Trials / Withdrawn
WithdrawnNCT01463566
Gender Solutions Natural Knee Post-Market Study
Prospective Multicenter Post-market Study of the Zimmer Gender Solutions Natural Knee Flex System
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Osteoarthritis
- Inflammatory Arthritis
- Post-traumatic Arthritis
- Rheumatoid Arthritis
- Osteonecrosis
- Varus or Valgus Deformities
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System | Gender Solutions Natural Knee Flex System in total knee arthroplasty |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2024-07-01
- Completion
- 2025-01-01
- First posted
- 2011-11-02
- Last updated
- 2019-01-09
Source: ClinicalTrials.gov record NCT01463566. Inclusion in this directory is not an endorsement.