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Use of an Osteoconductive Scaffold in ACL-Reconstruction — ACLROCS  

ACL Injury Clinical Trial

Official title:
Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

  • ACL
  • ACL - Anterior Cruciate Ligament Rupture
  • ACL Injury
  • Anterior Cruciate Ligament Injuries
  • Rupture
Clinical Trial Details
NCT number NCT03462823
Study type Interventional
Source Balgrist University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date August 29, 2017
Completion date April 29, 2024
View Details
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