Safety of F14 Following Total Knee Replacement

NCT04860635 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: 100-CIP03-P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Analgesia

Keywords

total knee arthroplasty; postoperative pain; NSAID; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

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

  From Day 0 to 12 months

Other Outcomes (4)

• NRS pain intensity

  From Day 1 to 3 months

• Duration of need for walking aids

  From Day 1 to 3 months

• Proportion of subjects using concomitant analgesics at any timepoint

  From Day 1 to 3 months

Study Arms (1)

F14 (sustained release celecoxib)

EXPERIMENTAL

Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia

Drug: F14 (sustained release celecoxib)

Interventions

F14 (sustained release celecoxib) DRUG

Celecoxib in BEPO® drug delivery system

F14 (sustained release celecoxib)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthritis Innovation Corporation: lead

Study Sites (2)

Panorama Orthopedics & Spine Center

Denver, Colorado, 80401, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Jared Foran, MD

  Panorama Orthopedics & Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 27, 2021
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)