LPS Flex Porous Femoral Components

This study has suspended participant recruitment.
(Suspended pending internal review/direction of the company's focus.)
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01462240
First received: October 24, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Poly Arthritis
Collagen Disorders
Avascular Necrosis of Femoral Condyle
Device: LPS Flex Porous Femoral Components

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals.


Secondary Outcome Measures:
  • Pain and Functional Performance [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.


Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 - LPS-Flex Pororus Femoral Components
Patients suffering from severe knee pain and disability.
Device: LPS Flex Porous Femoral Components
Porous femoral components in total knee arthroplasty

Detailed Description:

Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Each investigator will screen from this patient populatin patients suffering from severe knee pain and disability who meet the inclusion/exclusion criteria for study participation.

Criteria

Inclusion Criteria:

  • Patient 18-75 years of age, inclusive;
  • Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle;
  • Post-Traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
  • Moderate valgus, varus, or flexion deformities;
  • Patient has undergone a study related informed consent process;
  • Patient is willing and able to provide written consent;
  • Patient is willing and able to cooperate in the required post-operative therapy;
  • Patient is willing and able to complete scheduled follow-up evaluations.

Exclusion Criteria:

  • Patient has previous history of infection in the affected joint and/or a local or systemic infection that could 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;
  • Stable, painless arthrodesis in a satisfactory functional position;
  • Severe instability secondary to the absence of collateral ligament integrity;
  • Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
  • Patient has a known sensitivity or allergy to one or more of the implanted materials;
  • Patient is pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01462240     History of Changes
Other Study ID Numbers: CMU2010-27K
Study First Received: October 24, 2011
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Collagen Diseases
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on July 31, 2014