Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male and/or female indicated for primary, unilateral TKR
Between 45-80 years of age inclusive at the time of signing the informed consent
Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Body Mass Index (BMI) ≤ 40 kg/m²
Medically stable as determined by the Investigator based on pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
Absence of fixed flexion deformity exceeding 15°
Absence of varus or valgus deformity exceeding 15°
Minimum pre-operative flexion arc of 100°
Absence of steroid, hyaluronic acid, platelet rich plasma, or any other type of therapeutic injection(s) in the index knee within 3 months before scheduled surgery
American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3
Females of childbearing potential with a negative pregnancy test at screening, who agree to employ adequate birth control measures for the full duration of the study
Has undergone scheduled total knee replacement surgery of the index knee, which in the opinion of the Investigator, will not affect the participant's study follow-up

Exclusion Criteria:

Allergy or hypersensitivity to active ingredient celecoxib. When an allergy to celecoxib is unknown,allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs
Active or past infection in the index knee
Previous total or partial knee arthroplasty in either knee within the past 6 months
Prior arthroscopy in the index knee in the last 6 months; knee surgery other than arthroscopy (including cruciate ligament, cartilage or osteotomy) in the index knee in the last 12 months; knee surgery in the contralateral knee in the last 12 months (excluding total or partial knee replacement)
Documented osteonecrosis or arthrotomy within previous 12 months
Prior or current presence of hardware in index knee other than screws from previous ligament repair that do not require manipulation or removal for TKR surgery
Other planned major surgery within 12 months of scheduled surgery
Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the TKR surgery emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) or back (by body diagram)
Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate or affect the participant's study follow-up
Strong narcotic use (e.g. Oxycontin®, Vicodin®, Percocet®) before scheduled study surgery for a prolonged period exceeding 30 days within the last 2 years
History of alcohol abuse within previous 12 months (score of 4 on CAGE questionnaire)
Known or suspected history of illicit drug abuse within 1 year before randomization, or history of opioid dependence within 2 years before scheduled surgery (score exceeding 5 on DAST-10 questionnaire)
Participation in another clinical study involving an investigational product (IP) or device within 30 days before screening or scheduled participation in another clinical study involving an IP or device during the course of this study
Use of pregabalin or gabapentin, or other drugs for neuropathic pain unless willing to discontinue at least 7 days prior to study surgery
Current patient-reported seizure disorder
Current peripheral neuropathy
Current depression, mood or anxiety disorder (score exceeding 14 on PHQ-9 questionnaire)
History of complex regional pain syndrome (CRPS)
Diagnosis of clinically significant liver and/or renal abnormalities within previous 2 years
Diagnosis of diabetes with HbA1c exceeding 7
Current inflammatory arthritides (e.g., rheumatoid arthritis, lupus erythematosus, ankylosing spondylitis, psoriatic arthritis), or traumatic bone injuries within 12 months before scheduled surgery, but excepting clinically stable/non-active gout that does not affect the knee and does not interfere with walking
Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of randomization
Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis
Participants with sleep apnea associated with a history of postoperative delirium. If symptomatic sleep apnea is currently treated with continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP), use must be continued postoperatively
History of coronary or vascular stent placed within 3 months (may be extended to 1 year if medically indicated per physician discretion).
Participation in active or pending personal injury or workers' compensation litigation related to index knee
Current or planned use of medical marijuana or cannabidiol (CBD), unless willing to discontinue at least 10 days prior to study surgery and for 3 months following study surgery
Unwilling or unable to discontinue use of NSAIDs within 7 days of scheduled surgery and for 3 months following study surgery, including low-dose aspirin for cardiac prophylaxis
Has an allergy or contraindication to opioids
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
Positive urine drug screen for disallowed medication at screening or preoperatively on day of study surgery