Use of an Osteoconductive Scaffold in ACL-Reconstruction
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.
Reconstruction of the anterior cruciate ligament (ACL) using autograft tissue is currently recommended as the standard of care following an ACL tear or rupture, with the bone-tendon-bone (BTB) graft and hamstring tendon graft the most common. Although a BTB autograft is widely recognized to offer high mechanical performance and rapid graft healing, these advantages come at the cost of a longer surgery time and higher risk of severe patient discomfort at the graft harvest site. Use of a hamstring tendon autograft is less painful, but is generally slower to heal with higher risk of mechanical graft failure due to poor bone ingrowth. The aim of the current study is to augment graft-to-bone incorporation by use of an osteoconductive scaffold enlaced into the hamstring tendon autograft. This bovine derived composite bone substitute is inserted into the articular aperture of the femoral bone tunnel and should provide an osteoconductive / osteoinductive environment at a biomimetic attachment site leading to improved secondary graft-fixation and a reduced incidence of tunnel widening. Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique. Secondary objectives aim to assess the clinical outcome of the interventional treatment including patient subjective knee function and objective measures of knee stability.
Bone tunnel volume
IKDC Subjective Knee Evaluation Form
ACL - Anterior Cruciate Ligament Rupture
Osteoconductive scaffold-hamstring tendon composite repair
Study Arms / Comparison Groups
Description: ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 29, 2017
April 29, 2024
Primary Completion Date
June 29, 2021
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.).
18 Years - 60 Years
Accepts Healthy Volunteers
Sandro Fucentese, ,
Sandro Fucentese, Principal Investigator, Head of Knee Surgery