BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

Inclusion Criteria

• •1. Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
• •2. Meniscal injuries may be included
• •3. Isolated, unilateral anterior cruciate ligament injury.
• •4. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
• •5. Both male and non-pregnant female subjects will be included.
• •6. To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.
• •7. All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration.
• •3. Autograft anterior cruciate ligament surgery on either knee.
• •4. Anterior cruciate ligament injury on contra-lateral leg at any time
• •5. Multi-ligament reconstruction
• •6. Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician.
• •7. Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use.
• •8. Revision anterior cruciate ligament surgery to either knee at anytime
• •9. Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery.
• •10. Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.