Clinical trial NCT04860635: Safety of F14 Following Total Knee Replacement
Official title: An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Analgesia
Keywords: total knee arthroplasty
postoperative pain
NSAID
multimodal analgesia
Lead sponsor: Arthritis Innovation Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: From Day 0 to 12 months
Secondary outcomes:
Other outcomes:
measure: NRS pain intensity
timeFrame: From Day 1 to 3 months
measure: Duration of need for walking aids
timeFrame: From Day 1 to 3 months
measure: Proportion of subjects using concomitant analgesics at any timepoint
timeFrame: From Day 1 to 3 months
measure: Celecoxib concentration in plasma
timeFrame: At specified timepoints up to 3 months
Locations:
city: Denver
country: United States
facility: Panorama Orthopedics & Spine Center
state: Colorado
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
Study officials:
affiliation: Panorama Orthopedics & Spine Center
name: Jared Foran, MD
role: PRINCIPAL_INVESTIGATOR
References: