Use of an Osteoconductive Scaffold in ACL-Reconstruction (ACLROCS)

Sandro Fucentese

Status: Active, not recruiting

Conditions: ACL; ACL Injury; ACL - Anterior Cruciate Ligament Rupture

Treatments: Device: Hamstring tendon-only repair; Device: Osteoconductive scaffold-hamstring tendon composite repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03462823

W652

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Control treatment

Active Comparator group

Description:

ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.

Treatment:

Device: Hamstring tendon-only repair

Experimental treatment

Experimental group

Description:

ACL-reconstruction using hamstring autograft with hybrid fixation combined with the osteoconductive device under study.

Treatment:

Device: Osteoconductive scaffold-hamstring tendon composite repair