跳至主要内容
临床试验/NCT05858086
NCT05858086招募中不适用

Is Postoperative Physical Therapy Clearance Necessary for Safe Home Discharge After Total Joint Arthroplasty?

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
2
主要终点
Number of postoperative falls per patient

研究概览

简要总结

Conventionally, physical therapy (PT) clearance is sought before total joint arthroplasty (TJA) discharge. However, PT staffing limitations may preclude same-day discharge in patients having surgery late in the day. Failed same-day discharge in eligible TJA patients results in unnecessary hospital bed occupancy, which increases costs, limits operating room throughput for patients requiring inpatient admission, and introduces risks associated with longer length-of-stay.

In collaboration with an institutional PT department, the investigators developed a protocol for discharging same-day TJA patients without postoperative PT clearance. Immediately preoperatively, PT administers gait training. Patients are then discharged home after ambulating with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization. This allows for the maximum number of patients discharged home, including the last patient of the day, PT staffing limitations notwithstanding. Single-institution pilot data demonstrates no increased risk of falls, emergency room (ER) visits, or readmissions with this process.

The investigators propose a prospective, controlled, multicenter study to expand on pilot data. The study aim is to assess safety of day-of-surgery preoperative PT and postoperative ambulation with PACU nursing before TJA discharge. The primary endpoint is postoperative falls, while secondary endpoints include 90-day ER visits, 90-day hospital readmissions, patient-reported outcome measures, and patient satisfaction scores.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •are 18 years of age or older
  • •undergo primary THA or TKA
  • •are eligible for same-day home discharge (friends or family available to stay at home with the patient for one week postoperatively and medically stable for discharge from PACU per anesthesia).

排除标准

  • •90 years of age or older
  • •have sleep apnea (not eligible for same-day discharge)
  • •require overnight stay for any reason
  • •undergo revision THA or TKA.

研究组 & 干预措施

Conventional Postoperative Physical Therapy Clearance

Active Comparator

Patients will be evaluated and cleared by physical therapy after total joint replacement surgery prior to home discharge

干预措施: Conventional postoperative physical therapy clearance (Other)

Preoperative Physical Therapy, Postoperative Ambulation with Nursing

Experimental

Patients will receive gait/stair training from physical therapy prior to total joint arthroplasty, then ambulate with nursing postoperatively prior to home discharge

干预措施: Novel same-day discharge protocol after total joint arthroplasty (Other)

结局指标

主要结局

Number of postoperative falls per patient

时间窗: 6 weeks postoperatively

次要结局

  • Number of emergency room visits per patient(90 days postoperatively)
  • Patient satisfaction scores(6 weeks postoperatively)
  • Number of hospital readmissions per patient(90 days postoperatively)
  • Patient reported outcome measure(6 weeks postoperatively)

研究者

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

Sumon Nandi

Clinical Professor, Chief of Adult Reconstruction, Director of Orthopaedic Research

West Virginia University

研究点 (2)

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