[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636293":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":32,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":10,"enrollmentInfo":43,"targetDuration":46,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":52,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":10},{"fullName":5,"class":6},"Restor3D","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Knee Cohort",null,"Adults who have received an FDA-cleared restor3d patient-specific knee implant (total knee replacement, unicompartmental knee replacement). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.",[13],"Device: Patient-Specific Orthopedic Implant",{"label":15,"type":10,"description":16,"interventionNames":17},"Hip Cohort","Adults who have received an FDA-cleared restor3d patient-specific hip implant. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Foot & Ankle Cohort","Adults who have received an FDA-cleared restor3d patient-specific ankle implant (total ankle replacement) or an FDA-approved restor3d patient-specific total talus replacement. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Shoulder Cohort","Adults who have received an FDA-cleared restor3d patient-specific shoulder implant (reverse total shoulder arthroplasty). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","Patient-Specific Orthopedic Implant","FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.",[19,15,9,23],{"type":33,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636293","the-restor3d-outcomes-registry-100636293",false,"NCT07563803","The restor3d Outcomes Registry","The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement","Master Protocol Inclusion Criteria:\n\n* Age ≥ 18 years\n* Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.\n\nMaster Protocol Exclusion Criteria:\n\n* Patient is receiving an implant not manufactured by restor3d\n* Patient is receiving a restor3d implant that is not FDA-cleared or approved\n* Patient lives outside the United States\n* Patient is receiving a restor3d implant that does not use a patient-specific plan, instrumentation or implant\n* Patient is non-English-speaking\n* Patient is receiving a restor3d implant outside of the defined implant cohorts\n* Patient does not provide informed consent\n* Plus additional cohort-specific exclusion criteria","ALL","18 Years",{"count":44,"type":45},2000,"ESTIMATED","5 Years","OBSERVATIONAL","The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant. Using a master protocol framework, the study enrolls patients across multiple joint cohorts (knee, hip, foot \\& ankle, shoulder) under a single protocol, with joint-specific details governed by individual appendices. Participants self-enroll and complete electronic PRO surveys (ePROs) before surgery and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively, all remotely, with no required in-person visits. The study aims to quantify changes in pain, function, quality of life, and satisfaction over time, and to establish real-world outcome benchmarks for patient-specific orthopedic implants.",[50,51],"Joint Replacement","Arthropathy",[53,54,55,56,57],"Knee arthroplasty","Hip arthroplasty","Ankle arthroplasty","Shoulder arthroplasty","restor3d","NOT_YET_RECRUITING","2026-04-30",{"date":61,"type":62},"2026-05-04","ACTUAL",{"date":64,"type":45},"2026-05-31",{"date":66,"type":45},"2032-05-31",{"name":5,"class":6}]