跳至主要内容
临床试验/NCT04087304
NCT04087304撤回不适用

Prospective Validation of a Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty

Rush University Medical Center2 个研究点 分布在 1 个国家开始时间: 2018年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Optimized Risk Factors

研究概览

简要总结

This study is a prospective validation study of a new hip and knee replacement-specific questionnaire that can be used to predict postoperative complications. The purpose of this study is to confirm the validity of a new hip and knee scoring system to be used as a clinical tool to predict potential complication rates in patients undergoing total hip or knee replacement surgery. This scoring system aims to stratify patients into specific risk categories based a standardized calculated score. Patients will be evaluated on health risk factors and severity of disease on radiographic imaging prior to surgery, associated to higher complication rates following surgery. The hopeful anticipated result of this study is a prospective validation of the scoring system with both statistical and clinical significance in predicting postoperative complication rates in patients with moderate to high health risk,

This stratification system may prove meaningful by allowing these patients, especially those classified as High-Risk, to be incorporated into more appropriate healthcare bundle payment systems that account for their higher financial demands. Furthermore, the stratification may allow for preoperative counseling and a shift towards non-operative management, or surgeon-patient conversations regarding the need to modify a portion of their objective risks prior to surgical intervention. Predictive risk models such as the one presented in the current study will be essential tools as the number of total hip arthroplasty procedures performed each year continue to increase and both the numbers of procedures and associated complications impose a significant cost on the U.S. healthcare system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must be male or female of any race.
  • Patients much be age greater than 18 years old.
  • Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.

排除标准

  • Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.
  • Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
  • Patients requiring use of revision THA or TKA components (stems, augments).
  • Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol

结局指标

主要结局

Optimized Risk Factors

时间窗: Optimization time period covers a total time period of 6 months.

A Scoring System Questionnaire with risk factors associated with increased risk of complications in patients undergoing total hip and knee arthroplasty will be collected Risk factors collected include obesity, drug allergies, presence of osteophytes, soft tissue to patella thickness, flexion contracture, diabetes, chronic opioid use, co-morbidities, prior knee surgeries, etiology of arthritis, smoking status, and reported disability. Each are measured on a scale of -5 to 10, with 10 being the best outcome. All the risk factors are added together and that comprises the total score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brett Levine, MD

Associate Professor

Rush University Medical Center

研究点 (2)

Loading locations...

相似试验