Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Musculoskeletal Tumor Society (MSTS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon
排除标准
- •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
结局指标
主要结局
The Musculoskeletal Tumor Society (MSTS) score
时间窗: up to 24 months postoperatively
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Harris Hip Score
时间窗: up to 24 months postoperatively
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.
Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.
时间窗: up to 24 months postoperatively
The adverse event form records the occurence of implant-related complications that occur during study participation.
次要结局
- Gait Analysis as reported on the study's case report form(up to 24 months postoperatively)