SuspendedPhase 2/3

Safety of F14 Following Total Knee Replacement

Stopped: Study superseded by alternative Phase 3 trial

United States100 participantsStarted 2026-09

Plain-language summary

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

Age range45 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Incidence and severity of treatment-emergent adverse events (TEAEs)

Timeframe: From Day 0 to 12 months

NCT IDNCT04860635

SponsorArthritis Innovation Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04

Who can participate

Age range45 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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