NCT05858086 Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?
| NCT ID | NCT05858086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Physical Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2024-09-27 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT05858086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Physical Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05858086 currently recruiting?
Yes, NCT05858086 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Maryland, Baltimore to inquire about joining.
Where is the NCT05858086 trial being conducted?
This trial is being conducted at Baltimore, United States, New York, United States.
Who is sponsoring the NCT05858086 clinical trial?
NCT05858086 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 210 participants.