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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zimmer, Inc.

ClinicalTrials.gov Identifier:

NCT00763386

First received: September 26, 2008

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 26, 2008
Last Updated Date	May 25, 2012
Start Date ^ICMJE	June 2001
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 24, 2012)	Postoperative Range of Motion (ROM) [ Time Frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed ] [ Designated as safety issue: No ] Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
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 NCT00763386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 25, 2012)	Return to Function (RtF) Via Knee Society Score (Modified) [ Time Frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed ] [ 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 established 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 LPS and LPS-Flex Knee Implants
Official Title ^ICMJE	Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
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.
Detailed Description	This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative 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 LPS-Flex Fixed Bearing Knee NexGen LPS-Flex Fixed Bearing femoral component Other Name: LPS-Flex Knee Device: NexGen Legacy Posterior Stabilized Knee NexGen Legacy Posterior Stabilized femoral component Other Name: LPS Knee
Study Arm (s)	Active Comparator: 1 Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. Intervention: Device: NexGen LPS-Flex Fixed Bearing Knee Active Comparator: 2 Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. Intervention: Device: NexGen Legacy Posterior Stabilized 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	331
Completion Date	March 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. 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, Canada

Administrative Information
NCT Number ^ICMJE	NCT00763386
Other Study ID Numbers ^ICMJE	00-500
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	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top