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Safety of F14 Following Total Knee Replacement

Phase 2
Suspended
Conditions
Analgesia
Interventions
Drug: F14 (sustained release celecoxib)
Registration Number
NCT04860635
Lead Sponsor
Arthritis Innovation Corporation
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
SUSPENDED
Sex
All
Target Recruitment
100
Inclusion Criteria
  1. Male and/or females indicated for primary, unilateral TKR
  2. Between 45-80 years of age
  3. Capable of giving signed informed consent
  4. Body Mass Index (BMI) ≤ 40 kg/m2
  5. 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
  6. Absence of fixed flexion deformity exceeding 15deg
  7. Absence of varus or valgus deformity exceeding 15deg
  8. Minimum pre-operative flexion arc of 100deg
  9. American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3
  10. 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
  11. 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
  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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
F14 (sustained release celecoxib)F14 (sustained release celecoxib)Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia
Primary Outcome Measures
NameTimeMethod
Incidence and severity of treatment-emergent adverse events (TEAEs)From Day 0 to 12 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Panorama Orthopedics & Spine Center

🇺🇸

Denver, Colorado, United States

Endeavor Clinical Trials

🇺🇸

San Antonio, Texas, United States

Panorama Orthopedics & Spine Center
🇺🇸Denver, Colorado, United States

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