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
  Purpose

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.


Condition Intervention
Osteoarthritis
Inflammatory Arthritis
Post-traumatic Arthritis
Rheumatoid Arthritis
Osteonecrosis
Varus or Valgus Deformities
Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Multicenter Post-market Study of the Zimmer Gender Solutions Natural Knee Flex System

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 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 - Gender Natural Knee
Patients suffering from severe knee pain and disability.
Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
Gender Solutions Natural Knee Flex System in total knee arthroplasty

Detailed Description:

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.

  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 his patient population 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: 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.)
  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: NCT01463566     History of Changes
Other Study ID Numbers: CMU2011-05K
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
Osteoarthritis
Osteonecrosis
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Rheumatic Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014