Randomized clinical study on the use of a bone substitute in the reconstruction of the anterior cruciate ligament
Descrizione riassuntiva dello studio
The anterior cruciate ligament stabilizes the knee joint together with the posterior cruciate ligament. Through this guidance, other structures of the knee joint, such as menisci and cartilage, are protected from destruction. Ruptures of the ligament often occur in sports that involve rapid changes of direction and in the field of alpine skiing. For the reconstruction of the anterior cruciate ligament, autologous material is usually used as a graft. For this purpose, the middle third of the patellar tendon is harvested along with a small bone block from the patella and the tibia. Alternatively, flexor tendons on the inner side of the knee joint (semitendinosus or gracilis tendon) can also be used as a graft. The graft is fixed using knee arthroscopy in drill channels in the femur or tibia with the help of screws or pins. The use of the patellar tendon offers the advantage of accelerated incorporation of the graft into the drill channel. However, pain and patellar fractures may occur at the harvesting site. Since no bone block is harvested when using a flexor tendon, its harvesting is less problematic, but the healing process in the drill channel is often more prolonged. The medical device to be tested consists of a bone growth-inducing bone substitute. This is intended to accelerate the incorporation of the flexor tendon graft into the drill channel. The bone substitute is threaded into the tendon graft and lies at the joint-proximal end of the drill channel in the femur. In a total of 56 patients, the healing process after cruciate ligament reconstruction with the technique to be studied will be compared with the conventional method. The occurrence of any complications, the ossification of the drill channel (radiological examinations), the healing process, as well as patient satisfaction and knee stability over 5 years will be investigated.
(BASEC)
Intervento studiato
Anterior cruciate ligament plastic surgery with bone growth-inducing bone substitute.
(BASEC)
Malattie studiate
Reconstruction of the anterior cruciate ligament in case of rupture
(BASEC)
18 to 60 years of age. Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the ACL. Informed consent as documented by signature (BASEC)
Criteri di esclusione
Multi-ligament reconstruction. Prior ACL reconstruction or other surgical procedure on the affected knee or prior fracture of the affected leg. Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.) or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or medical condition or comorbidity that would interfere with study participation. (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Universitätsklinik Balgrist
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Sandro Fucentese
+41 44 386 12 83
knie@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Informazioni generali
Head of Knee Surgery
(ICTRP)
Informazioni scientifiche
Head of Knee Surgery
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
16.06.2017
(BASEC)
ID di studio ICTRP
NCT03462823 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction (BASEC)
Titolo accademico
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction (ICTRP)
Titolo pubblico
Use of an Osteoconductive Scaffold in ACL-Reconstruction (ICTRP)
Malattie studiate
ACL - Anterior Cruciate Ligament Rupture;ACL;ACL Injury (ICTRP)
Intervento studiato
Device: Osteoconductive scaffold-hamstring tendon composite repair;Device: Hamstring tendon-only repair (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 60 Years
Minimum age: 18 Years
Inclusion
- Acute unilateral complete tear of the ACL that occurred within 18 weeks before
planned surgery and requires reconstruction of the
- Informed consent as documented by signature
Exclusion Criteria:
- Prior ACL reconstruction or other surgical procedure on the affected knee.
- Prior fracture of the affected leg.
- Multi-ligament reconstruction.
- Previous or current ACL injury on contra-lateral leg.
- Medical condition or comorbidity that would interfere with study participation.
- The patient is mentally compromised.
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant.
- Other clinically significant concomitant disease states (e.g. renal failure, hepatic
dysfunction, cardiovascular disease, etc.). (ICTRP)
non disponibile
Endpoint primari e secondari
Bone tunnel volume (ICTRP)
IKDC Subjective Knee Evaluation Form;Lysholm Knee Scoring Scale;Tegner Activity Scale;KT-1000 Arthrometer Test;Lachmann Test;Pivot shift test;Bone tunnel width;Osteoconductive scaffold-bone integration (ICTRP)
Data di registrazione
29.12.2017 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Sandro Fucentese, Head of Knee Surgery (ICTRP)
ID secondari
W652 (ICTRP)
Risultati-Dati individuali dei partecipanti
No (ICTRP)
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03462823 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile