Total Knee Arthroplasty Outcome Study - Full Text View

Sponsors and Collaborators:	University of Florida Zimmer, Inc.
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00160797

Purpose

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

Condition	Intervention	Phase
Total Knee Replacement	Device: MIS™ Minimally Invasive Solutions™ TKA System	Phase IV

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800

Further study details as provided by University of Florida:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

x-rays: post surgery, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
overall health questionnaire
questionnaire about affected knee to include: pain, strength, and functional level

Estimated Enrollment:

700

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160797

Locations

United States, Florida
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Zimmer, Inc.

Investigators

Principal Investigator:

Richard G. Vlasak, M.D.

University of Florida

More Information

Study ID Numbers:	580-2004
Study First Received:	September 8, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00160797
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009