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

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ClinicalTrials.gov Identifier: NCT00854295
Recruitment Status : Active, not recruiting
First Posted : March 3, 2009
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Traumatic Arthritis Avascular Necrosis of the Femoral Condyle Moderate Varus Valgus Flexion Deformities Device: NexGen LPS-Flex Mobile Bearing Knee Not Applicable

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 and has completed t his portion of the study. Group 2 will be followed through a total of 5 years from the date of surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Actual Study Start Date : April 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854295


Locations
United States, Florida
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
United States, Michigan
Advanced Orthopaedics
Auburn Hills, Michigan, United States, 48236-2776
United States, Tennessee
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, United States, 37923
Sponsors and Collaborators
Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00854295     History of Changes
Other Study ID Numbers: 07-100
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Zimmer Biomet:
arthritis
osteoarthritis
degenerative knee disease
avascular necrosis
total knee replacement
TKA

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