NCT01463566

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

12.5 years

First QC Date

October 24, 2011

Last Update Submit

January 8, 2019

Conditions

OsteoarthritisInflammatory ArthritisPost-traumatic ArthritisRheumatoid ArthritisOsteonecrosisVarus or Valgus Deformities

Keywords

arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain Performance

    10 years

  • Function Performance

    10 Years

Study Arms (1)

1 - Gender Natural Knee

Patients suffering from severe knee pain and disability.

Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System

Interventions

Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex SystemDEVICE

Gender Solutions Natural Knee Flex System in total knee arthroplasty

1 - Gender Natural Knee

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisArthritisArthritis, RheumatoidOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kacy Arnold, RN, MBA

    Zimmer Biomet

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

November 2, 2011

Study Start

January 1, 2012

Primary Completion

July 1, 2024

Study Completion

January 1, 2025

Last Updated

January 9, 2019

Record last verified: 2019-01