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临床试验/NCT06821269
NCT06821269进行中(未招募)不适用

Functional Recovery After Total Knee Arthroplasty

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Timed Up and Go (TUG)

研究概览

简要总结

The goal of this observational study is to learn about patients' recoveries after receiving total knee arthroplasty (TKA). The main questions it aims to answer are:

Does robotic-assisted TKA have improved perceived recovery when compared to conventional TKA? Does robotic-assisted TKA lead to improved functional recovery when compared to conventional TKA?

Researchers will compare if robotic-assisted versus conventional procedures lead to different recovery speeds.

Participants will answer questionnaires and undergo physical therapy testing before and at several timepoints after their procedure.

详细描述

The choice to perform robotic assisted vs manual total knee arthroplasties (TKA) depends on many factors, including but not limited to surgeon training, resource availability, and patient-specific considerations. Recent studies comparing patient outcomes after robotic-assisted and manual total knee arthroplasties have shown mixed results. These studies often focus on future complication rates, radiographic outcomes, or patient reported outcomes between manual and robotic-assisted TKA. Hence, there has been little focus on improvements in functional outcomes after TKA. Combining functional test results, patient reported outcomes, kinematic studies, and data from wearable devices will allow for a comprehensive timeline of recovery speed after either robotic-assisted or manual TKA.

The overall aim of this proposed study is to quantify functional and PROM at specific timepoints in patients after robotic-assisted or manual total knee arthroplasty (TKA).

The questions are:

  1. Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?
  2. Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?
  3. Do robotic-assisted revision TKAs have similar functional and perceived recovery as robotic-assisted primary TKAs?

For questions 1 and 2, we hypothesize that robotic-assisted revision or primary TKAs will have improved recovery when compared to manual TKAs.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidate for TKA
  • Speak English / understand study instructions--this is necessary to reliably complete the study questionnaires and understand study instructions which are not validated in other languages
  • Have medical clearance from PCP, PI, or co-Investigator to participate in the study
  • Willing to comply with all study procedures and be available for the duration of the study

排除标准

  • 2+ falls in the past year
  • Unable to ambulate 100 ft without assistive device or rest period
  • Acute illness
  • Have a history of cardiovascular disease or hypertension not controlled by medication
  • Severe visual impairment
  • Lower-extremity amputation
  • Neurological, muscular, systemic, or connective tissue disorder affecting the function of the lower extremities
  • Terminal illness
  • Plans to have another joint replacement during study period
  • Plans to relocate from immediate area during study period

研究组 & 干预措施

Manual Revision TKA

These patients underwent revision TKA done manually

干预措施: Manual revision total knee arthroplasty (Procedure)

Robotic-assisted Revision TKA

These patients underwent revision TKA with robotic-assistance

干预措施: Robotic assisted revision total knee arthroplasty (Procedure)

Manual Primary TKA

These patients received primary TKAs done manually

干预措施: Manual total knee arthroplasty (Procedure)

Robotic-assisted Primary TKA

These patients received primary TKAs with robotic-assistance

干预措施: Robotic assisted total knee arthroplasty (Procedure)

结局指标

主要结局

Timed Up and Go (TUG)

时间窗: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

TUG requires the patient to sit in a chair, stand, walk to a line 3m away, turn, walk back to the chair, and sit again

2-minute Walk

时间窗: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

Y Balance Test

时间窗: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

The YBT requires the person to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial

4m and 10m Walking Speed Test

时间窗: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

Stair Climb Test

时间窗: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

次要结局

  • Forgotten Joint Score(anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery)
  • SF36(anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery)
  • KOOS(anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery)
  • Promis(anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery)

研究者

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

Kenneth Urish

Associate Professor

University of Pittsburgh

研究点 (1)

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