Total Joint ArthroplastyNCT05286515
A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty
A study testing Hybrid Peroperative PT and Standard Clinical Practice PT in people with Total Joint Arthroplasty, run by NYU Langone Health at 2 sites in United States.
Trial summary
This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Total Joint Arthroplasty
- What is being tested?
- Hybrid Peroperative PT and Standard Clinical Practice PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2022to 2 Jun 2023
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is above 55 years old, indicated for primary total knee or hip replacement surgery and is deconditioned based on the surgeon's clinical judgement (i.e., Use of walker, limited or staggered gait, difficulty in sit to stand) as recorded in study log.
- Patient falls below the median score on the HOOS/KOOS JR/PROMIS physical function (<47.4, <49.8, ≤ 37 respectively and below the median score on the PROMIS Pain Interference score (≥63).
- Patient has access to technology to participate in telehealth.
Who cannot join
- Patient is not ambulatory
- Patient is scheduled for bilateral arthroplasty or revision arthroplasty.
- Patient is morbidly obese (BMI >40).
- Patient has pre-existing medical condition that is contraindicated for exercise such as unstable cardiomyopathy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)
New York, New York, 10014
NYU Langone Orthopedic Center
New York, New York, 10016
About this study
This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.
Read the detailed description
Study objectives include: 1) testing the feasibility of a hybrid preoperative physical therapy intervention for physically deconditioned patients undergoing total hip and knee replacement, and 2) observing differences in post-surgical outcomes such as pain, pain interference, function and healthcare utilization, between patients who receive the intervention and those who do not.
- Conditions
- Total Joint Arthroplasty
- Being tested
- Hybrid Peroperative PT, Standard Clinical Practice PT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Peroperative PTOther
The intervention will consist of an in-person evaluation assessing the subject's functional level, lower and upper extremities range of motion, strength and endurance. The remaining sessions will be conducted via telehealth. The program will consist of two sessions per week up to six weeks. The program will start approximately 8 to 7 weeks before the scheduled surgery date.
Standard Clinical Practice PTOther
This group will follow the protocols established by the PT facility they chose. They will finish treatment two to three weeks before the surgery date, similar to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Preoperative Physical Therapy (PT) | Experimental | Not described Receives: Other: Hybrid Peroperative PT |
| Control Standard Physical Therapy (PT) | Active comparator | Not described Receives: Other: Standard Clinical Practice PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).
Measured: Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).
Measured: Month 2, Month 5
Secondary outcomes (11)
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Measured: Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Measured: Month 2, Month 5
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
PROMIS-PF-10 consists of 10 items. Item-levels are scored numerically for an individual's response to each question. The total score range is 10-100; higher scores mean more of a concept being measured (e.g., more fatigue).
Measured: Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
PROMIS-PF-10 consists of 10 items. Item-levels are scored numerically for an individual's response to each question. The total score range is 10-100; higher scores mean more of a concept being measured (e.g., more fatigue).
Measured: Month 2, Month 5
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
HOOS, JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.
Measured: Baseline, Month 2
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
HOOS, JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.
Measured: Month 2, Month 5
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Measured: Baseline, Month 2
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Measured: Month 2, Month 5
Average Number of Physical Therapy Sessions Since Enrollment in the Study
Self-reported
Measured: Month 2
Average Number of Times Per Week Participants Had Physical Therapy
Self-reported
Measured: Month 2
Number of Readmissions
Self-reported hospital readmission for any reason including revision surgery ED visits
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start29 Mar 2022
- Primary completion18 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Campello, PT, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286515
- Sponsor's protocol ID
- 21-01331
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT05286515
- Acronym / sponsor ID
- 21-01331
- Conditions
- Total Joint Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 18 Mar 2022 (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.
This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.
Detailed description
Study objectives include: 1) testing the feasibility of a hybrid preoperative physical therapy intervention for physically deconditioned patients undergoing total hip and knee replacement, and 2) observing differences in post-surgical outcomes such as pain, pain interference, function and healthcare utilization, between patients who receive the intervention and those who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Preoperative Physical Therapy (PT) | Experimental | Other: Hybrid Peroperative PT |
| Control Standard Physical Therapy (PT) | Active comparator | Other: Standard Clinical Practice PT |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is above 55 years old, indicated for primary total knee or hip replacement surgery and is deconditioned based on the surgeon's clinical judgement (i.e., Use of walker, limited or staggered gait, difficulty in sit to stand) as recorded in study log.
- Patient falls below the median score on the HOOS/KOOS JR/PROMIS physical function (<47.4, <49.8, ≤ 37 respectively and below the median score on the PROMIS Pain Interference score (≥63).
- Patient has access to technology to participate in telehealth.
Key exclusion criteria (4 listed)
- Patient is not ambulatory
- Patient is scheduled for bilateral arthroplasty or revision arthroplasty.
- Patient is morbidly obese (BMI >40).
- Patient has pre-existing medical condition that is contraindicated for exercise such as unstable cardiomyopathy
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 |
|---|---|---|
| Hybrid Peroperative PTThe intervention will consist of an in-person evaluation assessing the subject's functional level, lower and upper extremities range of motion, strength and endurance. The remaining sessions will be conducted via telehealth. The program will consist of two sessions per week up to six weeks. The program will start approximately 8 to 7 weeks before the scheduled surgery date. | Other | Hybrid Preoperative Physical Therapy (PT) |
| Standard Clinical Practice PTThis group will follow the protocols established by the PT facility they chose. They will finish treatment two to three weeks before the surgery date, similar to the intervention group. | Other | Control Standard Physical Therapy (PT) |
Primary outcome
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
Time frame: Baseline, Month 2
PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
Time frame: Month 2, Month 5
PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).
11 secondary outcomes
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
Time frame: Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
Time frame: Month 2, Month 5
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
Time frame: Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
Time frame: Month 2, Month 5
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Time frame: Baseline, Month 2
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Time frame: Month 2, Month 5
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
Time frame: Baseline, Month 2
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
Time frame: Month 2, Month 5
Average Number of Physical Therapy Sessions Since Enrollment in the Study
Time frame: Month 2
Average Number of Times Per Week Participants Had Physical Therapy
Time frame: Month 2
Number of Readmissions
Time frame: Month 5
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 18 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Marco Campello, PT, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Peroperative PT and Standard Clinical Practice PT in people with Total Joint Arthroplasty, run by NYU Langone Health 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: finished, as of the sponsor's last update on 18 Jul 2023. 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?
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?
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b (time frame: Baseline, Month 2). The study lists 2 primary outcomes in all. 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 18 Jul 2023.