Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

Physical Therapy Clinical Trial

— PTClearSHoT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858086
• Other study ID #: 12
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Therapy
• Total Joint Arthroplasty

Intervention

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
• Conventional postoperative physical therapy clearance
Physical therapy evaluation and clearance after total joint arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Rothman Institute Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postoperative falls per patient		6 weeks postoperatively
Secondary	Number of emergency room visits per patient		90 days postoperatively
Secondary	Number of hospital readmissions per patient		90 days postoperatively
Secondary	Patient satisfaction scores	Surgical Satisfaction Questionnaire-8 (SSQ-8; range 0-100) and numeric satisfaction scale (NSS; range 0-100). Higher scores denote better outcome.	6 weeks postoperatively
Secondary	Patient reported outcome measure	Knee Injury and Osteoarthritis Outcome Score (KOOS, JR; range 0-100). Higher scores denote better outcome.	6 weeks postoperatively
Secondary	Patient reported outcome measure	Hip Disability and Osteoarthritis Outcome Score (HOOS, JR; range 0-100). Higher scores denote better outcome.	6 weeks postoperatively
Secondary	Patient reported outcome measure	Patient-Reported Outcomes Measurement Information System (PROMIS; mean score 50 with standard deviation of 10). Higher scores denote more of measured domain.	6 weeks postoperatively