Safety of F14 Following Total Knee Replacement

Study Overview
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Brief Summary
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Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia

Official Title
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An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement

Conditions
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Analgesia

Intervention / Treatment
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* Drug: F14 (sustained release celecoxib)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or females indicated for primary, unilateral TKR Between 45-80 years of age Capable of giving signed informed consent Body Mass Index (BMI) ≤ 40 kg/m2 Medically stable as determined by the Investigator, based on physical examination, clinical laboratory tests, and 12-lead ECG findings, as well as medical history from subject and pre-study source documents from other care providers Absence of fixed flexion deformity exceeding 15deg Absence of varus or valgus deformity exceeding 15deg Minimum pre-operative flexion arc of 100deg American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3 Females of childbearing potential with a negative serum pregnancy test at screening or males with a partner that is of childbearing potential, who agree to employ adequate birth control measures for the full duration of the study Has undergone successful total knee replacement surgery, which in the opinion of the Investigator, will not affect the subject's study follow-up Exclusion Criteria: 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 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 Total or partial knee arthroplasty in the contralateral knee < 6 months prior to study surgery Participation or scheduled participation in another clinical study involving an investigational drug or device within 30 days before screening or during study follow-up Active or past infection in the index knee Documented osteonecrosis of the index knee within previous 12 months Other planned major surgery within 12 months of study surgery 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 Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis History of coronary or vascular stent placed within 3 months 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 Current medical diagnosis or subject-reported seizure disorder Current peripheral neuropathy History of complex regional pain syndrome (CRPS) Diagnosis of clinically significant liver hepatic and/or renal abnormalities within previous 2 years Diagnosis of diabetes with HbA1c ≥7% 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 Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of intervention (antipsychotic stable dosage established for >30 days will be allowed) Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary, or neurological Participation in active or pending personal injury or workers' compensation litigation

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F14 (sustained release celecoxib)<br>Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia | Drug: F14 (sustained release celecoxib)<br>* Celecoxib in BEPO® drug delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of treatment-emergent adverse events (TEAEs) |  | From Day 0 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, postoperative pain, NSAID, multimodal analgesia