Thumb Basal Joint OsteoarthritisNCT07723352
Journavx to Treat Pain After Thumb Basal Joint Arthroplasty
An observational study of Thumb Basal Joint Osteoarthritis and Postoperative Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thumb Basal Joint Osteoarthritis, Postoperative Pain, Joint Replacement Surgery
- What is being tested?
- suzetrigine 100mg and Acetaminophen
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to 31 Dec 2028
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants Undergoing thumb basal joint arthroplasty (BJA) at Rothman Orthopaedic Institute
Who may be able to join
- Aged 40-80 years.
- Undergoing thumb basal joint arthroplasty (BJA)
- Able to provide informed consent.
- Willing to comply with the study procedures.
Who cannot join
- History of substance abuse or chronic opioid use.
- Known allergies to acetaminophen, oxycodone, or suzetrigine.
- Severe renal or hepatic dysfunction
- Estimated glomerular filtration rate less than 15 ml/min/1.73m^2
- History of kidney transplant
- Child-Pugh Class C
Show all 12Show fewer
- History of liver failure
- Active hepatitis that can adversely influence hepatic function
- Has had prior surgery on the study hand within the last 6 months
- Is currently pregnant, planning to be pregnant, or breastfeeding
- Use of strong or moderate CYP3A inhibitors or inducers, or medications known to interact with suzetrigine
- Currently using a prescription pain medication other study medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty
The purpose of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications.
- Conditions
- Thumb Basal Joint Osteoarthritis, Postoperative Pain, Joint Replacement Surgery, Joint Replacement
- Being tested
- suzetrigine 100mg, Acetaminophen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suzetrigine 100mgDrug
Participants will receive the recommended dosing for suzetrigine, which consists of a 100 mg oral loading dose taken in the recovery room prior to discharge, followed by 50 mg doses taken orally every 12 hours for 5 days, totaling 11 doses.
AcetaminophenDrug
As part of the multimodal pain regimen, participants will also receive acetaminophen (Tylenol) (500 mg, every 4 hours, or 1000 mg, every 8 hours)
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing thumb Basal Joint Replacement Surgery | Participants undergoing thumb Basal Joint Replacement Surgery receive suzetrigine (100 mg loading dose followed by 50 mg every 12 hours for 5 days) in combination with acetaminophen (Tylenol). Receives: Drug: suzetrigine 100mg; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Participants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start21 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb Basal Joint OsteoarthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tnicholson, Rothman Institute Orthopaedics
- Investigators
- Camilo Restrepo, MD, Study director, Rothman Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723352
- Sponsor's protocol ID
- AILY2025-1283
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT07723352
- Acronym / sponsor ID
- AILY2025-1283
- Conditions
- Thumb Basal Joint Osteoarthritis, Postoperative Pain, Joint Replacement Surgery, Joint Replacement
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 21 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jul 2026 (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 of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing thumb Basal Joint Replacement Surgery | – | Drug: suzetrigine 100mg, Drug: AcetaminophenParticipants undergoing thumb Basal Joint Replacement Surgery receive suzetrigine (100 mg loading dose followed by 50 mg every 12 hours for 5 days) in combination with acetaminophen (Tylenol). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants Undergoing thumb basal joint arthroplasty (BJA) at Rothman Orthopaedic Institute
Key inclusion criteria (4 listed)
- Aged 40-80 years.
- Undergoing thumb basal joint arthroplasty (BJA)
- Able to provide informed consent.
- Willing to comply with the study procedures.
Key exclusion criteria (12 listed)
- History of substance abuse or chronic opioid use.
- Known allergies to acetaminophen, oxycodone, or suzetrigine.
- Severe renal or hepatic dysfunction
- Estimated glomerular filtration rate less than 15 ml/min/1.73m^2
- History of kidney transplant
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 |
|---|---|---|
| suzetrigine 100mgParticipants will receive the recommended dosing for suzetrigine, which consists of a 100 mg oral loading dose taken in the recovery room prior to discharge, followed by 50 mg doses taken orally every 12 hours for 5 days, totaling 11 doses. | Drug | Participants undergoing thumb Basal Joint Replacement Surgery |
| AcetaminophenAs part of the multimodal pain regimen, participants will also receive acetaminophen (Tylenol) (500 mg, every 4 hours, or 1000 mg, every 8 hours) | Drug | Participants undergoing thumb Basal Joint Replacement Surgery |
Primary outcome
Postoperative pain
Time frame: 5 days
Participants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals
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 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Camilo Restrepo, MD study director
Rothman Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Basal Joint Osteoarthritis and Postoperative Pain, run by Rothman Institute Orthopaedics 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 12 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 23 Jul 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.
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?
Postoperative pain (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.