Knee Injuries Clinical Trial
Official title:
A Prospective, Non-comparative Pilot Clinical Study of a Novel Xenograft Device for Reconstruction of the Anterior Cruciate Ligament.
To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population.
The OrthoPure™ XT device is a decellularized, sterile, single use biological scaffold for use
in the treatment of patients with a partial or complete tear of the Anterior Cruciate
Ligament (ACL) who require surgical reconstruction of the ACL.
This is a Pilot Safety Study. The primary objective of this study is to evaluate the clinical
safety of the OrthoPure™ XT device in a small group of patients that require reconstruction
of the Anterior Cruciate Ligament (ACL) due to partial or complete tear of the ACL.
Clinical safety will be analyzed through measurement of immune response (alpha-Gal IgG),
blood and urine analysis, incidence of secondary surgical interventions with the treated
knee, and the incidence of individual adverse events.
The second objectives of this study are to assess the efficacy endpoints, specifically:
improvement in knee stability, function and pain; improvement in patient quality of life and
radiographic analysis.
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