OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.
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. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Kerlan-Jobe Orthopaedic Clinic
Los Angeles, California, United States
Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)
Redwood City, California, United States
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States
The overall incidence of adverse events regardless of relationship to study drug.
Time frame: 90 days
Measures of safety and tolerability (e.g., clinical laboratory tests, physical examinations, etc.).
Time frame: 30 days
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