[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530920":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":39,"responsibleParty":58,"collaborators":27,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":27,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":27,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Traditional","ACTIVE_COMPARATOR","In the STANDARD group, patients will undergo a primary TAR by implanting a prosthetic model of a standard design, that is the same for all using the usual surgical technique and instrumentation (based on the use of external leg guidance)",[13],"Procedure: Total ankle arthroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Custom","EXPERIMENTAL","In the PERSONALIZED group, patients will undergo a primary TAR by implanting a prosthetic model with a design specifically based on each patient's actual ankle morphology and using PSI surgical technique and instrumentation.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Total ankle arthroplasty","Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.",[15,9],[26],"Total ankle arthroplasty with anterior approach",null,[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"massimiliano mosca, MD","CONTACT","0516366","162","massimiliano.mosca@ior.it",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},"silvio caravelli, MD","084","silvio.caravelli@ior.it",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Rizzoli Orthopaedic Institute","RECRUITING","Bologna","BO","40126","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.33875,44.49381,{"lat":52,"lon":51},[55],{"name":56,"role":31,"phone":57,"phoneExt":27,"email":34},"Massimiliano Mosca","0516366080",{"type":59,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100530920","comparison-of-customized-and-standard-total-ankle-prostheses-100530920",false,"NCT06193057","Comparison of Customized and Standard Total Ankle Prostheses","Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study","Inclusion Criteria:\n\n* Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.\n* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.\n* Patients who have signed the \"informed consent\" approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Social conditions (homeless patients, with restrictions on personal freedom)\n* ASA 3 and 4\n* Deep venous insufficiency Lower limbs\n* History of Erisipelas lower limbs\n* Neurological or psychocognitive disorders\n* neurological diseases\n* Axial deformities of ankle \\>15°\n* Personal or family history of DVT or EP\n* Prosthetic and\u002For arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)\n* Pregnant women\n* Patients with rheumatic diseases\n* Patients that requires ancillary surgical procedures","ALL","40 Years","75 Years",{"count":71,"type":72},24,"ESTIMATED","INTERVENTIONAL",[75],"NA","The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures",[78],"Ankle Osteoarthritis",[80,81,82,83,84,85],"replacement","customized","TAR","arthroplasty","radiographic angles","clinical scores","2025-12-22",{"date":88,"type":89},"2025-12-29","ACTUAL",{"date":91,"type":89},"2023-07-26",{"date":93,"type":72},"2027-04-26",{"name":5,"class":6},1]