Knee ArthritisNCT02831595
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
An observational study of Knee Arthritis, run by Permedica spa.
Trial summary
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions. Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jan 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA
Who may be able to join
- Patients candidate for unilateral primary total knee arthroplasty
Who cannot join
- Existing orthopaedic metal implants
- A history of hypersensitivity to metals
- Preoperative patch-test positivity to Co, Cr, Ni and Ti
- Malignancies
- Renal insufficiency
- Severe illnesses that would impair participation in this study
About this study
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.
Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.
The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
- Conditions
- Knee Arthritis
- Being tested
- GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing unilateral TKA | Not described Receives: Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months
Measured: Preoperative and at 12 months follow-up
Secondary outcomes (1)
Number of patients with metal sensitivity at 1 year tested by patch-testing
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Enrollment stopped for missing availability of the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Permedica spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Ursino, MD, Principal investigator, IRCCS Istituto Ortopedico Galeazzi Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831595
- Sponsor's protocol ID
- VCG-30-2015
- Status last verified
- Oct 2019
- First submitted
- 29 Jun 2016
- Last updated
- 23 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02831595
- Acronym / sponsor ID
- VCG-30-2015
- Conditions
- Knee Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment stopped for missing availability of the site
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Permedica spaIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 13 Jul 2016 (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.
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.
Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.
The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing unilateral TKA | – | Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA
Key inclusion criteria (1 listed)
- Patients candidate for unilateral primary total knee arthroplasty
Key exclusion criteria (6 listed)
- Existing orthopaedic metal implants
- A history of hypersensitivity to metals
- Preoperative patch-test positivity to Co, Cr, Ni and Ti
- Malignancies
- Renal insufficiency
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 |
|---|---|---|
| GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis | Device | Patients undergoing unilateral TKA |
Primary outcome
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months
Time frame: Preoperative and at 12 months follow-up
1 secondary outcome
Number of patients with metal sensitivity at 1 year tested by patch-testing
Time frame: 1 year follow-up
Results and safety
The study was stopped early (reason given: Enrollment stopped for missing availability of the site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Nicola Ursino, MD principal investigator
IRCCS Istituto Ortopedico Galeazzi Milano, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthritis, run by Permedica spa.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Oct 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 stopped early (reason given: Enrollment stopped for missing availability of the site). Results are not available in the source record.
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?
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months (time frame: Preoperative and at 12 months follow-up). 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 23 Oct 2019.