Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

NCT ID: NCT05858086

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2025-12-31

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.

Conditions

Physical Therapy; Total Joint Arthroplasty; Same-day Discharge

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Conventional Postoperative Physical Therapy Clearance

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

Group Type: ACTIVE_COMPARATOR

Conventional postoperative physical therapy clearance

Intervention Type: OTHER

Physical therapy evaluation and clearance after total joint arthroplasty

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

Group Type: EXPERIMENTAL

Novel same-day discharge protocol after total joint arthroplasty

Intervention Type: OTHER

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

Interventions

Novel same-day discharge protocol after total joint arthroplasty

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

Intervention Type: OTHER

Conventional postoperative physical therapy clearance

Physical therapy evaluation and clearance after total joint arthroplasty

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Sumon Nandi

Associate Professor, Chief of Adult Reconstruction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland

Baltimore, Maryland, United States

Site Status: RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Facility Contacts

Sumon Nandi

Role: primary

sumon.nandi@som.umaryland.edu

617-717-8065

Matthew Austin

Role: primary

Other Identifiers

12

Identifier Type: -

Identifier Source: org_study_id