Preservation technique of ruptured anterior cruciate ligament (ACL)
| ISRCTN | ISRCTN89368687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89368687 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/04/2011
- Registration date
- 24/05/2011
- Last edited
- 24/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stefan Eggli
Scientific
Scientific
Freiburgstrasse
Bern
3011
Switzerland
| stefaneggli@sonnenhof.ch |
Study information
| Study design | Single-centre prospective randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact kathrinaeschlimann@sonnenhof.ch to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Bern Cantonal Ethics Commission (Kantonale Ethikkommission Bern) (KEK) approved on 07/03/2009, KEK Ref.-Nr. KEK-BE: 048/09 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 patients |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Freiburgstrasse
Bern
3011
Switzerland
3011
Switzerland
Sponsor information
Swiss National Insurance Association (SUVA) (Switzerland)
Government
Government
SUVA - Fluhmattstrasse 1
Luzern
6002
Switzerland
| michael.braendle@sec.suva.ch | |
"ROR" |
https://ror.org/053ae3r23 |
Funders
Funder type
Government
Swiss National Insurance Association (SUVA) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
