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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical decision support tool (CDS tool)

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control cohort0 interventions
Group B: Intervention cohort1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)
2

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.

Time frame
Postoperative day 90

Secondary outcomes

1

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).

Time frame
Collected preoperatively at baseline with follow up assessments at 90 and 180 days after TKA surgery
2

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.

Time frame
Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
3

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.

Time frame
Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
4

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).

Time frame
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery

Other outcomes

1

Veterans Rand 12-item Health Survey (VR-12)

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.

Time frame
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery

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