Clinical trial for Osteoarthritis (OA) of the Knee
Official title Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT07775248
What this study is testing
What is Periarticular Injection?
Periarticular Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis (oa) of the knee.
Also referred to as Periarticular Injection (PAI).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with...
You likely can't join if
- Incomplete data in medical records
- Non-English speakers
- Chronic opioid use in the last 3 months
- Ipsilateral joint surgery in the last year
- Undergoing bilateral knee arthroplasty
- Cannot tolerate oral medications
See the full eligibility criteria
- Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with planned outpatient same-day discharge.
- Incomplete data in medical records
- Non-English speakers
- Chronic opioid use in the last 3 months
- Ipsilateral joint surgery in the last year
- Undergoing bilateral knee arthroplasty
- Cannot tolerate oral medications
- Swallowing difficulties
- Intolerance to acetaminophen, anti-inflammatories, muscle relaxants, gabapentinoids, or opioids/tramadol
- History of alcohol abuse
- Drug abuse
- Renal impairment
- Peptic ulcer disease
- GI bleeding
- Illicit narcotic usage in the past 6 months
- Chronic liver disease
- Chronic pain syndromes
The study team makes the final eligibility decision.
Where it's taking place
- Grosse Pointe Farms, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grosse Pointe Farms, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.