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OpenTrials
Completed

NCT Number: NCT05900453

Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.

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Key information

Conditions

Total Knee Replacement

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ATI Physical Therapy

Greenville, South Carolina, 29601, United States

About this study

In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient underwent TKA for primary knee osteoarthritis
  • Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area

Exclusion criteria

  • Patients < 40 years old
  • Patients whose total episode of care length in outpatient physical therapy was < 21 days
  • Patients who attended < 3 outpatient physical therapy visits throughout their episode of care
  • Outcomes collected > 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery)
  • Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool

Treatment and study plan

Clinical decision support (CDS) tool

Other

The web-based clinical decision support (CDS) tool uses patient information (e.g., age, sex, BMI, perioperative status) to create personalized predictions of recovery following knee replacement. The CDS tool predicts range of motion, physical function, and pain recovery. Clinicians can use these predictions to (1) inform patients of their expected prognosis, (2) monitor patients' recovery against their predicted recovery, and (3) tailor treatments according to individual patients' needs.

Clinicians were provided with basic training for how to use the CDS tool, and were given examples of how to integrate it into clinical care. However, the CDS tool did not dictate any treatment decisions; clinicians were free to use the CDS tool at their discretion to inform decision making.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)

    Time frame: KOOS-JR was assessed postoperatively up to 6 months after surgery

    The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty (TKA). The KOOS-JR is scored on a 100-point scale with 0 representing complete knee disability and 100 representing perfect knee health. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness in the TKA population.

Secondary outcomes

  1. Outpatient Physical Therapy Visit Utilization

    Time frame: All visits from initial evaluation to discharge up to 1 year after surgery

    The total number of outpatient physical therapy visits attended by each patient during the year immediately following their TKA will be extracted from the electronic medical record. Only visits associated with the patient's episode of care for TKA will be included.

  2. Time Up and Go (TUG)

    Time frame: TUG was assessed postoperatively up to 6 months after surgery

    The TUG is a basic measure of mobility and balance that 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 TKA.

  3. Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.

    Time frame: Surveys were assessed postoperatively up to 6 months after surgery

    Patients completed surveys regarding their perceived knowledge of their postoperative recovery and their engagement in rehabilitation decision making. The surveys were scored on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).

  4. Knee range of motion (ROM)

    Time frame: ROM was assessed postoperatively up to 6 months after surgery

    Knee flexion and extension ROM was measured manually by goniometry, which is a valid and reliable technique for measuring knee mobility. Recovery of ROM after TKA is necessary for many functional activities and is emphasized in rehabilitation after TKA.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • ATI Physical Therapy

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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