Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

Exclusion Criteria

• •1. Significant arthritis in the surgical knee (Grade 3 or 4 on the Kellgren- Lawrence Grading Scale).
• •2. History of reactive synovial disease
• •3. History of a complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with sensory deficit of the lower extremities
• •4. History of fibromyalgia
• •5. Expected to undergo any of the following procedures concurrent with the meniscectomy:
• •* Meniscal repair procedure
• •* Patellar tendon debridement
• •* Patellar realignment
• •* Lateral or retinacular release
• •* Excision synovectomy (minor synovectomy to improve arthroscopic visualization is allowed)
• •* Concurrent ligamentous procedure
• •* Abrasion chondroplasty involving bone
• •* Microfracture
• •* Chondral transplantation
• •* Use of more than three portals
• •6. Known allergies to any of the individual ingredients in OMS103HP-S, other NSAIDs, aspirin, tricyclic antidepressants, or opioid analgesics
• •7. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• •8. Have a job-related claim(s) under dispute or mediation
• •9. History of drug or alcohol abuse
• •10. Treatment with an investigational drug or device within 30 days prior to the day of surgery
• •11. A clinically significant medical condition that in the opinion of the Investigator would put the subject at increased risk, impair the subject's ability to comply with the requirements of the protocol, or confound the interpretation of the data
• •12. Expected to receive a regional block for analgesia for this procedure
• •13. Considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug
• •14. The Investigator, employee of the investigative site, and/or part of the Investigator/employee's immediate families (defined as current spouse or partner, parent, natural or legally adopted child, stepchild living in the household, grandparent, or grandchild).