Osteoarthritis (OA) of the KneePhase 4NCT07219888
Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty
A Phase 4 study testing oral suzetrigine and oral Oxycodone in people with Osteoarthritis (OA) of the Knee, run by University of Louisville at 1 site in United States.
Trial summary
The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- oral suzetrigine and oral Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 30 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Who cannot join
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- Contraindication or Hypersensitivity to suzetrigine
- Pregnant or nursing females
- Patient has taken opioids within the 90 days prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.
Read the detailed description
The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty.
The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures.
The main questions it aims to answer are:
- What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty.
Participants will:
- be randomized into one of two groups
- undergo a primary TKA
- complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
- return to office at 2 weeks and 6 weeks postop for follow-up
- complete additional questionnaires at 2 weeks and 6 weeks postop
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- oral suzetrigine, oral Oxycodone
- Keywords
- osteoarthritis, knee, total knee arthroplasty, prospective RCT, postoperative analgesia, postoperative pain management
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral suzetrigineDrug
patient receives a two-week supply of oral suzetrigine upon discharge
oral OxycodoneDrug
Patient will receive a two-week supply of oral Oxycodone upon discharge
| Study group | Role | What they receive |
|---|---|---|
| Group A: suzetrigine group | Experimental | Participant will receive a two-week supply of oral suzetrigine upon discharge. Participant will also receive a 10-pill supply of Oxycodone as a rescue medication. Receives: Drug: oral suzetrigine |
| Group B: Oxycodone group | Active comparator | Participant will receive a two-week supply of oral Oxycodone upon discharge Receives: Drug: oral Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Opioid Use POD 1-14
Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
Measured: 2 weeks
total opioid usage over two weeks
total daily opioid usage (as measured in MME) for the first 14 days following TKA
Measured: 2 weeks
Use of supplemental opioid POD 1-14
Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
Measured: 2 weeks
VAS pain score over two weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10
Measured: 2 weeks
Opioid Usage at 6 weeks postop
Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
Measured: 6 weeks
Secondary outcomes (3)
VAS Pain Score at 6 weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain at 6 weeks following TKA. Scale 0-10
Measured: 6 weeks
KOOS, JR.
The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. Scoring scale 0-100.
Measured: preoperatively and 6 weeks (± 2 weeks) postoperatively
ROM
active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion
Measured: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start9 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized cohort analysis study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
- Investigators
- Rodolfo Zamora, MD, Study chair, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219888
- Sponsor's protocol ID
- 25.0688
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share IPD if it is not a requirement
Publications
Mach M, Giba A, Miedziaszczyk M, Bryla A, Szkutnik-Fiedler D. Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain Management: A Review of Clinical Evidence and Therapeutic Perspectives. Cureus. 2025 Aug 22;17(8):e90755. doi: 10.7759/cureus.90755. eCollection 2025 Aug.
PubMed 40862032The Lancet Regional Health-Americas. Opioid crisis: addiction, overprescription, and insufficient primary prevention. Lancet Reg Health Am. 2023 Jul 12;23:100557. doi: 10.1016/j.lana.2023.100557. eCollection 2023 Jul. No abstract available.
PubMed 37497399Robert M, Jouanjus E, Khouri C, Fouilhe Sam-Lai N, Revol B. The opioid epidemic: A worldwide exploratory study using the WHO pharmacovigilance database. Addiction. 2023 Apr;118(4):771-775. doi: 10.1111/add.16081. Epub 2022 Nov 22.
PubMed 36331523
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT07219888
- Acronym / sponsor ID
- 25.0688
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, knee, total knee arthroplasty, prospective RCT, postoperative analgesia, postoperative pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.
Detailed description
The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty.
The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures.
The main questions it aims to answer are:
- What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty.
Participants will:
- be randomized into one of two groups
- undergo a primary TKA
- complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
- return to office at 2 weeks and 6 weeks postop for follow-up
- complete additional questionnaires at 2 weeks and 6 weeks postop
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized cohort analysis study
| Arm | Type | Receives |
|---|---|---|
| Group A: suzetrigine group | Experimental | Drug: oral suzetrigineParticipant will receive a two-week supply of oral suzetrigine upon discharge. Participant will also receive a 10-pill supply of Oxycodone as a rescue medication. |
| Group B: Oxycodone group | Active comparator | Drug: oral OxycodoneParticipant will receive a two-week supply of oral Oxycodone upon discharge |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Key exclusion criteria (6 listed)
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- Contraindication or Hypersensitivity to suzetrigine
- Pregnant or nursing females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral suzetriginepatient receives a two-week supply of oral suzetrigine upon discharge | Drug | Group A: suzetrigine group |
| oral OxycodonePatient will receive a two-week supply of oral Oxycodone upon discharge | Drug | Group B: Oxycodone group |
Primary outcome
Daily Opioid Use POD 1-14
Time frame: 2 weeks
Daily opioid use as measured in MME recorded daily for the first two weeks following TKA
total opioid usage over two weeks
Time frame: 2 weeks
total daily opioid usage (as measured in MME) for the first 14 days following TKA
Use of supplemental opioid POD 1-14
Time frame: 2 weeks
Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)
VAS pain score over two weeks
Time frame: 2 weeks
VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10
Opioid Usage at 6 weeks postop
Time frame: 6 weeks
Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage
3 secondary outcomes
VAS Pain Score at 6 weeks
Time frame: 6 weeks
KOOS, JR.
Time frame: preoperatively and 6 weeks (± 2 weeks) postoperatively
ROM
Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 40862032Mach M, Giba A, Miedziaszczyk M, Bryla A, Szkutnik-Fiedler D. Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain Management: A Review of Clinical Evidence and Therapeutic Perspectives. Cureus. 2025 Aug 22;17(8):e90755. doi: 10.7759/cureus.90755. eCollection 2025 Aug.
- Results publication: PubMed 37497399The Lancet Regional Health-Americas. Opioid crisis: addiction, overprescription, and insufficient primary prevention. Lancet Reg Health Am. 2023 Jul 12;23:100557. doi: 10.1016/j.lana.2023.100557. eCollection 2023 Jul. No abstract available.
- Results publication: PubMed 36331523Robert M, Jouanjus E, Khouri C, Fouilhe Sam-Lai N, Revol B. The opioid epidemic: A worldwide exploratory study using the WHO pharmacovigilance database. Addiction. 2023 Apr;118(4):771-775. doi: 10.1111/add.16081. Epub 2022 Nov 22.
- Individual participant dataSharing planned: No. Will not share IPD if it is not a requirement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodolfo Zamora, MD study chair
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral suzetrigine and oral Oxycodone in people with Osteoarthritis (OA) of the Knee, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Opioid Use POD 1-14 (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07219888, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.