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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Total Knee Arthroplasty using Manual Instrumentation; Device: Total Knee Arthroplasty using Robotic Arm

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens Orthopedic Clinic
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • Rothman Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual instrument total knee replacement	Device: Total Knee Arthroplasty using Manual Instrumentation
Active Comparator: Robitic arm total knee replacement	Device: Total Knee Arthroplasty using Robotic Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component alignment	CT scan measurement	6 weeks post knee arthroplasty

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Collaborators: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2017WHoz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes