Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

The University of Texas Health Science Center, Houston1 site in 1 countryJuly 1, 2018

ConditionsKnee Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Arthritis
Sponsor: The University of Texas Health Science Center, Houston
Locations: 1
Primary Endpoint: Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

December 1, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Adam M Freedhand

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Patients who have knee pain and are candidates for total knee arthroplasty
•Patients able to consent to be included in the study

Exclusion Criteria

•Patients with previous total or partial knee arthroplasty in need of revision surgery
•Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits

Outcomes

Primary Outcomes

Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)

Time Frame: within 2 weeks before surgery, within one month of surgery

The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.

Secondary Outcomes

Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system(1 year after surgery)
Pain as assessed by a Visual Analogue Scale (VAS)(1 year after surgery)
Function as assessed by the PROMIS 10 measurement system(1 year after surgery)
Pain as assessed by the PROMIS 10 measurement system(1 year after surgery)