Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00854295
First received: February 26, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.


Condition Intervention
Osteoarthritis
Traumatic Arthritis
Avascular Necrosis of the Femoral Condyle
Moderate Varus
Valgus
Flexion Deformities
Device: NexGen LPS-Flex Mobile Bearing Knee

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Functional analysis (Knee Scores) [ Time Frame: Group 1 - annual visits for 5 years; Group 2: Pre-op, 6 week, 6 month, and annual for a total of 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic analysis [ Time Frame: Group 1: annual visits for a total of 5 years; Group 2: Pre-op, 6 week, 6 month and annual for a total of 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Follow-up of existing IDE study subjects
Device: NexGen LPS-Flex Mobile Bearing Knee
Total Knee Replacement
Other Name: Mobile bearing knee
2
Newly enrolled study subjects
Device: NexGen LPS-Flex Mobile Bearing Knee
Total Knee Replacement
Other Name: Mobile bearing knee

Detailed Description:

The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed through a total of 10 years from the date of surgery. Group 2 will be followed through a total of 5 years from the date of surgery.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Osteoarthritis
  • Primary and secondary traumatic arthritis
  • Avascular necrosis of the femoral condyle
  • Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)

Exclusion Criteria:

  • Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
  • Insufficient bone stock on femoral or tibial surfaces
  • Skeletal immaturity
  • Neuropathic arthropathy
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  • A stable, painless arthrodesis in a satisfactory functional position
  • Severe instability secondary to the absence of collateral integrity
  • Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.
  • Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up
  • Patient is not willing or able to give informed consent to participate in the follow-up program
  • Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.
  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: NCT00854295

Locations
United States, Arizona
Tucson Orthopaedic Institute, PC
Tucson, Arizona, United States, 85741
United States, California
UC Davis School of Medicine
Sacramento, California, United States, 95817
United States, Colorado
Western Orthopaedics
Denver, Colorado, United States, 80218
United States, Florida
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
United States, Idaho
ADA Orthopaedic Clinic
Boise, Idaho, United States, 83704
United States, Illinois
Mitchell Sheinkop, MD
Chicago, Illinois, United States, 60640
United States, Michigan
Rochester Knee and Sports Medicine, PC
Auburn Hills, Michigan, United States, 48236-2776
United States, New Jersey
Hartzband Joint Replacement Institute
Paramus, New Jersey, United States, 07652
United States, New York
ISK Institute
New York, New York, United States, 10021
United States, North Carolina
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
United States, Tennessee
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, United States, 37923
Canada, Manitoba
Concordia Joint Replacement Group
Winnipeg, Manitoba, Canada, R2K 2M9
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00854295     History of Changes
Other Study ID Numbers: 07-100
Study First Received: February 26, 2009
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
arthritis
osteoarthritis
degenerative knee disease
avascular necrosis
total knee replacement
TKA

Additional relevant MeSH terms:
Congenital Abnormalities
Arthritis
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014