A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Total Knee Arthroplasty Osteoarthritis |
Device: NexGen LPS-Flex Fixed Bearing Knee Device: NexGen Legacy Posterior Stabilized Knee |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee |
- 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.
- 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.
| Enrollment: | 331 |
| Study Start Date: | June 2001 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
Device: NexGen LPS-Flex Fixed Bearing Knee
NexGen LPS-Flex Fixed Bearing femoral component
Other Name: LPS-Flex Knee
|
|
Active Comparator: 2
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
Device: NexGen Legacy Posterior Stabilized Knee
NexGen Legacy Posterior Stabilized femoral component
Other Name: LPS Knee
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Georgia | |
| VA Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794 | |
| United States, Indiana | |
| Joint Replacement Surgeons of Indiana | |
| Indianapolis, Indiana, United States, 46260 | |
| The Center for Hip and Knee Surgery | |
| Mooresville, Indiana, United States, 46158 | |
| United States, North Carolina | |
| OrthoCarolina Research Institute | |
| Charlotte, North Carolina, United States, 28209 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| VSAS Orthopaedics | |
| Allentown, Pennsylvania, United States, 18103 | |
| Albert Einstein Healthcare Network | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| United States, South Carolina | |
| Piedmont Orthopaedic Associates | |
| Greenville, South Carolina, United States, 29615 | |
| Orthopaedic Specialists of Spartanburg | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Vanderbilt Orthopaedic Institute | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Rebecca Sealy Hospital | |
| Galveston, Texas, United States, 77555 | |
| United States, Virginia | |
| The Rectors and Visitors of the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Canada, Quebec | |
| Hopital du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J1C5 | |
More Information
No publications provided
| Responsible Party: | Zimmer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00763386 History of Changes |
| Other Study ID Numbers: | 00-500 |
| Study First Received: | September 26, 2008 |
| Results First Received: | December 13, 2011 |
| Last Updated: | May 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zimmer, Inc.:
|
Total Knee Arthroplasty Osteoarthritis Knee |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013