Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories

March 20, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
        • Principal Investigator:
          • Jennifer E. Stevens-Lapsley, PhD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Recruiting
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Veterans with total knee replacement who seek postoperative outpatient physical therapy treatment at the participating clinics.

Description

Inclusion Criteria:

-Veterans who have undergone total knee arthroplasty who present for outpatient rehabilitation treatment at the participating clinics within three weeks of surgery.

Exclusion Criteria:

  • postoperative rehabilitation treatment received in the home health or skilled nursing
  • age < 40 or >90

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Clinical decision support tool (CDS 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.
Other Names:
  • Knee Recovery Tool

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 90
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)
Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower Extremity Functional Scale (LEFS)
Time Frame: Collected preoperatively at baseline with follow up assessments at 90 and 180 days after TKA surgery
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).
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
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.
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
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.
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
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).
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Veterans Rand 12-item Health Survey (VR-12)
Time Frame: Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery
The VR-12 mental component summary score will be used to capture emotional/psychosocial variables which could impact Veteran recovery and/or healthcare utilization after total knee arthroplasty. The VR-12 mental component summary score will be included as a potential confounder in our Aim 2 analysis plan. The VR-12 includes both a Mental Component Score (MCS) and Physical Component Score (PCS). Both scores can be reported as z-scores for the population average in the United States. The population average for both scores is 50, and each 10-point increment above or below 50 corresponds to 1 standard deviation away from the population average.
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer E. Stevens-Lapsley, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F3770-R
  • I01RX003770 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available after the main study results are published.

IPD Sharing Access Criteria

Data will be available after the main study results are published for up to 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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