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

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03106558

Run by

Rothman Institute Orthopaedics

People needed

400

Starts

2016-06-01

Expected to finish

2019-06-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Athens Orthopedic Clinic — Athens, Georgia, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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