Knee Injuries Clinical Trial
Official title:
A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair
The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is
taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver)
for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with
SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is
designed to be a temporary support structure to replace the torn ACL and to stabilize the
knee joint following surgical repair. It is designed to use the body's own healing process
to regenerate the patient's own new ligament tissue. As the new tissue grows and the support
structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by
the patient's body. The SeriACL device is designed to be installed with standard surgical
techniques for ACL repair.
This study is designed to test the safety of the SeriACL device in primary total ACL repair
in patients with a torn ACL. The study will evaluate whether repair of the ACL with the
SeriACL device will return the knee to normal function and what, if any, side effects will
occur.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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