- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858086
Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary? (PTClearSHoT)
Is Postoperative Physical Therapy Clearance Necessary for Safe Home Discharge After Total Joint Arthroplasty?
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland
-
Contact:
- Sumon Nandi
- Phone Number: 617-717-8065
- Email: sumon.nandi@gmail.com
-
-
New York
-
New York, New York, United States, 10021
- Not yet recruiting
- Hospital for Special Surgery
-
Contact:
- Matthew Austin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
Preoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of postoperative falls per patient
Time Frame: 6 weeks postoperatively
|
6 weeks postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of emergency room visits per patient
Time Frame: 90 days postoperatively
|
90 days postoperatively
|
|
|
Number of hospital readmissions per patient
Time Frame: 90 days postoperatively
|
90 days postoperatively
|
|
|
Patient satisfaction scores
Time Frame: 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.
|
6 weeks postoperatively
|
|
Patient reported outcome measure
Time Frame: 6 weeks postoperatively
|
Knee Injury and Osteoarthritis Outcome Score (KOOS, JR; range 0-100).
Higher scores denote better outcome.
|
6 weeks postoperatively
|
|
Patient reported outcome measure
Time Frame: 6 weeks postoperatively
|
Hip Disability and Osteoarthritis Outcome Score (HOOS, JR; range 0-100).
Higher scores denote better outcome.
|
6 weeks postoperatively
|
|
Patient reported outcome measure
Time Frame: 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.
|
6 weeks postoperatively
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12 (Israel lung Association)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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