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Gender Solutions Natural Knee Post-Market Study

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:
NCT01463566
First received: October 24, 2011
Last updated: March 21, 2012
Last verified: March 2012

October 24, 2011
March 21, 2012
January 2012
July 2024   (final data collection date for primary outcome measure)
Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse devices 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.
Same as current
Complete list of historical versions of study NCT01463566 on ClinicalTrials.gov Archive Site
  • Pain Performance [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Measured by comparing the overall pain performances (based on Knee Society Scoring System), Survivorship, subject quality of life and radiographic parameters.
  • Function Performance [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Measured by comparing the overall function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.
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.
Not Provided
Not Provided
 
Gender Solutions Natural Knee Post-Market Study
Prospective Multicenter Post-market Study of the Zimmer Gender Solutions Natural Knee Flex System

This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System 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 Gender Solutions Natural Knee Flex System.

Survival and outcome data on the Gender Solutions Natural Knee Flex System 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 Gender Solutions Natural Knee Flex System.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Osteoarthritis
  • Inflammatory Arthritis
  • Post-traumatic Arthritis
  • Rheumatoid Arthritis
  • Osteonecrosis
  • Varus or Valgus Deformities
Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
Gender Solutions Natural Knee Flex System in total knee arthroplasty
1 - Gender Natural Knee
Patients suffering from severe knee pain and disability.
Intervention: Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
300
January 2025
July 2024   (final data collection date for primary outcome measure)

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: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or 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 known sensitivity or allergy to one or more of the implanted materials;
  • Patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01463566
CMU2011-05K
No
Zimmer, Inc.
Zimmer, Inc.
Not Provided
Not Provided
Zimmer, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP