Contact information
Type
Scientific
Primary contact
Dr R Metz
ORCID ID
Contact details
Diakonessenhuis
Bosboomstraat 1
Utrecht
3582 KE
Netherlands
+31 (0)30 2566024
metz_r@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR730
Study information
Scientific title
Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing: design of a randomised controlled trial
Acronym
Study hypothesis
The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/02/2004
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Participant 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
Recruitment start date
01/02/2004
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Diakonessenhuis
Utrecht
3582 KE
Netherlands
Funders
Funder type
Research organisation
Funder name
Research foundation of Heelkunde University Medical Center Utrecht (UMCU) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/17986319
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18645042
Publication citations
-
Results
Metz R, Verleisdonk EJ, van der Heijden GJ, Clevers GJ, Hammacher ER, Verhofstad MH, van der Werken C, Acute Achilles tendon rupture: minimally invasive surgery versus nonoperative treatment with immediate full weightbearing--a randomized controlled trial., Am J Sports Med, 2008, 36, 9, 1688-1694, doi: 10.1177/0363546508319312.