Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05858086
Status
Recruiting
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Conditions

  • Physical Therapy
  • Same-day Discharge
  • Total Joint Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Novel same-day discharge protocol after total joint arthroplasty — OTHER
    Preoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty
  • Conventional postoperative physical therapy clearance — OTHER
    Physical therapy evaluation and clearance after total joint arthroplasty

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Conventional Postoperative Physical Therapy Clearance
    Patients will be evaluated and cleared by physical therapy after total joint replacement surgery prior to home discharge
  • Experimental: Preoperative Physical Therapy, Postoperative Ambulation with Nursing
    Patients will receive gait/stair training from physical therapy prior to total joint arthroplasty, then ambulate with nursing postoperatively prior to home discharge

Primary Outcome Measure

Number of postoperative falls per patient [ Time Frame: 6 weeks postoperatively ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201
Sumon Nandi
[email protected]
617-717-8065
Hospital for Special SurgeryNew YorkNew York10021
Matthew Austin

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By research site
University of Maryland· Baltimore, MDHospital for Special Surgery· New York, NY

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