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临床试验/NCT05900453
NCT05900453已完成不适用

Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 675 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
675
试验地点
1
主要终点
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)

研究概览

简要总结

This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.

详细描述

In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient underwent TKA for primary knee osteoarthritis
  • Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area

排除标准

  • Patients < 40 years old
  • Patients whose total episode of care length in outpatient physical therapy was < 21 days
  • Patients who attended < 3 outpatient physical therapy visits throughout their episode of care
  • Outcomes collected > 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery)
  • Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)

时间窗: KOOS-JR was assessed postoperatively up to 6 months after surgery

The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty (TKA). The KOOS-JR is scored on a 100-point scale with 0 representing complete knee disability and 100 representing perfect knee health. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness in the TKA population.

次要结局

  • Knee range of motion (ROM)(ROM was assessed postoperatively up to 6 months after surgery)
  • Outpatient Physical Therapy Visit Utilization(All visits from initial evaluation to discharge up to 1 year after surgery)
  • Time Up and Go (TUG)(TUG was assessed postoperatively up to 6 months after surgery)
  • Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.(Surveys were assessed postoperatively up to 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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