A Study to Compare the NexGen CR and CR-Flex Knee Implants

Completed · Not applicable

Conditions studied: Total Knee Arthroplasty, Osteoarthritis

In brief

The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.

Key facts

Study ID

NCT00761956

Run by

Zimmer Biomet

People needed

189

Starts

2004-09-01

Expected to finish

2010-12-01

Last updated by the study team

2012-07-16

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age, 21-80 years
• Sex, Male and Females will be included
• BMI less than or equal to 39
• Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
• Patient is willing and able to cooperate in follow-up therapy.
• Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
• Patient has stable and functional posterior cruciate and collateral ligaments.
• Patient has potential to perform higher than average range of motion activities.
• Operative side range of motion flexion greater than or equal to 120 degrees.
• Severe knee pain and disability due to degenerative joint disease.
• Patient or patient's legal representative has signed the Informed Consent form.

You may not qualify if…

• Previous history of infection in the affected joint.
• Previously failed knee endoprosthesis of any kind.
• Charcot joint disease or other severe neurosensory deficits.
• Previous patellectomy
• Patient is skeletally immature.
• Grossly insufficient femoral or tibial bone stock.
• Patient is pregnant.
• Varus or valgus deformity greater than 20 degrees.
• Fixed flexion deformity greater than 15 degrees.
• Previous high tibial osteotomy.
• Previous femoral osteotomy.
• Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
• Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.

Where it is running

• Dickinson Medical Group, LLC — Milford, Delaware, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• Rockford Orthopedic Associates — Rockford, Illinois, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Orthopaedic Associates of Grand Rapids, PC — Grand Rapids, Michigan, United States
• Pinehurst Surgical Center — Pinehurst, North Carolina, United States
• Slocum Orthopedics, PC — Eugene, Oregon, United States
• The Orthopedic Group — Clairton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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