Status:
SUSPENDED
Safety of F14 Following Total Knee Replacement
Lead Sponsor:
Arthritis Innovation Corporation
Conditions:
Analgesia
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04860635
Start Date
September 1 2026
End Date
April 1 2028
Last Update
November 26 2025
Active Locations (2)
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1
Panorama Orthopedics & Spine Center
Denver, Colorado, United States, 80401
2
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229