Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/04/2011
Date assigned
24/05/2011
Last edited
24/05/2011
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

Prof Stefan Eggli

ORCID ID

Contact details

Freiburgstrasse
Bern
3011
Switzerland
stefaneggli@sonnenhof.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A single-centre, prospective, randomised controlled study comparing the common treatment of anterior cruciate ligament repair (semitendinosus grafting) to preservation and healing of the torn ligament using the dynamic intraligamentary stabilisation system

Acronym

Study hypothesis

This study compares in a prospective randomised trial a novel technique to preserve the ruptured anterior cruciate ligament in comparison to the established technique of replacing the torn ligament with a semitendinosus graft. Especially the stability of the knee is compared after 3, 6 and 12 months and the clinical outcome is measured using the IKDC and Lysholm score. The level of sportive activity is assessed according to the Tegner protocol.

Ethics approval

Bern Cantonal Ethics Commission (Kantonale Ethikkommission Bern) (KEK) approved on 07/03/2009, KEK Ref.-Nr. KEK-BE: 048/09

Study design

Single-centre prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact kathrinaeschlimann@sonnenhof.ch to request a patient information sheet

Condition

Anterior cruciate ligament (ACL) injury

Intervention

100 patients are subsequently operated after ACL injury. After a prospective randomisation the patient are either treated with an established semitendinosus transplant or with the new dynamic intraligamentary stabilisation technique.

The idea of the new technique is, that the torn ligament is preserved and brought to stable healing without replacement. Thereby a spring-screw mechanism, which is implanted into the tibia pulls the knee in a constant posterior translation. This internal stabilisation of the knee enables the ligament in combination with a microfracturing of the notch and PRF (platelet rich fibrin) induction to heal. Healing is measured 3, 6 and 12 months after surgery by magnetic resonance imaging (MRI) and mechanical translation measurement of the knee. Additionaly clinical and sportive outcome is measured using the Lyshom, IKDC and Tegner score.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Healing of ACL in magnetic resonance imaging (MRI)
2. Lysholm score, Tegner score, International Knee Documentation Committee (IKDC) score

Measured 3, 6 and 12 months after surgery.

Secondary outcome measures

1. Length of hospital stay
2. Time of rehabilitation
3. Satisfaction with results (VAS 0: completely unsatisfied, 10: completely sastisfied)

Overall trial start date

01/08/2009

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fresh ACL rupture (injury not older than 14 days)
2. Age under 45 years
3. No previous surgery on the injured knee
4. Regular participation in sports requiring pivoting of the knee joint

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients

Participant exclusion criteria

1. Age over 45
2. Previous injury to that knee, injury older than 14 days
3. Non-sportive patients (Tegner score less than 3)

Recruitment start date

01/08/2009

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Freiburgstrasse
Bern
3011
Switzerland

Sponsor information

Organisation

Swiss National Insurance Association (SUVA) (Switzerland)

Sponsor details

SUVA - Fluhmattstrasse 1
Luzern
6002
Switzerland
michael.braendle@sec.suva.ch

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Swiss National Insurance Association (SUVA) (Switzerland)

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

Publication citations

Additional files

Editorial Notes