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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05858086
Other study ID # 12
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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