Comparison of two techniques for reconstructing the anterior cruciate ligament with or without detachment from the tibia of the tendons used as grafts
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Bellinzona, Lugano
(BASEC)
Sponsor
Dr. med. Marco Delcogliano
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Marco Delcogliano
+41 (0)91 811 66 56
marco.delcogliano@cluttereoc.chENTE OSPEDALIERO CANTONALE
(BASEC)
Informazioni generali
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Informazioni generali
EOC - Unit Traumatologia e Ortopedia - ORL
(ICTRP)
Informazioni scientifiche
EOC - Unit? Traumatologia e Ortopedia - ORL,
+41918117029
marco.delcogliano@cluttereoc.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
22.10.2018
(BASEC)
ID di studio ICTRP
NCT03746470 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament (ICTRP)
Malattie studiate
Complete Tear, Knee, Anterior Cruciate Ligament (ICTRP)
Intervento studiato
Procedure: ACL reconstruction preserving insertionProcedure: ACL reconstruction detaching insertion (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
30.10.2018 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Clinical Trial Unit Ente Ospedaliero Cantonale (ICTRP)
Contatti aggiuntivi
Marco Decogliano, MD;Marco Decogliano, MD, RicercaOrtopedia.ORL@eoc.ch, +41918117029, EOC - Unit? Traumatologia e Ortopedia - ORL, (ICTRP)
ID secondari
ORL-ORT-003 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03746470 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile