PTClearSHoT: Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05858086

Collaborator

Rothman Institute Orthopaedics (Other)

210

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Therapy Total Joint Arthroplasty Same-day Discharge	Other: Novel same-day discharge protocol after total joint arthroplasty Other: Conventional postoperative physical therapy clearance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Conventional postoperative physical therapy clearance Physical therapy evaluation and clearance after total joint arthroplasty
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	Other: 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

Arm

Intervention/Treatment

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

Other: Conventional postoperative physical therapy clearance

Physical therapy evaluation and clearance after total joint arthroplasty

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

Other: 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

Outcome Measures

Primary Outcome Measures

Number of postoperative falls per patient [6 weeks postoperatively]

Secondary Outcome Measures

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]
Surgical Satisfaction Questionnaire-8 (SSQ-8; range 0-100) and numeric satisfaction scale (NSS; range 0-100). Higher scores denote better outcome.
Patient reported outcome measure [6 weeks postoperatively]
Knee Injury and Osteoarthritis Outcome Score (KOOS, JR; range 0-100). Higher scores denote better outcome.
Patient reported outcome measure [6 weeks postoperatively]
Hip Disability and Osteoarthritis Outcome Score (HOOS, JR; range 0-100). Higher scores denote better outcome.
Patient reported outcome measure [6 weeks postoperatively]
Patient-Reported Outcomes Measurement Information System (PROMIS; mean score 50 with standard deviation of 10). Higher scores denote more of measured domain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Maryland, Baltimore
Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sumon Nandi, Associate Professor, Chief of Adult Reconstruction, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT05858086

Other Study ID Numbers:

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 15, 2023