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
  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

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763386

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
Sponsors and Collaborators
Zimmer, Inc.
  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 October 01, 2014