Total Knee ArthroplastyNCT05288803
Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories
An observational study of Total Knee Arthroplasty, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Clinical decision support tool (CDS tool)
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2022to 30 Jun 2027
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with total knee replacement who seek postoperative outpatient physical therapy treatment at the participating clinics
Who may be able to join
- -Veterans who have undergone total knee arthroplasty who present for outpatient rehabilitation treatment at the participating clinics within three weeks of surgery
Who cannot join
- postoperative rehabilitation treatment received in the home health or skilled nursing
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
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Jennifer E Stevens-Lapsley, PhD, (303) 949-9304, Jennifer.Stevens-Lapsley@va.gov
Amy L Peters, (720) 261-9774, Amy.Peters3@va.gov
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Brad Krushinski, (41-2) -3110, brad.krushinski@va.gov
Ann Reppermund, (412)5187648, ann.reppermund@va.gov
About this study
This study will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. The investigators clinical support decision tool is designed to help physical therapists tailor rehabilitation treatments and dosages to the individual needs, goals, and preferences of Veterans recovering from TKA. This study has the potential to improve Veterans' functional recovery after TKA, while simultaneously reducing the average number of physical therapy visits Veterans attend after surgery by tailoring rehabilitation dosage based upon need. This will ensure the Veterans Health Administration (VHA) has the resources and capacity to provide adequate rehabilitation to every Veteran seeking TKA in the VHA system. Additionally, if successful, this clinical decision support tool could be used to improve outcomes and access for additional patient populations in the future.
Read the detailed description
Rehabilitation after total knee arthroplasty (TKA) is typically generic and inefficient; most patients receive the same contents and dosage of rehabilitation regardless of the patients individual needs, preferences, or expectations. This generic treatment paradigm will be unsustainable in the Veterans Health Administration (VHA) as the demand for TKA surgery and postoperative care increase exponentially in the near future. Without new strategies to improve the efficiency of TKA rehabilitation, organizations like the VHA will struggle to meet and pay for this surging demand, and Veterans may be denied timely access to the postoperative care they need for optimal recovery. The investigators have developed an innovative new clinical decision support (CDS) tool to optimize efficiency in TKA rehabilitation. Using the actual recovery data of similar historical patients, the tool can predict the recovery trajectory for new patients after TKA. This allows clinicians to (1) allocate rehabilitation resources based upon individual need, (2) identify Veterans at risk for suboptimal outcomes early after surgery, (3) tailor treatment strategies to Veterans' unique goals and clinical presentation, and (4) monitor Veterans' recovery relative to expected throughout postoperative rehabilitation. In this project, the investigators propose to expand the CDS tool's capabilities by establishing utilization guidelines based upon individual Veteran's predicted recovery (Aim 1). These guidelines will be established by expert consensus in a three round Delphi process. Subsequently, the investigators will test the CDS tool's impact on Veteran's functional recovery and rehabilitation utilization in four VHA outpatient physical therapy clinics using a pre-post design (Aim 2). The investigators will compare patient-reported function (Knee Injury and Osteoarthritis Outcome Score, Joint Replacement) and physical therapy visit utilization between cohorts of Veterans treated with and without the CDS tool. Additionally, the investigators will gather data from participating VHA clinicians and Veterans regarding the translation of the investigators tool into clinical practice to assess its readiness for dissemination throughout the VHA (Aim 3). This will include qualitative data from participant focus groups and quantitative process data regarding the tool's utilization. Ultimately, the investigators expect this study will serve as a template for expanding the investigators tool's capabilities into numerous VHA populations in rehabilitation and beyond.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Clinical decision support tool (CDS tool)
- Keywords
- total knee arthroplasty, patient-centered care, precision medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support tool (CDS tool)Other
Also called Knee Recovery Tool
The investigators will integrate the CDS tool into clinical practice at each participating clinic after data collection for the Control cohort is complete. All physical therapists at the participating clinic locations will use the CDS tool to inform rehabilitation decision making for Veterans with total knee arthroplasty. The CDS tool will provide personalized information regarding each Veterans' recovery in addition to personalized visit utilization guidelines. Clinicians will use the CDS tool with Veterans at their initial postoperative visits and every 2weeks throughout their course of care thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | The investigators will collect outcomes for 100 Veterans treated with usual care rehabilitation after total knee arthroplasty. Data will be collected at all participating clinical locations. Data collection for these Veterans will precede data collection for the intervention cohort. | |
| Intervention cohort | The investigators will implement the clinical decision support tool in all participating clinic locations. We will collect outcomes for 100 Veterans treated in rehabilitation with use of the clinical decision support tool. Data collection for these Veterans will occur after data collection is complete for the Control cohort. Receives: Other: Clinical decision support tool (CDS tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome - Joint Replacement (KOOS, JR)
The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness. KOOS JR will be assessed preoperatively at baseline and re-assessed at 90 (primary timepoint) and 180 days after TKA surgery. KOOS JR will also be assessed postoperatively throughout participants' rehabilitation episode at approximately 2-week intervals up to 180 days after surgery. We will use the interval scoring method for the KOOS JR which ranges from 0 (total knee disability) to 100 (perfect knee health)
Measured: Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)
Outpatient Physical Therapy Visit Utilization
The total outpatient physical therapy visits used in the first 90 postoperative days by each Veteran participant will be extracted from the electronic health record after the Veteran is formally discharged from outpatient rehabilitation. Any visits that occur prior to a Veteran's surgery or in the hospital setting will not count toward the total visit number. We chose postoperative day 90 as our primary endpoint because it corresponds with the average discharge timeframe for outpatient rehabilitation after total knee arthroplasty. Visit utilization will also be assed at at 30, 60, and 180 days after TKA surgery.
Measured: Postoperative day 90
Secondary outcomes (4)
Lower Extremity Functional Scale (LEFS)
The LEFS is a generic scale of lower extremity physical function that has established validity, reliability, and sensitivity to change for patients with total knee arthroplasty. The LEFS scale ranges from 0 (lowest function) to 80 (highest function).
Measured: Collected preoperatively at baseline with follow up assessments at 90 and 180 days after TKA surgery
Timed Up and Go (TUG)
The TUG is a basic measure of mobility and balance which consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. The TUG is responsive to change with adequate reliability in the acute recovery period after total knee arthroplasty.
Measured: Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Knee range of motion (ROM)
Knee ROM will be measured manually by goniometry which is a valid and reliable technique for measuring knee mobility. Recovery of knee ROM after TKA is necessary for many functional activities and is emphasized in rehabilitation after total knee arthroplasty.
Measured: Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale
The WOMAC pain subscale is a valid, reliable, and responsive measure of patient-reported pain for individuals with osteoarthritis of the knee. The WOMAC pain subscale scores range from 0 (lowest pain) to 20 (highest pain).
Measured: Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens-Lapsley, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288803
- Sponsor's protocol ID
- F3770-R
- Other IDs
- 5I01RX003770-04, I01RX003770
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. All data released will be de-identified, with no information that could be linked to any study participants (patients and clinicians), or participating study practices to ensure the confidentiality of all participants and practices. If necessary, a data use agreement will be established.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories
- ClinicalTrials.gov ID
- NCT05288803
- Acronym / sponsor ID
- F3770-R
- Conditions
- Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, patient-centered care, precision medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 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 will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. The investigators clinical support decision tool is designed to help physical therapists tailor rehabilitation treatments and dosages to the individual needs, goals, and preferences of Veterans recovering from TKA. This study has the potential to improve Veterans' functional recovery after TKA, while simultaneously reducing the average number of physical therapy visits Veterans attend after surgery by tailoring rehabilitation dosage based upon need. This will ensure the Veterans Health Administration (VHA) has the resources and capacity to provide adequate rehabilitation to every Veteran seeking TKA in the VHA system. Additionally, if successful, this clinical decision support tool could be used to improve outcomes and access for additional patient populations in the future.
Detailed description
Rehabilitation after total knee arthroplasty (TKA) is typically generic and inefficient; most patients receive the same contents and dosage of rehabilitation regardless of the patients individual needs, preferences, or expectations. This generic treatment paradigm will be unsustainable in the Veterans Health Administration (VHA) as the demand for TKA surgery and postoperative care increase exponentially in the near future. Without new strategies to improve the efficiency of TKA rehabilitation, organizations like the VHA will struggle to meet and pay for this surging demand, and Veterans may be denied timely access to the postoperative care they need for optimal recovery. The investigators have developed an innovative new clinical decision support (CDS) tool to optimize efficiency in TKA rehabilitation. Using the actual recovery data of similar historical patients, the tool can predict the recovery trajectory for new patients after TKA. This allows clinicians to (1) allocate rehabilitation resources based upon individual need, (2) identify Veterans at risk for suboptimal outcomes early after surgery, (3) tailor treatment strategies to Veterans' unique goals and clinical presentation, and (4) monitor Veterans' recovery relative to expected throughout postoperative rehabilitation. In this project, the investigators propose to expand the CDS tool's capabilities by establishing utilization guidelines based upon individual Veteran's predicted recovery (Aim 1). These guidelines will be established by expert consensus in a three round Delphi process. Subsequently, the investigators will test the CDS tool's impact on Veteran's functional recovery and rehabilitation utilization in four VHA outpatient physical therapy clinics using a pre-post design (Aim 2). The investigators will compare patient-reported function (Knee Injury and Osteoarthritis Outcome Score, Joint Replacement) and physical therapy visit utilization between cohorts of Veterans treated with and without the CDS tool. Additionally, the investigators will gather data from participating VHA clinicians and Veterans regarding the translation of the investigators tool into clinical practice to assess its readiness for dissemination throughout the VHA (Aim 3). This will include qualitative data from participant focus groups and quantitative process data regarding the tool's utilization. Ultimately, the investigators expect this study will serve as a template for expanding the investigators tool's capabilities into numerous VHA populations in rehabilitation and beyond.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | –The investigators will collect outcomes for 100 Veterans treated with usual care rehabilitation after total knee arthroplasty. Data will be collected at all participating clinical locations. Data collection for these Veterans will precede data collection for the intervention cohort. |
| Intervention cohort | – | Other: Clinical decision support tool (CDS tool)The investigators will implement the clinical decision support tool in all participating clinic locations. We will collect outcomes for 100 Veterans treated in rehabilitation with use of the clinical decision support tool. Data collection for these Veterans will occur after data collection is complete for the Control cohort. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with total knee replacement who seek postoperative outpatient physical therapy treatment at the participating clinics
Key inclusion criteria (1 listed)
- -Veterans who have undergone total knee arthroplasty who present for outpatient rehabilitation treatment at the participating clinics within three weeks of surgery
Key exclusion criteria (1 listed)
- postoperative rehabilitation treatment received in the home health or skilled nursing
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 |
|---|---|---|
| Clinical decision support tool (CDS tool)Also: Knee Recovery ToolThe investigators will integrate the CDS tool into clinical practice at each participating clinic after data collection for the Control cohort is complete. All physical therapists at the participating clinic locations will use the CDS tool to inform rehabilitation decision making for Veterans with total knee arthroplasty. The CDS tool will provide personalized information regarding each Veterans' recovery in addition to personalized visit utilization guidelines. Clinicians will use the CDS tool with Veterans at their initial postoperative visits and every 2weeks throughout their course of care thereafter. | Other | Intervention cohort |
Primary outcome
Knee Injury and Osteoarthritis Outcome - Joint Replacement (KOOS, JR)
Time frame: Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)
The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness. KOOS JR will be assessed preoperatively at baseline and re-assessed at 90 (primary timepoint) and 180 days after TKA surgery. KOOS JR will also be assessed postoperatively throughout participants' rehabilitation episode at approximately 2-week intervals up to 180 days after surgery. We will use the interval scoring method for the KOOS JR which ranges from 0 (total knee disability) to 100 (perfect knee health)
Outpatient Physical Therapy Visit Utilization
Time frame: Postoperative day 90
The total outpatient physical therapy visits used in the first 90 postoperative days by each Veteran participant will be extracted from the electronic health record after the Veteran is formally discharged from outpatient rehabilitation. Any visits that occur prior to a Veteran's surgery or in the hospital setting will not count toward the total visit number. We chose postoperative day 90 as our primary endpoint because it corresponds with the average discharge timeframe for outpatient rehabilitation after total knee arthroplasty. Visit utilization will also be assed at at 30, 60, and 180 days after TKA surgery.
4 secondary outcomes
Lower Extremity Functional Scale (LEFS)
Time frame: Collected preoperatively at baseline with follow up assessments at 90 and 180 days after TKA surgery
Timed Up and Go (TUG)
Time frame: Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Knee range of motion (ROM)
Time frame: Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale
Time frame: Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. The research team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. All data released will be de-identified, with no information that could be linked to any study participants (patients and clinicians), or participating study practices to ensure the confidentiality of all participants and practices. If necessary, a data use agreement will be established.
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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.
Jennifer E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by VA Office of Research and Development 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 1 inclusion and 1 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 8 Oct 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?
Contact Jennifer E Stevens-Lapsley, PhD ((303) 949-9304, Jennifer.Stevens-Lapsley@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome - Joint Replacement (KOOS, JR) (time frame: Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)). 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 8 Oct 2026.