A Study to Compare the NexGen CR and CR-Flex Knee Implants
NCT ID: NCT00761956
Last Updated: 2012-07-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
189 participants
INTERVENTIONAL
2004-09-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
NexGen CR-Flex Fixed Bearing Knee
NexGen CR-Flex Fixed Bearing femoral component
2
Study arm will consist of patients that are treated with the NexGen CR Knee.
NexGen CR Knee
NexGen Complete Knee Solution Cruciate Retaining femoral component
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NexGen CR-Flex Fixed Bearing Knee
NexGen CR-Flex Fixed Bearing femoral component
NexGen CR Knee
NexGen Complete Knee Solution Cruciate Retaining femoral component
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04-300
Identifier Type: -
Identifier Source: org_study_id