Study Assessing Pain Relief After Replacement of the Knee

Launched by ALLAY THERAPEUTICS, INC. · Jan 24, 2025

Keywords

ClinConnect Summary

The ATX101-TKA-004 clinical trial is studying a new treatment called ATX101 to see if it can help relieve pain after knee replacement surgery. This trial will compare ATX101 to a saltwater solution (placebo) and bupivacaine, a standard pain relief medication, to find out which option works best for managing pain and how safe they are. Researchers will also look at how much opioid medication participants need after their surgery when taking ATX101 compared to the other treatments.

To participate, you should be between the ages of 18 and 75 and scheduled for a knee replacement due to arthritis. You must also be able to speak English or Spanish and agree to follow the trial rules. If you’ve had previous surgeries on the same knee or are planning any other surgeries, you might not be eligible. Participants will be closely monitored throughout the study, and they will need to keep a diary about their pain and medication use. This trial is currently recruiting, and anyone considering joining should discuss it with their doctor for more information.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Primary indication of TKA is knee pain due to osteoarthritis or post-traumatic arthritis
• • Scheduled to undergo primary unilateral TKA with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted)
• • American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2, or 3
• • Capable, able, and willing to comply with all trial visits and procedures. Participant must also be able to use trial required e-diary and demonstrate completion compliance during the screening period
• • English or Spanish speaking, willing, and capable of providing written informed consent
• Key Exclusion Criteria:
• • Has a planned concurrent surgical procedure (e.g. bilateral TKA) at the time of surgery or a planned surgical procedure before the last trial visit
• • Has had any previous open surgery, (e.g., ORIF for fracture, osteotomy, arthroplasty, unicompartmental knee arthroplasty, or TKA), in the trial knee at any time in the past or arthroscopic surgery within 12 months. Has had any previous surgery in the contralateral knee within 6 months prior to screening
• • Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee
• • Unable to abstain from opioid use for knee pain (including codeine) within 2 weeks (14 days) of surgery
• • Has a Body Mass Index (BMI) ≥45 kg/m²
• • Is unwilling or unable to discontinue use of medications or products that can impact pain control from the Screening Visit until the last trial visit (e.g. cannabidiol (CBD) oil, Kratom)
• • Has a medical condition or receiving medication such that, in the opinion of the Investigator, participating in the trial would pose a health risk to the participant or confound the postsurgical assessments or might confound or interfere with the outcome of the trial
• • Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines (approved or under emergency use authorization locally) are permitted if the participant is not in a clinical trial for the vaccine
• • Has a positive drug screen at the Screening Visit or on the day of surgery
• • Has participated in an ATX101 clinical trial
• • Pregnant, breastfeeding, or planning to become pregnant during the trial or before the last trial visit
• • Other protocol defined Inclusion/Exclusion criteria may apply