Use of an Osteoconductive Scaffold in ACL-Reconstruction

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, 2020

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, 0041 44 510 74 34, [email protected]

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

April 2019