Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic
surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma
initiates an acute inflammatory response, including swelling and pain, that leads to
restricted joint motion and loss of function. OMS103HP was designed to deliver targeted
therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit
inflammation and pain before they can begin.
The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving
knee function following ACL reconstruction. Secondary benefits being evaluated include
reduced postoperative pain, improvement in knee range of motion and earlier return to work.