Your session is about to expire
← Back to Search
F14 for Postoperative Pain After Knee Replacement
Phase 3
Waitlist Available
Research Sponsored by Arthritis Innovation Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and/or females indicated for primary, unilateral total knee replacement (TKR)
Absence of moderate to severe varus or valgus deformity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will test a single-dose drug to reduce pain after knee replacement surgery, while also evaluating its safety.
Who is the study for?
Adults aged 45-80, with a BMI ≤ 40 kg/m2, scheduled for unilateral total knee replacement surgery can join. They must have stable health as confirmed by tests and no recent injections or major surgeries in the affected knee. Women of childbearing age need a negative pregnancy test and agree to birth control measures.Check my eligibility
What is being tested?
The trial is testing F14 (a sustained release form of celecoxib) combined with standard pain management against standard treatment alone after knee replacement surgery. It's randomized and double-blind, meaning neither patients nor doctors know who gets which treatment.See study design
What are the potential side effects?
Possible side effects include those typical of NSAIDs like celecoxib: stomach upset, increased risk of bleeding, kidney issues, and allergic reactions. The study will monitor safety closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a first-time knee replacement on one knee.
Select...
My knees do not have severe inward or outward bending.
Select...
My health is good enough for surgery according to the ASA score.
Select...
I do not have a severe permanent bend in my joints.
Select...
I haven't had injections in my knee for 3 months before my planned surgery.
Select...
I can bend my joint through a range of 100 degrees.
Select...
I am between 45 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Knee
Proportion of subjects using opioid rescue medication at 2 weeks
Pain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: F14 + Multimodal AnalgesiaExperimental Treatment4 Interventions
Group II: Multimodal AnalgesiaActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methocarbamol
2016
Completed Phase 4
~480
Acetaminophen
2017
Completed Phase 4
~2030
Find a Location
Who is running the clinical trial?
Arthritis Innovation CorporationLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Postoperative Pain
20 Patients Enrolled for Postoperative Pain
AllucentUNKNOWN
3 Previous Clinical Trials
152 Total Patients Enrolled
Matthew Shive, PhDStudy DirectorArthritis Innovation Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of heavy drinking within the past year.I was diagnosed with bone tissue death in the last year.You are currently involved in a legal case related to an injury to your knee.My knees do not have severe inward or outward bending.My health is good enough for surgery according to the ASA score.I do not have a severe permanent bend in my joints.I have hardware in my knee from a past surgery that won't affect new knee surgery.I haven't had injections in my knee for 3 months before my planned surgery.I haven't had major knee surgery except simple arthroscopy in the past year.I have sleep apnea treated with CPAP or BIPAP and had postoperative delirium before.I am scheduled for a first-time knee replacement on one knee.I am using or willing to use birth control during the study.I do not have active inflammatory arthritis or recent bone injuries.I have had significant liver or kidney issues in the last 2 years.I can stop taking neuropathic pain medication like pregabalin or gabapentin 7 days before and for 3 months after the study surgery.I can stop using marijuana or CBD for the required time before and after surgery.I cannot stop taking opioid painkillers 7 days before surgery.I have pain in areas other than the study knee that needs painkillers.I have used opioids heavily in the past year and currently take a high dose.I haven't taken immunosuppressants or certain mental health/nerve medications in the last month, or I've been on a stable dose for over a month.You have tested positive for a medication in your urine that you are not allowed to take before your surgery.My health is stable according to recent tests and doctor's review.I have a serious health condition that could make surgery riskier.I cannot stop taking NSAIDs for 7 days before and 6 weeks after the surgery.I am allergic to opioids, NSAIDs, or acetaminophen.I have had or currently have an infection in my knee.I have been diagnosed with or experience seizures.I do not have any major surgeries planned within a year after the study surgery.I haven't had cancer in the last year, except for specific non-spreading skin cancers or localized cervical cancer.I can bend my joint through a range of 100 degrees.I am allergic to celecoxib or sulfa drugs.Your score on the Anxiety Sensitivity Index is higher than 40.I have diabetes with an HbA1c level of 7 or higher.I have not had knee replacement surgery on my other knee within the last 6 months.I am experiencing numbness, tingling, or pain in my hands or feet.I am between 45 and 80 years old.Your body mass index (BMI) is less than or equal to 40.My other knee's pain level is 4 or higher.I have been diagnosed with a skin condition such as psoriasis or chronic ulcers.You have had a stent placed in your heart or blood vessels within the last 3 months.I have a history of complex regional pain syndrome.My mood or anxiety is stable, with a PHQ-9 score of 14 or less.You have a high fear of pain score.
Research Study Groups:
This trial has the following groups:- Group 1: F14 + Multimodal Analgesia
- Group 2: Multimodal Analgesia
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment seek out senior citizens as participants?
"In order to qualify for this particular clinical trial, patients must be aged between 45 and 80. There are 77 other trials that cater exclusively to patients under 18 and 413 for those above 65."
Answered by AI
does the FDA sanction F14 + Multimodal Analgesia?
"F14 + Multimodal Analgesia is currently in Phase 3 trials, meaning that there is evidence of efficacy as well as multiple rounds of data supporting its safety. Our team at Power scores it a 3 on the 1-3 scale."
Answered by AI
Are participants currently being enrolling in this experiment?
"Unfortunately, this particular trial is no longer recruiting patients. According to the information available on clinicaltrials.gov, this study was first posted on November 1st 2022 and had its last update on October 28th of the same year. However, there are 539 other trials that may be a better fit for you."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger