Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Novel same-day discharge protocol after total joint arthroplasty
Other interventionPreoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty
Conventional postoperative physical therapy clearance
Other interventionPhysical therapy evaluation and clearance after total joint arthroplasty
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Conventional Postoperative Physical Therapy ClearanceActive comparator 1 intervention
Group B: Preoperative Physical Therapy, Postoperative Ambulation with NursingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of postoperative falls per patient
Time frame
6 weeks postoperativelySecondary outcomes
1
Number of emergency room visits per patient
Time frame
90 days postoperatively2
Number of hospital readmissions per patient
Time frame
90 days postoperatively3
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.
Time frame
6 weeks postoperatively4
Patient reported outcome measure
Knee Injury and Osteoarthritis Outcome Score (KOOS, JR; range 0-100). Higher scores denote better outcome.
Time frame
6 weeks postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
West Virginia University
Sponsor institution
Hospital for Special Surgery, New York
Collaborator
Source ClinicalTrials.gov