Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900453
• Other study ID #: 18-1246
• Status: Completed
• Start date: May 15, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Other:
• Clinical decision support (CDS) tool
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.

Locations

Country	Name	City	State
United States	ATI Physical Therapy	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	ATI Physical Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)	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.	KOOS-JR was assessed postoperatively up to 6 months after surgery
Secondary	Outpatient Physical Therapy Visit Utilization	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.	All visits from initial evaluation to discharge up to 1 year after surgery
Secondary	Time Up and Go (TUG)	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.	TUG was assessed postoperatively up to 6 months after surgery
Secondary	Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.	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).	Surveys were assessed postoperatively up to 6 months after surgery
Secondary	Knee range of motion (ROM)	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.	ROM was assessed postoperatively up to 6 months after surgery