Condition category
Musculoskeletal Diseases
Date applied
27/09/2006
Date assigned
27/09/2006
Last edited
25/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Surgery
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor type

University/education

Website

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

Design in: http://www.ncbi.nlm.nih.gov/pubmed17986319
Results in: http://www.ncbi.nlm.nih.gov/pubmed/18645042

Publication citations

  1. 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.

Additional files

Editorial Notes