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 (PAI)?
An investigational perioperative injection being studied for pain control after total knee replacement surgery. It is designed to block nerve signals and reduce inflammation by combining a local anesthetic, epinephrine, and an NSAID.
Also referred to as Standard periarticular injection.
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
- The study compares a new drug, Zynrelef, with a standard knee injection and a nerve block to see if it can control pain after knee replacement surgery.
- Who it's for
- Adults scheduled for total knee replacement because of severe knee arthritis.
- What's involved
- Participants receive one of three pain‑control methods during surgery, then follow the same post‑surgery care and physical therapy. They will record pain levels and any pain medicines they use for several weeks.
- Time commitment
- The study lasts a few weeks after surgery, with regular follow‑up visits and pain‑score recordings.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Grosse Pointe Farms, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.