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Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05900453
Enrollment
675
Registered
2023-06-12
Start date
2018-05-15
Completion date
2022-12-30
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

Keywords

precision medicine, prognosis, patient-centered care, Decision Support Systems, Clinical

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

ATI Physical Therapy
CollaboratorUNKNOWN
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)KOOS-JR was assessed postoperatively up to 6 months after surgeryThe 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

MeasureTime frameDescription
Outpatient Physical Therapy Visit UtilizationAll visits from initial evaluation to discharge up to 1 year after surgeryThe 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.
Time Up and Go (TUG)TUG was assessed postoperatively up to 6 months after surgeryThe 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.
Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.Surveys were assessed postoperatively up to 6 months after surgeryPatients 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).
Knee range of motion (ROM)ROM was assessed postoperatively up to 6 months after surgeryKnee 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026