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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zimmer, Inc.

ClinicalTrials.gov Identifier:

NCT00761956

First received: September 26, 2008

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 26, 2008
Last Updated Date	June 12, 2012
Start Date ^ICMJE	September 2004
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 12, 2012)	Postoperative Range of Motion (ROM) [ Time Frame: 24 Months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: September 29, 2008)	Postoperative range of motion [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00761956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 12, 2012)	Return to Function (RtF) Via Knee Scoiety Score (Modified) [ Time Frame: 24 Months ] [ Designated as safety issue: No ] Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Original Secondary Outcome Measures ^ICMJE (submitted: September 29, 2008)	Return to function [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Compare the NexGen CR and CR-Flex Knee Implants
Official Title ^ICMJE	Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
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.
Detailed Description	This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Total Knee Arthroplasty Osteoarthritis
Intervention ^ICMJE	Device: NexGen CR-Flex Fixed Bearing Knee NexGen CR-Flex Fixed Bearing femoral component Other Name: CR-Flex Knee Device: NexGen CR Knee NexGen Complete Knee Solution Cruciate Retaining femoral component Other Name: CR Knee
Study Arm (s)	Active Comparator: 1 Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. Intervention: Device: NexGen CR-Flex Fixed Bearing Knee Active Comparator: 2 Study arm will consist of patients that are treated with the NexGen CR Knee. Intervention: Device: NexGen CR Knee
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	189
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	21 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00761956
Other Study ID Numbers ^ICMJE	04-300
Has Data Monitoring Committee	No
Responsible Party	Zimmer, Inc.
Study Sponsor ^ICMJE	Zimmer, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Zimmer, Inc.
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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