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

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: Total Knee Arthroplasty using Robotic Arm; Device: Total Knee Arthroplasty using Manual Instrumentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03106558

2017WHoz

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Manual instrument total knee replacement

Active Comparator group

Treatment:

Device: Total Knee Arthroplasty using Manual Instrumentation

Robitic arm total knee replacement

Active Comparator group

Treatment:

Device: Total Knee Arthroplasty using Robotic Arm