Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

Rothman Institute Orthopaedics3 sites in 1 country400 target enrollmentJune 2016

ConditionsOsteoarthritis, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Rothman Institute Orthopaedics
Enrollment: 400
Locations: 3
Primary Endpoint: Component alignment
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Rothman Institute Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient requires primary total knee surgery
•Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
•Patient is willing to sign an IRB approved informed consent
•Patient is at least 18 years of age

Exclusion Criteria

•Patient has a BMI \> 50
•Patient is skeletally immature
•Patient has an active infection or suspected infection in or about the joint
•Bone stock that is inadequate to support fixation of the prosthesis
•Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
•Patients with mental or neurological conditions which may be incapable of following instructions.
•Blood supply limitations
•Collateral ligament insufficiency.
•Patients with prior HTOs or Unis.