Status:
WITHDRAWN
Gender Solutions Natural Knee Post-Market Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Inflammatory Arthritis
Eligibility:
All Genders
18-75 years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01463566
Start Date
January 1 2012
End Date
January 1 2025
Last Update
January 9 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.