Use of an Osteoconductive Scaffold in ACL-Reconstruction

NCT ID: NCT03462823

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-29
• Study Completion Date: 2025-12-29

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.

Conditions

ACL - Anterior Cruciate Ligament Rupture; ACL; ACL Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control treatment

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

Group Type: ACTIVE_COMPARATOR

Hamstring tendon-only repair

Intervention Type: DEVICE

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

Experimental treatment

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

Group Type: EXPERIMENTAL

Osteoconductive scaffold-hamstring tendon composite repair

Intervention Type: DEVICE

The device under study is a composite bone substitute composed of a natural mineral matrix of bovine origin, reinforced with biodegradable synthetic polymers and natural collagen derivatives of bovine origin (smartbone, IBI S.A., Switzerland).

Interventions

Osteoconductive scaffold-hamstring tendon composite repair

The device under study is a composite bone substitute composed of a natural mineral matrix of bovine origin, reinforced with biodegradable synthetic polymers and natural collagen derivatives of bovine origin (smartbone, IBI S.A., Switzerland).

Intervention Type: DEVICE

Hamstring tendon-only repair

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandro Fucentese

OTHER

Sponsor Role: lead

Responsible Party

Sandro Fucentese

Head of Knee Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sandro Fucentese

Role: PRINCIPAL_INVESTIGATOR

Head of Knee Surgery

Locations

Balgrist University Hospital

Zurich, , Switzerland

Countries

Switzerland

References

Gotschi T, Hodel S, Kuhne N, Bachmann E, Li X, Zimmermann SM, Snedeker JG, Fucentese SF. Osteoconductive Scaffold Placed at the Femoral Tunnel Aperture in Hamstring Tendon ACL Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2023 Jun 5;11(6):23259671231174478. doi: 10.1177/23259671231174478. eCollection 2023 Jun.

Reference Type: DERIVED

PMID: 37347015 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W652

Identifier Type: -

Identifier Source: org_study_id