New shot could ease pain after knee surgery for days
NCT ID NCT04860635
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a single injection of F14, a long-acting form of the painkiller celecoxib, in 100 people undergoing total knee replacement. The goal is to see if it safely controls pain as part of a standard pain management plan. Participants receive the injection during surgery and are monitored for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- F14 (sustained release celecoxib)
- What this could lead to
- If it works, this could provide a longer-lasting pain relief option after knee replacement, reducing the need for frequent pain pills.
- What could go wrong
- This is an early-phase, single-arm study with no placebo group, so results may not prove effectiveness. The trial is currently suspended, and safety risks are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
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Panorama Orthopedics & Spine Center
Denver, Colorado, 80401, United States
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