Your session is about to expire
← Back to Search
Adrenergic Agonist
HTX-011 for Pain Management in Total Knee Replacement
Phase 4
Waitlist Available
Led By Matthew P Abdel, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presenting for primary total knee replacement for degenerative joint disease
Patient capable of providing their own informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72-hours postoperative total knee arthroplasty
Awards & highlights
Study Summary
This trial is comparing a new pain medication to the current standard to see if it's more effective.
Who is the study for?
This trial is for adults over 18 years old needing a primary total knee replacement due to joint disease, who can consent and have an ASA classification I to III. It's not for those with severe health issues like kidney injury, high opioid use, extreme obesity (BMI > 45), allergies to NSAIDs, cognitive impairments, or major illnesses such as advanced heart or liver diseases.Check my eligibility
What is being tested?
The study tests HTX-011 against standard pain control practices after knee surgery. HTX-011 is FDA-approved and may offer better pain management within the first 72 hours post-surgery compared to the usual mix of ropivacaine, epinephrine, ketorolac in saline.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, constipation from opioids typically used alongside these medications. There might also be risks related to individual components like allergic reactions or bleeding from NSAIDs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting a knee replacement due to arthritis.
Select...
I am able to understand and agree to the study's procedures and risks.
Select...
I am 18 or older with a health status that allows for safe surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72-hours postoperative total knee arthroplasty
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72-hours postoperative total knee arthroplasty
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain control at 72 hours
Secondary outcome measures
Distance walked at time of discharge with PT
Hospital length of stay
Opioid consumption
+2 moreSide effects data
From 2018 Phase 3 trial • 418 Patients • NCT0323748118%
Nausea
17%
Constipation
15%
Dizziness
13%
Headache
9%
Bradycardia
9%
Dysgeusia
8%
Skin odour abnormal
4%
Tremor
4%
Vomiting
2%
Tinnitus
1%
Incision site haematoma
1%
Chronic obstructive pulmonary disease
1%
Gamma-glutamyltransferase increase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group 1: HTX-011
Treatment Group 2: Bupivacaine HCI
Treatment Group 3: Saline Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HTX-011 Treatment GroupExperimental Treatment1 Intervention
Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia
Group II: Standard Block Control GroupActive Control1 Intervention
Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HTX-011
2019
Completed Phase 4
~2390
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,686 Total Patients Enrolled
Matthew P Abdel, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
154 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is higher than 45, which means you are very overweight.I have been taking strong painkillers daily for over a month.I am getting a knee replacement due to arthritis.I am able to understand and agree to the study's procedures and risks.I am 18 or older with a health status that allows for safe surgery.I am unable to give my own consent for medical procedures.I cannot have surgery due to kidney problems.I have a long-term pain condition.I do not have severe kidney, heart, or liver diseases.You have trouble with thinking and remembering things.I had a knee replacement on my other knee less than 2 years ago.You are allergic to any part of the study medications or have had severe allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs).
Research Study Groups:
This trial has the following groups:- Group 1: HTX-011 Treatment Group
- Group 2: Standard Block Control Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
What health conditions does HTX-011 commonly address?
"HTX-011 is commonly administered to patients requiring parenteral nutrition, and it may also provide relief for those suffering from synovitis, increased intra ocular pressure (IOP), and sympathetic ophthalmia."
Answered by AI
How many participants have been included in this research project thus far?
"At this moment, no additional participants are being sought for this trial. The study was initially published on February 7th 2022 and the last update occured December 1st of that same year. For those seeking to participate in other clinical trials, there are 41 total knee arthroplasty (TKA) studies as well as 306 HTX-011 evaluations actively recruiting patients."
Answered by AI
Are there currently opportunities for participants in this experiment?
"This trial is not accepting applications at the moment. First posted on February 7th 2022, and most recently updated December 1st of the same year, this clinical study does not require any further participants right now. However, there are currently 41 studies searching for patients with total knee arthroplasty (tka) and 306 active trials that need volunteers to test HTX-011."
Answered by AI
Has HTX-011 been granted authorization by the FDA?
"With HTX-011 having been approved in its Phase 4 trials, our evaluation yielded a rating of 3 with regards to safety."
Answered by AI
Has HTX-011 been subject to any other investigations in a clinical setting?
"As of now, 306 trials on HTX-011 are being conducted with 68 studies at Phase 3. While Boston, Massachusetts is the main hub for these researches, 673 sites globally have been enlisted to run experiments for this drug."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger