Clinical Outcomes of Knee Replacement

Summary

The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.

The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.

Conditions

• Knee Arthroplasty

Interventions

PROCEDURE

Non-MAKO® Robot Assisted Total Knee Arthroplasty

Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.

PROCEDURE

MAKO® Robot Assisted Medial Knee Arthroplasty

Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.

PROCEDURE

MAKO® Robot Assisted Medial and PF Knee Arthroplasty

Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee

DEVICE

RESTORIS Multicompartmental Knee System

The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.

DEVICE

Depuy Knee Replacement System

The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.

DEVICE

Stryker® Knee Replacement System

The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.

Sponsors & Collaborators

• Stryker MAKO Surgical Corp

  collaborator UNKNOWN

• Northwest Surgical Specialists, Vancouver

  lead OTHER

Principal Investigators

• Todd Borus, MD · Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery

• Donald Roberts, MD · Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2018-09-19

Completion

2018-09-19

Countries

• United States

Study Locations