Study Assessing Pain Relief After Replacement of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2025-10-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthroplasty (Postoperative Pain)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

surgical staff and pharmacist dispensing assigned treatment will not be blinded to the trial treatment

Study Groups

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ATX101

Group Type EXPERIMENTAL

ATX101

Intervention Type DRUG

ATX101 bupivacaine implants, total of 1,500 mg into the surgical site

saline placebo

Group Type PLACEBO_COMPARATOR

saline placebo

Intervention Type DRUG

normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration

bupivacaine hydrochloride

Group Type ACTIVE_COMPARATOR

bupivacaine hydrochloride

Intervention Type DRUG

bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration

Interventions

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ATX101

ATX101 bupivacaine implants, total of 1,500 mg into the surgical site

Intervention Type DRUG

bupivacaine hydrochloride

bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration

Intervention Type DRUG

saline placebo

normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No