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