Acute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing

ISRCTN ISRCTN50141196
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

Diakonessenhuis
Bosboomstraat 1
Utrecht
3582 KE
Netherlands

Phone +31 (0)30 2566024
Email metz_r@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAcute achilles tendon rupture - minimally invasive surgery versus non-operative treatment, with immediate full weight bearing: design of a randomised controlled trial
Study objectivesThe 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) studiedAcute Achilles tendon rupture
InterventionPatients 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 typeOther
Primary outcome measureReduction in complications other than re-rupture.
Secondary outcome measures1. Re-rupturing
2. Time off work
3. Sporting activity post rupture
4. Functional outcome by Leppilahti score
5. Patient satisfaction
Overall study start date01/02/2004
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants72
Key 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 to 65 years
5. Informed consent
Key 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
Date of first enrolment01/02/2004
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Diakonessenhuis
Utrecht
3582 KE
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU) (The Netherlands)
University/education

Department of Surgery
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.