Total Knee Arthroplasty Outcome Study

MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: MIS™ Minimally Invasive Solutions™ TKA System

Detailed Description

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.

You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.

The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.

• Study Type: Interventional
• Phase: Phase 4

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:

• Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
• Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
• Age - Minimum of 18 years-old.
• Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
• Patient or patient's legal representative has read and signed the Letter to the Patient form.

Exclusion Criteria:

• Patient is skeletally immature.
• Previous ipsilateral knee arthroplasty.
• Previous Patellectomy.
• Patient is pregnant or breastfeeding.
• Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
• Patients who have received an investigational drug or device within the last 30 days.
• Patient is unwilling or unable to cooperate in a follow-up program.

Study Plan

How is the study designed?

Design Details

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Richard G. Vlasak, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): May 2, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 580-2004