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Clinical and Economic Comparison of Robot Assisted Versus Manual Knee Replacement

NCT01705886 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2024-11-21

No results posted yet for this study

Summary

The purpose of this study is to document and compare the surgical and after surgery costs, recovery time, and outcomes of two procedure types:

* Robotic assisted surgery replacing one compartment of the knee
* Manual (robot is not used) surgery replacing all three compartments of the knee (total knee replacement)

The hypothesis is that robot assisted partial knee replacement is cost effective and provides clinical outcomes that are equivalent to a manual total knee replacement.

Conditions

  • Knee Arthroplasty

Interventions

PROCEDURE

Total Knee Arthroplasty

Patients undergoing manual (no robot used) surgery to replace of all 3 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

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 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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-01-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705886 on ClinicalTrials.gov