NCT05858086

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Sep 2024Dec 2027

First Submitted

Initial submission to the registry

December 13, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

December 13, 2022

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of postoperative falls per patient

    6 weeks postoperatively

Secondary Outcomes (6)

  • Number of emergency room visits per patient

    90 days postoperatively

  • Number of hospital readmissions per patient

    90 days postoperatively

  • Patient satisfaction scores

    6 weeks postoperatively

  • Patient reported outcome measure

    6 weeks postoperatively

  • Patient reported outcome measure

    6 weeks postoperatively

  • +1 more secondary outcomes

Study Arms (2)

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

Other: Conventional postoperative physical therapy clearance

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

Other: Novel same-day discharge protocol after total joint arthroplasty

Interventions

Physical therapy evaluation and clearance after total joint arthroplasty

Conventional Postoperative Physical Therapy Clearance

Preoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty

Preoperative Physical Therapy, Postoperative Ambulation with Nursing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

NOT YET RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Chief of Adult Reconstruction, Director of Orthopaedic Research

Study Record Dates

First Submitted

December 13, 2022

First Posted

May 15, 2023

Study Start

September 27, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations