Brief Title
Use of an Osteoconductive Scaffold in ACL-Reconstruction
Official Title
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Bone tunnel volume
Secondary Outcome
IKDC Subjective Knee Evaluation Form
Condition
ACL - Anterior Cruciate Ligament Rupture
Intervention
Osteoconductive scaffold-hamstring tendon composite repair
Study Arms / Comparison Groups
Control treatment
Description: ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
56
Start Date
August 29, 2017
Completion Date
April 29, 2024
Primary Completion Date
June 29, 2021
Eligibility Criteria
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.).
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Sandro Fucentese, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT03462823
Organization ID
W652
Responsible Party
Sponsor-Investigator
Study Sponsor
Sandro Fucentese
Study Sponsor
Sandro Fucentese, Principal Investigator, Head of Knee Surgery
Verification Date
July 2020