondary IDsN/A 
- Public TitleAcute Achilles tendon rupture: Minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial.
- Scientific TitleAcute Achilles tendon rupture: Minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial.
- ACRONYMN/A
- hypothesisThe study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.
- Healt Condition(s) or Problem(s) studiedAcute achilles rupture
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2004
- planned closingdate1-okt-2006
- Target number of participants80
- InterventionsPatients 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.
- Primary outcomeComplications of treatment.
- Secondary outcomeTime off work, sporting activity post rupture and patient satisfaction.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES R. Metz
- CONTACT for SCIENTIFIC QUERIESDr. E.J.M.M. Verleisdonk
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Researchfundation Heelkunde University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD6-aug-2006 - 9-sep-2009


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