[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654044":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":63,"studyPopulation":56,"armGroups":64,"interventions":71,"overallOfficials":56,"centralContacts":79,"locations":56,"responsibleParty":85,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":56,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":120,"whyStopped":56,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":56},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative Postoperative Opioid Consumption Through Postoperative Day 14","Cumulative opioid consumption will be calculated as the total amount of opioid medication used from postoperative day 0 through postoperative day 14 and converted to morphine milligram equivalents (MME). Higher MME values indicate greater opioid consumption.","Postoperative day (POD) 0 through Postoperative Day 14",[14,18,21,24,27,30,33,37,40,44,48,52],{"measure":15,"description":16,"timeFrame":17},"Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS)","Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher NPRS scores indicate greater pain intensity.","24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery",{"measure":19,"description":20,"timeFrame":17},"Pain Interference Assessed by PROMIS Pain Interference 6b","Pain interference will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Pain Interference 6b (PROMIS Pain Interference 6b). The instrument contains 6 items assessing the extent to which pain interferes with activities and aspects of daily life. Raw scores range from 6 to 30 and are converted to standardized T-scores ranging from 41.0 to 78.3. Higher scores indicate greater pain interference and a worse outcome.",{"measure":22,"description":23,"timeFrame":17},"Pain Intensity Assessed by PROMIS Pain Intensity 3a","Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System Scale v1.0 - Pain Intensity 3a (PROMIS Pain Intensity 3a). The instrument contains 3 items assessing worst pain, average pain, and current pain. Raw scores range from 3 to 15 and are converted to standardized T-scores ranging from 36.3 to 81.8. Higher scores indicate greater pain intensity and a worse outcome.",{"measure":25,"description":26,"timeFrame":17},"Physical Function Assessed by PROMIS Physical Function 10a","Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 10a (PROMIS Physical Function 10a). The instrument contains 10 items assessing the ability to perform physical activities and activities of daily living. Raw scores range from 10 to 50 and are converted to standardized T-scores ranging from 13.5 to 61.9. Higher scores indicate better physical function and a better outcome.",{"measure":28,"description":29,"timeFrame":17},"Pain Intensity Assessed by the Visual Analog Scale","Pain intensity will be assessed using the Visual Analog Scale (VAS). Possible scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity and a worse outcome.",{"measure":31,"description":32,"timeFrame":17},"Patient Satisfaction With Postoperative Pain Management","Patient satisfaction with postoperative pain management will be assessed using a 6-point Likert scale. Possible scores range from 0 to 5, with higher scores indicating greater satisfaction and a better outcome. Participants will also be asked an open-ended question regarding their experience with suzetrigine; the open-ended response is qualitative and is not included in the numerical satisfaction score.",{"measure":34,"description":35,"timeFrame":36},"Number of Participants With Adverse Events","The number and proportion of participants experiencing one or more adverse events will be recorded. Patient-reported adverse events will be collected using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and clinician-reported adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE).","2 weeks, 1 month, 3 months, 6 months after surgery",{"measure":38,"description":39,"timeFrame":36},"Severity of Adverse Events","Severity of clinician-reported adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), and patient-reported symptomatic adverse events will be assessed using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Higher grades or response levels indicate greater adverse-event severity and a worse outcome. PRO-CTCAE consists of individual symptom items and does not produce a single overall composite score.",{"measure":41,"description":42,"timeFrame":43},"Proportion of Participants Opioid-Free by Postoperative Day 14","The proportion of participants who are opioid-free by postoperative day 14 will be determined from recorded postoperative opioid use. Results will be reported as the percentage of participants who are opioid-free at postoperative day 14.","Postoperative day 14",{"measure":45,"description":46,"timeFrame":47},"Proportion of Participants Requiring Rescue Analgesia","The proportion of participants requiring at least one rescue analgesic because of inadequate pain control will be recorded. Rescue analgesics include medications administered as needed when routine postoperative pain management is insufficient. A higher proportion indicates greater need for additional analgesia.","Postoperative day 0 through postoperative day 14",{"measure":49,"description":50,"timeFrame":51},"Baseline Risk for Opioid Use Disorder Assessed by the Opioid Risk Tool for Opioid Use Disorder","Baseline risk for opioid use disorder will be assessed using the Opioid Risk Tool for Opioid Use Disorder (ORT-OUD), a 9-item self-report screening instrument. Total scores range from a minimum of 0 to a maximum of 9. Scores of 0-2 indicate lower risk and scores of 3-9 indicate higher risk for future opioid use disorder. Higher scores indicate greater risk and therefore a worse outcome.","Preoperative baseline",{"measure":53,"description":54,"timeFrame":55},"Opioid Misuse Behaviors Assessed by the Current Opioid Misuse Measure","Postoperative opioid misuse behaviors will be assessed using the Current Opioid Misuse Measure (COMM), a 17-item self-report instrument. Each item is scored from 0 to 4, producing a total score ranging from a minimum of 0 to a maximum of 68. Higher scores indicate greater evidence of current opioid misuse behaviors and a worse outcome.","Routine postoperative follow-up visits through 6 months after surgery at 2 weeks, 1 month, 3 months, 6 months",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"NA","SINGLE_GROUP","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE","Total ankle arthroplasty (TAA) causes substantial acute postoperative pain, typically managed with multimodal analgesia including acetaminophen, NSAIDs, and as-needed opioids. Reducing early postoperative opioid exposure is a recognized priority.\n\nSuzetrigine is a selective NaV1.8 sodium channel inhibitor acting on peripheral pain-sensing neurons. This single-arm, open-label prospective cohort study enrolls patients undergoing primary TAA who will receive suzetrigine in addition to standard multimodal analgesia. Outcomes are compared with a historical control group of patients who underwent primary TAA at the same institution during the preceding five years and received standard multimodal analgesia alone, identified retrospectively.",[65],{"label":66,"type":67,"description":68,"interventionNames":69},"Group","EXPERIMENTAL","Participants undergoing primary total ankle arthroplasty receive oral suzetrigine in addition to the institution's standard multimodal analgesic regimen.",[70],"Drug: Suzetrigine",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","Suzetrigine","Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.",[66],[78],"Journavx",[80],{"name":81,"role":82,"phone":83,"phoneExt":56,"email":84},"Mani Eftekhari, BS","CONTACT","5108506056","meftekhari@mgh.harvard.edu",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"SPONSOR_INVESTIGATOR","Soheil Ashkani Esfahani","Director of Foot & Ankle Research and Innovation Lab (FARIL)",[90],{"name":91,"class":92},"Vertex Pharmaceuticals Incorporated","INDUSTRY","100654044","phase-4-suzetrigine-for-postoperative-pain-after-total-ankle-replacement-100654044",false,"NCT07795827","Suzetrigine for Postoperative Pain After Total Ankle Replacement","Project Suzetrigine: The Efficacy and Safety of Suzetrigine (Journavx™) Following Total Ankle Arthroplasty: an Exploratory Prospective Cohort Study","SUZY-TAA","Inclusion Criteria:\n\n* Adult patients aged 18-75 years\n* Undergoing primary total ankle arthroplasty (TAA)\n* Capable of completing study questionnaires\n* Capable of providing informed consent for enrollment\n* Capable of taking suzetrigine twice daily\n* Capable of completing the required follow-up visits\n\nExclusion Criteria:\n\n* Declines to participate or discontinues participation during the study\n* Body mass index (BMI) ≥50 kg\u002Fm²\n* Preoperative or current opioid use\n* Prior history of ipsilateral ankle infection\n* Severe hepatic impairment (Child-Pugh Class C)\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Pregnant or lactating\n* Heart failure or recent myocardial infarction\n* Requires non-antiplatelet anticoagulant therapy (e.g., heparin, warfarin \\[Coumadin\\], apixaban \\[Eliquis\\], or enoxaparin \\[Lovenox\\])\n* Use of strong cytochrome P450 3A (CYP3A) inhibitors (e.g., itraconazole) or strong or moderate CYP3A inducers (e.g., rifampin)\n* Women taking concomitant progestin-containing contraceptives other than levonorgestrel or norethindrone who are unwilling to use an additional non-hormonal contraceptive method (e.g., condoms) or an alternative contraceptive during suzetrigine treatment and for 28 days after discontinuation","ALL","18 Years","75 Years",{"count":105,"type":106},28,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","This study is testing whether adding a non-opioid pain medicine called suzetrigine (Journavx) to the usual combination of pain medicines helps people recover more comfortably after ankle replacement surgery.\n\nAdults aged 18 to 75 who are scheduled for a first-time total ankle replacement may join. Everyone who joins will receive suzetrigine in addition to their usual pain medicines. Study visits happen at the same times as normal follow-up appointments after surgery.\n\nAt these visits, participants will rate their pain, answer questionnaires about how pain affects daily life, mood, and physical activity, report how much pain medicine they have taken, report any side effects, and have their ankle motion measured.",[112,113,114],"Ankle Osteoarthritis","Postoperative Pain","Acute Pain",[116,117,118,119],"suzetrigine","total ankle arthroplasty","postoperative pain management","foot and ankle surgery","NOT_YET_RECRUITING","2026-09-29",{"date":123,"type":124},"2026-09-30","ACTUAL",{"date":126,"type":106},"2026-10-01",{"date":128,"type":106},"2028-04-01",{"name":87,"class":6}]