A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements

Virtua Health, Inc.1 site in 1 country92 target enrollmentApril 20, 2018

ConditionsPrimary Osteoarthritis of Knee Nos

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Osteoarthritis of Knee Nos
Sponsor: Virtua Health, Inc.
Enrollment: 92
Locations: 1
Primary Endpoint: Patient Reported Forgotten Joint Score (FJS)
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:

Patients' self-reported awareness of their artificial joints during activities of daily living;
Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
The accuracy of implant placement and limb alignment

Registry

clinicaltrials.gov

Start Date

April 20, 2018

End Date

July 14, 2022

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Virtua Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 or older
•Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
•Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria

•Pregnant or contemplating pregnancy prior to surgery;
•Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
•Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
•Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

Outcomes

Primary Outcomes

Patient Reported Forgotten Joint Score (FJS)

Time Frame: 1 year

The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)