Total Knee Arthroplasty (Postoperative Pain)
Conditions
Keywords
postoperative pain, post-surgical pain total knee arthroplasty, bupivacaine, bupivacaine implant, total knee replacement, ATX101, TKA, post-operative pain, postsurgical pain, post-surgical pain, postsurgical pain total knee arthroplasty
Brief summary
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.
Interventions
DRUGATX101
ATX101 bupivacaine implants, total of 1,500 mg into the surgical site
DRUGbupivacaine hydrochloride
bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration
DRUGsaline placebo
normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration
Sponsors
Allay Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
surgical staff and pharmacist dispensing assigned treatment will not be blinded to the trial treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) for the Numerical Rating Scale at Rest (NRS-R) of pain intensity | from 30 minutes through 168 hours (Day 8) compared to placebo | NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC for the NRS-R of pain intensity | 30 minutes through 336 hours (Day 15) compared to placebo | NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10). |
| Total post-surgical consumption of opioid medications | from 30 minutes through 336 hours (Day 15) compared to placebo | — |
| Difference in NRS-A pain intensity scores during the Timed Up and Go (TUG) Test | at Day 15 compared to placebo | The NRS with activity (NRS-A) for pain intensity is an 11-item scale from 0 to 10 where participants rank the level of pain intensity after an activity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10). |
Countries
United States
Outcome results
None listed