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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
326
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
CORE Orthopaedic Medical Center
Encinitas, California, United States
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minnesota Sports Medicine
Minneapolis, Minnesota, United States
University Orthopedics Center - Altoona
Altoona, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Texas Orthopedics
Austin, Texas, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States
...and 8 more locations
Improvement in knee function
Time frame: 30 days
Decreased pain
Time frame: 30 days
Improved range of motion
Time frame: 30 days
Earlier return to work
Time frame: 30 days
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