Comparison of two techniques for reconstructing the anterior cruciate ligament with or without detachment from the tibia of the tendons used as grafts
Zusammenfassung der Studie
The study aims to compare two different surgical techniques for the reconstruction of the anterior cruciate ligament (ACL) in arthroscopy, both performed in normal clinical practice. The reconstruction procedure involves replacing the injured ACL with a portion of tendons taken from two thigh muscles of the same operated patient. These tendons (referred to as semitendinosus and gracilis) are used as a graft, meaning they are taken from the thigh muscle and transferred to the knee for ligament reconstruction. This study intends to evaluate whether the reconstruction of the ACL performed while maintaining the insertion of the tendons on the tibia improves the transformation process of the tendon used as a graft into the new ligament and its positioning within the knee structure, compared to the reconstruction of the ACL performed by detaching the tendons from their insertion. Furthermore, it will be assessed whether this improvement is also associated with a better clinical and functional outcome.
(BASEC)
Untersuchte Intervention
1. The surgeon harvests the tendons by completely detaching them from their insertion point on the tibia (bone of the leg). 2. The surgeon harvests the tendons while maintaining their insertion on the tibia, meaning he uses them for reconstruction without detaching them from the bone.
(BASEC)
Untersuchte Krankheit(en)
anterior cruciate ligament
(BASEC)
• Age between 16 and 60 years, of both sexes • Presence of a primary total ACL injury of traumatic origin documentable by MRI • Surgical indication for ACL reconstruction in arthroscopy • Written informed consent • Subjects capable of understanding and willing • Active and non-sedentary lifestyle (BASEC)
Ausschlusskriterien
• Complex associated meniscal injuries • Associated cartilage injuries larger than > 2 cm2 • Other associated ligament injuries • Axis deviations greater than 10° • Rheumatic, neuromuscular, or general systemic diseases • Previous surgically treated knee trauma • Obvious difficulties and compliance in following rehabilitation programs • Obesity (BMI ≥ 30) • Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients (BASEC)
Studienstandort
Bellinzona, Lugano
(BASEC)
Sponsor
Dr. med. Marco Delcogliano
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Marco Delcogliano
+41 (0)91 811 66 56
marco.delcogliano@cluttereoc.chENTE OSPEDALIERO CANTONALE
(BASEC)
Allgemeine Auskünfte
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Allgemeine Auskünfte
EOC - Unit Traumatologia e Ortopedia - ORL
(ICTRP)
Wissenschaftliche Auskünfte
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
22.10.2018
(BASEC)
ICTRP Studien-ID
NCT03746470 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A randomized controlled trial to evaluate the graft ligamentization and integration in the reconstruction of the anterior cruciate ligament with or without detachment of hamstring tendon tibial insertion (BASEC)
Wissenschaftlicher Titel
A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion (ICTRP)
Öffentlicher Titel
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament (ICTRP)
Untersuchte Krankheit(en)
Complete Tear, Knee, Anterior Cruciate Ligament (ICTRP)
Untersuchte Intervention
Procedure: ACL reconstruction preserving insertionProcedure: ACL reconstruction detaching insertion (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Age between 18 and 55
- MRI confirmed primary and total ACL injury of traumatic origin
- Indication for ACL reconstruction in arthroscopy
- Written informed consent
- Active and non-sedentary lifestyle
Exclusion Criteria:
- Complex meniscal injuries
- Cartilage lesions of sizes> 2 cm2
- Other ligamentous lesions
- Axis deviations greater than 10
- Rheumatic, neuromuscular or general systemic diseases
- Prevention of injured knee traumas treated surgically
- Difficulties in compliance in following the rehabilitation programs
- Obesity (BMI = 30)
- Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases,
autoimmune diseases, immunocompromised patients (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Graft integration by the Signal / Noise Quotient (SNQ) at 6 months (ICTRP)
Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months;Right anatomical graft position;Anterior tibial translation;Anterior knee joint instability;IKDC (International Knee Documentation Committee) questionnaire;Tegner activity scale (ICTRP)
Registrierungsdatum
30.10.2018 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Clinical Trial Unit Ente Ospedaliero Cantonale (ICTRP)
Weitere Kontakte
Marco Decogliano, MD;Marco Decogliano, MD, RicercaOrtopedia.ORL@eoc.ch, +41918117029, EOC - Unit? Traumatologia e Ortopedia - ORL, (ICTRP)
Sekundäre IDs
ORL-ORT-003 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03746470 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar