Physical TherapyPTClearSHoTNCT05858086
Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?
A study testing Novel same-day discharge protocol after total joint arthroplasty and Conventional postoperative physical therapy clearance in people with Physical Therapy and Total Joint Arthroplasty, run by University of Maryland, Baltimore at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Physical Therapy, Total Joint Arthroplasty, Same-day Discharge
- What is being tested?
- Novel same-day discharge protocol after total joint arthroplasty and Conventional postoperative physical therapy clearance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Sumon Nandi, 617-717-8065, sumon.nandi@gmail.com
- Not yet recruiting
Hospital for Special Surgery
New York, New York, 10021
Matthew Austin
About this study
Official title: 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.
- Being tested
- Novel same-day discharge protocol after total joint arthroplasty, Conventional postoperative physical therapy clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel same-day discharge protocol after total joint arthroplastyOther
Preoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty
Conventional postoperative physical therapy clearanceOther
Physical therapy evaluation and clearance after total joint arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Conventional Postoperative Physical Therapy Clearance | Active comparator | Patients will be evaluated and cleared by physical therapy after total joint replacement surgery prior to home discharge Receives: Other: Conventional postoperative physical therapy clearance |
| Preoperative Physical Therapy, Postoperative Ambulation with Nursing | Experimental | Patients will receive gait/stair training from physical therapy prior to total joint arthroplasty, then ambulate with nursing postoperatively prior to home discharge Receives: Other: Novel same-day discharge protocol after total joint arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative falls per patient
Measured: 6 weeks postoperatively
Secondary outcomes (6)
Number of emergency room visits per patient
Measured: 90 days postoperatively
Number of hospital readmissions per patient
Measured: 90 days postoperatively
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.
Measured: 6 weeks postoperatively
Patient reported outcome measure
Knee Injury and Osteoarthritis Outcome Score (KOOS, JR; range 0-100). Higher scores denote better outcome.
Measured: 6 weeks postoperatively
Patient reported outcome measure
Hip Disability and Osteoarthritis Outcome Score (HOOS, JR; range 0-100). Higher scores denote better outcome.
Measured: 6 weeks postoperatively
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.
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start27 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Principal investigator, Sumon Nandi, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858086
- Sponsor's protocol ID
- 12
- Acronym
- PTClearSHoT
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Postoperative Physical Therapy Clearance Necessary for Safe Home Discharge After Total Joint Arthroplasty?
- ClinicalTrials.gov ID
- NCT05858086
- Acronym / sponsor ID
- PTClearSHoT / 12
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Postoperative Physical Therapy Clearance | Active comparator | Other: Conventional postoperative physical therapy clearancePatients will be evaluated and cleared by physical therapy after total joint replacement surgery prior to home discharge |
| Preoperative Physical Therapy, Postoperative Ambulation with Nursing | Experimental | Other: Novel same-day discharge protocol after total joint arthroplastyPatients will receive gait/stair training from physical therapy prior to total joint arthroplasty, then ambulate with nursing postoperatively prior to home discharge |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel same-day discharge protocol after total joint arthroplastyPreoperative gait/stair training with physical therapy, then postoperative ambulation with nursing after total joint arthroplasty | Other | Preoperative Physical Therapy, Postoperative Ambulation with Nursing |
| Conventional postoperative physical therapy clearancePhysical therapy evaluation and clearance after total joint arthroplasty | Other | Conventional Postoperative Physical Therapy Clearance |
Primary outcome
Number of postoperative falls per patient
Time frame: 6 weeks postoperatively
6 secondary outcomes
Number of emergency room visits per patient
Time frame: 90 days postoperatively
Number of hospital readmissions per patient
Time frame: 90 days postoperatively
Patient satisfaction scores
Time frame: 6 weeks postoperatively
Patient reported outcome measure
Time frame: 6 weeks postoperatively
Patient reported outcome measure
Time frame: 6 weeks postoperatively
Patient reported outcome measure
Time frame: 6 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel same-day discharge protocol after total joint arthroplasty and Conventional postoperative physical therapy clearance in people with Physical Therapy and Total Joint Arthroplasty, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of postoperative falls per patient (time frame: 6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.