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

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Total Knee Arthroplasty using Robotic Arm; Device: Total Knee Arthroplasty using Manual Instrumentation

• Registration Number: NCT03106558
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Robitic arm total knee replacement	Total Knee Arthroplasty using Robotic Arm	-
Manual instrument total knee replacement	Total Knee Arthroplasty using Manual Instrumentation	-

Primary Outcome Measures

Name	Time	Method
Component alignment	6 weeks post knee arthroplasty	CT scan measurement

Trial Locations

Locations (3)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Athens Orthopedic Clinic; 🇺🇸 Athens, Georgia, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States