A Study to Compare the NexGen CR and CR-Flex Knee Implants
Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
1 other identifier
interventional
189
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
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, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
July 16, 2012
CompletedJuly 16, 2012
June 1, 2012
6.3 years
September 26, 2008
April 2, 2012
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Range of Motion (ROM)
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
24 Months
Secondary Outcomes (1)
Return to Function (RtF) Via Knee Scoiety Score (Modified)
24 Months
Study Arms (2)
1
ACTIVE COMPARATORStudy arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
2
ACTIVE COMPARATORStudy arm will consist of patients that are treated with the NexGen CR Knee.
Interventions
NexGen CR-Flex Fixed Bearing femoral component
NexGen Complete Knee Solution Cruciate Retaining femoral component
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (8)
Dickinson Medical Group, LLC
Milford, Delaware, 19963, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Orthopaedic Associates of Grand Rapids, PC
Grand Rapids, Michigan, 49525, United States
Pinehurst Surgical Center
Pinehurst, North Carolina, 28374, United States
Slocum Orthopedics, PC
Eugene, Oregon, 97401, United States
The Orthopedic Group
Clairton, Pennsylvania, 15025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kacy Arnold, Associate Director, Clinical Affairs
- Organization
- Zimmer, Inc
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
September 1, 2004
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 16, 2012
Results First Posted
July 16, 2012
Record last verified: 2012-06