A Study to Compare the NexGen LPS and LPS-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 obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.

Key facts

Study ID

NCT00763386

Run by

Zimmer Biomet

People needed

331

Starts

2001-06-01

Expected to finish

2010-03-01

Last updated by the study team

2012-06-04

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, Males and females will be included
• BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
• Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
• Patient is willing and able to cooperate in follow-up therapy.
• Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
• Patient has stable and functional 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 90 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

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• VA Medical Center — Decatur, Georgia, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Joint Replacement Surgeons of Indiana — Indianapolis, Indiana, United States
• The Center for Hip and Knee Surgery — Mooresville, Indiana, United States
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• VSAS Orthopaedics — Allentown, Pennsylvania, United States
• Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States
• Piedmont Orthopaedic Associates — Greenville, South Carolina, United States
• Orthopaedic Specialists of Spartanburg — Spartanburg, South Carolina, United States
• Vanderbilt Orthopaedic Institute — Nashville, Tennessee, United States
• Rebecca Sealy Hospital — Galveston, Texas, United States
• The Rectors and Visitors of the University of Virginia — Charlottesville, Virginia, United States
• Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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