Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allay Therapeutics, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study Assessing Pain Relief After Replacement of the Knee
