OsteoarthritisNCT01463566
Gender Solutions Natural Knee Post-Market Study
An observational study of Osteoarthritis and Inflammatory Arthritis, run by Zimmer Biomet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis
- What is being tested?
- Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.)
About this study
Official title: 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.
Read the 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
- Being tested
- Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
- Keywords
- arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex SystemDevice
Gender Solutions Natural Knee Flex System in total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 - Gender Natural Knee | Patients suffering from severe knee pain and disability. Receives: Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (2)
Pain Performance
Measured by comparing the overall pain performances (based on Knee Society Scoring System), Survivorship, subject quality of life and radiographic parameters.
Measured: 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.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Suspended pending internal review/direction of the company's focus.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, RN, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463566
- Sponsor's protocol ID
- CMU2011-05K
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2011
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Post-market Study of the Zimmer Gender Solutions Natural Knee Flex System
- ClinicalTrials.gov ID
- NCT01463566
- Acronym / sponsor ID
- CMU2011-05K
- Conditions
- Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Osteonecrosis, Varus or Valgus Deformities
- Keywords
- arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Suspended pending internal review/direction of the company's focus.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 - Gender Natural Knee | – | Device: Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex SystemPatients suffering from severe knee pain and disability. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex SystemGender Solutions Natural Knee Flex System in total knee arthroplasty | Device | 1 - Gender Natural Knee |
Primary outcome
Survivorship
Time frame: 10 years
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.
2 secondary outcomes
Pain Performance
Time frame: 10 years
Function Performance
Time frame: 10 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kacy Arnold, RN, MBA study director
Zimmer Biomet
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Inflammatory Arthritis, run by Zimmer Biomet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.