OsteoarthritisPT on POD 0NCT02879188
Ambulation Versus Standing on Postoperative Day 0
A study testing Physical Therapy and Standing in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Physical Therapy and Standing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- scheduled for primary TKA (Total Knee Arthroplasty) for any degenerative condition
- Anesthesia for TKA is Spinal + Regional block (Adductor Canal Block)
Who cannot join
- require assistive devices (walker, wheelchair) for ambulation preoperatively
- planning to go to a subacute nursing facility or acute rehab facility following surgery
- < 18 yrs of age
- not willing to participate or unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Ambulation Versus Standing on Postoperative Day 0: A Randomized, Controlled Trial
The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement.
- Conditions
- Osteoarthritis
- Being tested
- Physical Therapy, Standing
- Keywords
- degenerative joint disease, total knee arthroplasty, physical therapy, arthroplasty, replacement, knee
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Patients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist.
StandingOther
Patients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing.
| Study group | Role | What they receive |
|---|---|---|
| Ambulation | Experimental | Patients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist. Receives: Other: Physical Therapy |
| Standing | Active comparator | Patients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing. Receives: Other: Standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization Stay
The length of time patients stay in the hospital will be recorded and compared between groups.
Measured: 5 days
Secondary outcomes (1)
Patient Satisfaction
Patients will be prospectively surveyed at discharge and asked questions about their satisfaction with their care during their hospitalization.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
- Investigators
- Craig Della Valle, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879188
- Sponsor's protocol ID
- 1234568
- Acronym
- PT on POD 0
- Status last verified
- Mar 2019
- First submitted
- 22 Aug 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulation Versus Standing on Postoperative Day 0: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02879188
- Acronym / sponsor ID
- PT on POD 0 / 1234568
- Conditions
- Osteoarthritis
- Keywords
- degenerative joint disease, total knee arthroplasty, physical therapy, arthroplasty, replacement, knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulation | Experimental | Other: Physical TherapyPatients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist. |
| Standing | Active comparator | Other: StandingPatients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- scheduled for primary TKA (Total Knee Arthroplasty) for any degenerative condition
- Anesthesia for TKA is Spinal + Regional block (Adductor Canal Block)
Key exclusion criteria (4 listed)
- require assistive devices (walker, wheelchair) for ambulation preoperatively
- planning to go to a subacute nursing facility or acute rehab facility following surgery
- < 18 yrs of age
- not willing to participate or unable to consent
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 |
|---|---|---|
| Physical TherapyPatients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist. | Other | Ambulation |
| StandingPatients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing. | Other | Standing |
Primary outcome
Length of Hospitalization Stay
Time frame: 5 days
The length of time patients stay in the hospital will be recorded and compared between groups.
1 secondary outcome
Patient Satisfaction
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Craig Della Valle, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Standing in people with Osteoarthritis, run by Rush University Medical Center at 1 site 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: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospitalization Stay (time frame: 5 days). 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 28 Mar 2019.