Safety of F14 Following Total Knee Replacement

Exclusion Criteria

• •1. Known allergy or hypersensitivity to active ingredient celecoxib, OR known allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs when an allergy to celecoxib is unknown
• •2. Unwilling or unable to discontinue use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of scheduled surgery, or medical marijuana or cannabidiol (CBD) within 10 days
• •3. Total or partial knee arthroplasty in the contralateral knee \< 6 months prior to study surgery
• •4. Participation or scheduled participation in another clinical study involving an investigational drug or device within 30 days before screening or during study follow-up
• •5. Active or past infection in the index knee
• •6. Documented osteonecrosis of the index knee within previous 12 months
• •7. Other planned major surgery within 12 months of study surgery
• •8. Had a malignancy in the last year, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
• •9. Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis
• •10. History of coronary or vascular stent placed within 3 months
• •11. Suspected opioid abuse in the last 12 months with a score exceeding 5 on the DAST-10 questionnaire, and/or taking opioids on most days in the past three months, and currently taking \>120 mg morphine equivalent dose (MED) at least 5 days per week in the month prior to screening
• •12. Current medical diagnosis or subject-reported seizure disorder
• •13. Current peripheral neuropathy
• •14. History of complex regional pain syndrome (CRPS)
• •15. Diagnosis of clinically significant liver hepatic and/or renal abnormalities within previous 2 years
• •16. Diagnosis of diabetes with HbA1c ≥7%
• •17. Current inflammatory arthritides (e.g., rheumatoid arthritis, lupus erythematosus, ankylosing spondylitis, psoriatic arthritis), or traumatic bone injuries within 12 months before scheduled surgery, except for clinically stable/non-active gout that does not affect the knee and does not interfere with walking
• •18. Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of intervention (antipsychotic stable dosage established for \>30 days will be allowed)
• •19. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary, or neurological
• •20. Participation in active or pending personal injury or workers' compensation litigation