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ISRCTN
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ISRCTN50141196
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ClinicalTrials.gov identifier
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Public title
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Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing: design of a randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR730
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Study hypothesis
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The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Acute Achilles tendon rupture
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2004
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Anticipated end date
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01/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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72
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Interventions
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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.
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Primary outcome measure(s)
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Reduction in complications other than re-rupture.
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Secondary outcome measure(s)
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1. Re-rupturing
2. Time off work
3. Sporting activity post rupture
4. Functional outcome by Leppilahti score
5. Patient satisfaction
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Sources of funding
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Research foundation of Heelkunde University Medical Center Utrecht (UMCU) (The Netherlands)
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Trial website
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Publications
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Design in: http://www.ncbi.nlm.nih.gov/pubmed17986319
Results in: http://www.ncbi.nlm.nih.gov/pubmed/18645042
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Contact name
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Dr
R
Metz
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Address
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Diakonessenhuis
Bosboomstraat 1
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City/town
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Utrecht
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Zip/Postcode
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3582 KE
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Country
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Netherlands
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Tel
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+31 (0)30 2566024
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Email
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metz_r@hotmail.com
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Sponsor
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University Medical Center Utrecht (UMCU) (The Netherlands)
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Address
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Department of Surgery
Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584 CX
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Country
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Netherlands
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Date applied
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27/09/2006
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Last edited
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25/07/2008
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Date ISRCTN assigned
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27/09/2006
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