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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Osteonecrosis; Inflammatory Arthritis; Post-traumatic Arthritis; Varus or Valgus Deformities
• Intervention / Treatment: Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Performance	Measured by comparing the overall pain performances (based on Knee Society Scoring System), Survivorship, subject quality of life and radiographic parameters.	10 years
Function Performance	Measured by comparing the overall function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.	10 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: arthritis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Joint Diseases; Musculoskeletal Diseases; Bone Diseases; Arthritis; Osteonecrosis
• Other Study ID Numbers: CMU2011-05K