Randomized clinical study on the use of a bone substitute in the reconstruction of the anterior cruciate ligament
Zusammenfassung der Studie
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)
Untersuchte Intervention
Anterior cruciate ligament plastic surgery with bone growth-inducing bone substitute.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
Universitätsklinik Balgrist
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Sandro Fucentese
+41 44 386 12 83
knie@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Allgemeine Auskünfte
Head of Knee Surgery
(ICTRP)
Wissenschaftliche Auskünfte
Head of Knee Surgery
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.06.2017
(BASEC)
ICTRP Studien-ID
NCT03462823 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction (BASEC)
Wissenschaftlicher Titel
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction (ICTRP)
Öffentlicher Titel
Use of an Osteoconductive Scaffold in ACL-Reconstruction (ICTRP)
Untersuchte Krankheit(en)
ACL - Anterior Cruciate Ligament Rupture;ACL;ACL Injury (ICTRP)
Untersuchte Intervention
Device: Osteoconductive scaffold-hamstring tendon composite repair;Device: Hamstring tendon-only repair (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
29.12.2017 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Sandro Fucentese, Head of Knee Surgery (ICTRP)
Sekundäre IDs
W652 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03462823 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar