Status:
WITHDRAWN
Total Knee Arthroplasty Outcome Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Total Knee Replacement
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.
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 Sys...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00160797
Start Date
August 1 2005
End Date
October 1 2005
Last Update
May 2 2012
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