Comparison of two techniques for reconstructing the anterior cruciate ligament with or without detachment from the tibia of the tendons used as grafts
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
• 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)
Lieu de l’étude
Bellinzona, Lugano
(BASEC)
Sponsor
Dr. med. Marco Delcogliano
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Marco Delcogliano
+41 (0)91 811 66 56
marco.delcogliano@cluttereoc.chENTE OSPEDALIERO CANTONALE
(BASEC)
Informations générales
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Informations générales
EOC - Unit Traumatologia e Ortopedia - ORL
(ICTRP)
Informations scientifiques
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Tessin
(BASEC)
Date d'approbation du comité d'éthique
22.10.2018
(BASEC)
Identifiant de l'essai ICTRP
NCT03746470 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament (ICTRP)
Maladie en cours d'investigation
Complete Tear, Knee, Anterior Cruciate Ligament (ICTRP)
Intervention étudiée
Procedure: ACL reconstruction preserving insertionProcedure: ACL reconstruction detaching insertion (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
30.10.2018 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
Clinical Trial Unit Ente Ospedaliero Cantonale (ICTRP)
Contacts supplémentaires
Marco Decogliano, MD;Marco Decogliano, MD, RicercaOrtopedia.ORL@eoc.ch, +41918117029, EOC - Unit? Traumatologia e Ortopedia - ORL, (ICTRP)
ID secondaires
ORL-ORT-003 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03746470 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible