[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stryker Trauma and Extremities\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100602053","a-prospective-post-market-clinical-follow-up-study-of-the-incompass-total-ankle-system-100602053",false,"NCT07118501","A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System","Inclusion Criteria:\n\n1. The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC)\n2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;\n3. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.\n4. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.\n5. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).\n\nExclusion Criteria:\n\n1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;\n2. Participant is currently enrolled in or plans to enroll in any concurrent drug and\u002For device clinical investigation that, in the opinion of the Investigator, may confound results;\n3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.\n4. Participants who have participated previously in this clinical trial and who have been withdrawn.\n5. Participant who is, or will be, inaccessible for follow-up\n6. Participant is pregnant or intends to become pregnant during the course of the study.\n7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.\n8. Participants requiring revision total ankle replacement of the ankle being considered for the study;\n9. Participants with a failed previous ankle surgery (e.g., takedown fusion)\n10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;\n11. Participants with compromised vascularity that would inhibit blood supply to the operative site;\n12. Neuropathic arthropathy of the joint;\n13. Insufficient bone stock or bone quality that cannot provide adequate support of the device;\n14. Participants who have documented or suspected sensitivity to the implant materials.\n15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable\n16. Participant who routinely place excessive loads on their ankle as caused by activity and\u002For patient weight, per investigator discretion; or\n17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.","ALL","21 Years",{"count":18,"type":19},200,"ESTIMATED","OBSERVATIONAL","The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed.\n\nThe Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.",[23,24,25,26],"Post Traumatic Arthritis","Osteoarthritis","Total Ankle Replacement","Total Ankle Prosthesis",[25],"RECRUITING","2026-03-20",{"date":31,"type":32},"2026-03-24","ACTUAL",{"date":34,"type":32},"2026-02-06",{"date":36,"type":19},"2038-09-01",{"name":38,"class":39},"Stryker Trauma and Extremities","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100444447","perform-humeral-system-study-100444447","NCT05067543","Perform Humeral System Study","PHS","Inclusion Criteria:\n\n* 18 years or older at the time of the informed consent or non-opposition (when applicable).\n* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).\n* Willing and able to comply with the requirements of the study protocol.\n* Considered a candidate for shoulder arthroplasty using a study device.\n* Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements\n\nExclusion Criteria:\n\n* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)\n* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as \"vulnerable subject\" in the section 3.44 of the ISO 14155 norm).\n* Active local or systemic infection, sepsis, or osteomyelitis\n* Poor bone quality, where there could be considerable migration of the prothesis and\u002For a chance of fracture of the humerus or glenoid\n* Significant injury to the brachial plexus\n* Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components\n* Neuromuscular disease (e.g., joint neuropathy)\n* Patient with known allergy to one of the product materials\n* Metabolic disorders which may impair bone formation\n* Patient pregnancy\n* Planned for two-stage surgery","18 Years",{"count":50,"type":19},300,"This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.\n\nData collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and\u002For product development.",[53,54,55,56],"Osteoarthritis Shoulder","Avascular Necrosis","Post-traumatic Arthrosis of Other Joints, Shoulder Region","Rotator Cuff Tear Arthropathy","2026-02-19",{"date":59,"type":32},"2026-02-20",{"date":61,"type":32},"2021-09-12",{"date":63,"type":19},"2036-12-01",{"name":38,"class":39},10,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":40},"100373039","hand--wrist-pyrocarbon-implants-outcomes-clinical-study-100373039","NCT04137237","Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study","HaWPYC","Inclusion Criteria:\n\n* 18 years or older at the time he\u002Fshe receives the information and signs the informed consent (when applicable as per local regulatory requirements),\n* Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee,\n* Willing and able to comply with the requirements of the study protocol,\n* For prospective inclusion: considered for treatment with one of PyC Hand\u002FWrist study implants (primary or revision surgery),\n* For \"ambispective\" inclusion: must have undergone a Hand or Wrist arthroplasty with a PyC Hand\u002FWrist study implant before the date of first site initiation visit,\n\n  * Follow-up visits (at least the last two) must be prospective,\n  * Patient must have complete information available for each completed visit\n\nExclusion Criteria:\n\n* Patient pertaining to one of the categories referred to as \"vulnerable population\" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as \"particularly vulnerable persons\" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA),\n* Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times),\n* Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)",{"count":74,"type":19},417,"HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.",[77],"Orthopedics",[79,80,81],"Hand","Wrist","Surgery","2025-09-09",{"date":84,"type":32},"2025-09-16",{"date":86,"type":32},"2019-11-14",{"date":88,"type":19},"2033-01",{"name":38,"class":39},""]