[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03261544":3,"trial-entities:NCT03261544":85,"trial-summary:NCT03261544":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":57,"locations":61,"central_contacts":74,"overall_officials":79,"references":83,"see_also_links":84},"NCT03261544","Pro00082717","Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?","RECRUITING","2028-11","2026-07","2026-07-15","2017-11-10","Duke University","OTHER",false,"The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.","Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.",[18,19,20],"Sarcoma","Bone Metastases","Proximal Femur Replacement",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},50,"ESTIMATED",[29],{"type":30,"name":20,"description":31,"armGroupLabels":32},"PROCEDURE","The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.",[20],[34,38,41],{"measure":35,"description":36,"timeFrame":37},"The Musculoskeletal Tumor Society (MSTS) score","The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.","up to 24 months postoperatively",{"measure":39,"description":40,"timeFrame":37},"Harris Hip Score","The Harris Hip Score (HHS) is a clinician-based outcome measure that is frequently used for the evaluation of patients following a Total Hip Arthroplasty (THA). The survey has ten questions and scores ranging from 0-100, with higher scores representing less dysfunction and better outcomes.",{"measure":42,"description":43,"timeFrame":37},"Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.","The adverse event form records the occurence of implant-related complications that occur during study participation.",[45],{"measure":46,"description":47,"timeFrame":37},"Gait Analysis as reported on the study's case report form","Motion data collected from gait analysis testing will be evaluated with OpenCap.","ALL","16 Years","75 Years",{"inclusion":52,"exclusion":53,"raw_text":56},[],[54,55],"Non-ambulatory before or after the procedure","Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up","Inclusion Criteria:\n\n• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon\n\nExclusion Criteria:\n\n* Non-ambulatory before or after the procedure\n* Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up",[58,59,60],"CHILD","ADULT","OLDER_ADULT",[62],{"facility":12,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":71},"Durham","North Carolina","27710","United States",[68],{"name":69,"role":70},"Elizabeth Sachs","CONTACT",{"lat":72,"lon":73},35.99403,-78.89862,[75],{"name":76,"role":70,"phone":77,"email":78},"Elizabeth Sachs, MS","9196609849","elizabeth.sachs@duke.edu",[80],{"name":81,"affiliation":12,"role":82},"William Eward, MD, DVM","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[87,20,18],"Metastatic Malignant Neoplasm in the Bone",[],{"nct_id":4,"found":90,"summary":91,"prompt_version":101},true,{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study aiming to enroll 50 participants. It will look back at existing patient records and also include new patients.","completed","Proximal Femur Replacement Study: Abductor Reattachment Methods","This observational study is looking at different ways to reattach abductor muscles during a Proximal Femur Replacement (a surgery where part of your thigh bone near the hip is replaced with an artificial one, often due to sarcoma or bone metastases). Researchers want to see if reattaching these muscles directly to the artificial bone leads to better hip function. They will measure this using scores like the Musculoskeletal Tumor Society (MSTS) score and the Harris Hip Score, and by tracking complications for up to 24 months after surgery. You may be able to join if you are between 16 and 75 years old, have had or are scheduled for this surgery, and are able to walk. The study is currently unclear on its recruitment status.","Participants will be followed for up to 24 months after their surgery to assess outcomes and complications.",125,"Not specified in the trial record.","Not stated in the trial record.",[20],"v2"]