A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
1 other identifier
interventional
331
2 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2001
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
May 25, 2012
CompletedJune 4, 2012
May 1, 2012
8.5 years
September 26, 2008
December 13, 2011
May 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Range of Motion (ROM)
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
6 Weeks to 2 Years Post-op, based on on the intervals listed
Secondary Outcomes (1)
Return to Function (RtF) Via Knee Society Score (Modified)
6 Weeks to 2 Years Post-op, based on on the intervals listed
Study Arms (2)
1
ACTIVE COMPARATORStudy arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
2
ACTIVE COMPARATORStudy arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
Interventions
NexGen LPS-Flex Fixed Bearing femoral component
NexGen Legacy Posterior Stabilized femoral component
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
VA Medical Center
Decatur, Georgia, 30033, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794, United States
Joint Replacement Surgeons of Indiana
Indianapolis, Indiana, 46260, United States
The Center for Hip and Knee Surgery
Mooresville, Indiana, 46158, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, 28209, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
VSAS Orthopaedics
Allentown, Pennsylvania, 18103, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
Piedmont Orthopaedic Associates
Greenville, South Carolina, 29615, United States
Orthopaedic Specialists of Spartanburg
Spartanburg, South Carolina, 29303, United States
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232, United States
Rebecca Sealy Hospital
Galveston, Texas, 77555, United States
The Rectors and Visitors of the University of Virginia
Charlottesville, Virginia, 22908, United States
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kacy Arnold, Associate Director, Clinical Affairs
- Organization
- Zimmer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
June 1, 2001
Primary Completion
December 1, 2009
Study Completion
March 1, 2010
Last Updated
June 4, 2012
Results First Posted
May 25, 2012
Record last verified: 2012-05