Total Knee ArthroplastyNCT04801654
GMK Sphere TiNb Total Knee Arthroplasty PMS Study
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site in Italy.
Trial summary
Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- blood sample
- How many people
- 155 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2020to 5 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample size calculation has been performed according to one proportion test comparing expected survival at 10 year of 96.3%[5] with the bench mark value defined by ODEP Panel for a total knee arthroplasty at 10 yrs of 90%. With a significance level of 5% and a power of 80%, 141 patients are necessary to show a non-inferiority test. Considering a lost to follow-up rate of 10%, 155 patients will be recruited. B. Bordini, C. Ancarani, and D. A. Fitch, "Long-term survivorship of a medial-pivot total knee system compared with other cemented designs in an arthroplasty registry," Journal of orthopaedic surgery and research, vol. 11, no. 1, p. 44, 2016
Who may be able to join
- Those older than 18 years old at the surgery time
- those suitable to undergo to a primary total knee arthroplasty for whom the GMK Sphere TiNb coated device will be implanted (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery
Who cannot join
- Those patients with metal implants containing Co, Cr and / or Ni
- Those patients who have had environmental or occupational exposure to toxic metals such as Co, Cr and / or Ni (solvents, industrial paints, welders)
- Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups
- Those unable to give their consent to participate in the study or who do not want to participate
- Any condition not mentioned in inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi di Milano Sede di via Monreale18 (Istituto Clinico San Siro)
Milan, MI, 20148
Marco Attanasio, Dr, marco attanasio <marco.attanasio87@gmail.com>
About this study
Official title: A Monocentric, Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty
Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray.
Recently there has been particular attention on the component material; traditionally femoral components are made of cobalt alloys while tibial baseplates are made, in the great majority of cases, of metallic materials, but also polyethylene versions are available. There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report, making up for 5.9% of all revisions. The wording was subsequently changed from "metal sensitivity" to "metal related pathology" in the 2014 report with 0.5% of all revision total hip arthroplasties (THA) associated with this term. The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 1.3% of revisions in 2012 and in 2014, 1.8% of revision TKAs attributed to "metal related pathology" . The overall revision rate was 3.45% after 10 years in 396.472 TKAs, suggesting a revision rate of 0.06-0.32% secondary to metal or cement allergies. Up to today there is no question that metallic implants may generate wear debris that cause local reactions. This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process. Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction. To prevent issues arising due to metal related pathology, alternative solutions to conventional chrome cobalt material have been proposed, for example ceramic component or implant coating. In particular, TiNbN coating has been proposed by most companies thanks to its excellent biological properties. Preclinical studies have showed a high scratch resistance and low coefficient of friction, more resistance to fretting corrosion, reduction of wear, lower ion release rates and low fatigue cycle, as described in the review of Hove. Clinically, cohort of studies of TiN-coated implants showed an overall survival exceeding 90% with a follow-up of 15 to 77 months and good clinical outcomes. No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed. There are few studies that compared TiN-coated implants with the same uncoated version. Thienpont, comparing TiN-coated and uncoated CoCrMo implants, showed similar clinical and radiological outcomes at short-term follow up in both patients groups .
Read more
Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesn't not affect the performance of the device if compared with the same uncoated version.
The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component, coated version.
- Conditions
- Total Knee Arthroplasty
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
preoperative and at 6 months and 1 year follow-up after the surgery the patients will take a blood sample
| Study group | Role | What they receive |
|---|---|---|
| Ion released group | First 30 patients will be assessed for metalic ion released by blood sample. the patients will be monitored until 10 years follow-up for long term performance of the device Receives: Diagnostic Test: blood sample | |
| Other group | The remaining 125 patients will be not assessed for metalic ion released; they will be monitored until 10 years follow-up for long term performance of the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term performance
Device survival will be assessed by Kaplan Maier curve
Measured: 10 years
Secondary outcomes (6)
Clinical performance
Clinical performance will be assessed through the NEW KSS score collected during preoperative and follow-up visits. The score is divided in subscale: objective (0-75), Symptoms (0-25), Satisfaction (0-40), Expectation (0-15), Functional Activities (0-30), high scores indicating good outcomes.
Measured: 6 months, 1, 5 and 10 years after surgery
Radiological performance
standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits
Measured: (1, 5 and 10 years after surgery
Retropatellar pain
Kujala score collected during preoperative visit and follow-up visit. Each scale ranges from 0 to 100 with high scores indicating good outcomes.
Measured: 6 months and 1, 5 and 10 years after surgery
Ion release rate
blood level of ions Co, Cr and Ni in a subgroup of 30 patients
Measured: preoperative, 6 months and 1 year visits
Activity level after surgery
UCLA Activity score collected during preoperative visit and follow-up visit. 1-10 scale with 1 less active, to 10 more active.
Measured: 6 months and 1year after surgery
Rate of complications
collection of all adverse events occurred
Measured: up to 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start5 Feb 2020
- Primary completion5 Feb 2033 (estimated)
- Study completion5 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801654
- Sponsor's protocol ID
- P.02.01.427
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04801654
- Acronym / sponsor ID
- P.02.01.427
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 5 Feb 2033 (estimated)
- Study completion
- 5 Dec 2033 (estimated)
- First posted
- 17 Mar 2021 (actual)
- 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.
Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray.
Recently there has been particular attention on the component material; traditionally femoral components are made of cobalt alloys while tibial baseplates are made, in the great majority of cases, of metallic materials, but also polyethylene versions are available. There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report, making up for 5.9% of all revisions. The wording was subsequently changed from "metal sensitivity" to "metal related pathology" in the 2014 report with 0.5% of all revision total hip arthroplasties (THA) associated with this term. The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 1.3% of revisions in 2012 and in 2014, 1.8% of revision TKAs attributed to "metal related pathology" . The overall revision rate was 3.45% after 10 years in 396.472 TKAs, suggesting a revision rate of 0.06-0.32% secondary to metal or cement allergies. Up to today there is no question that metallic implants may generate wear debris that cause local reactions. This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process. Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction. To prevent issues arising due to metal related pathology, alternative solutions to conventional chrome cobalt material have been proposed, for example ceramic component or implant coating. In particular, TiNbN coating has been proposed by most companies thanks to its excellent biological properties. Preclinical studies have showed a high scratch resistance and low coefficient of friction, more resistance to fretting corrosion, reduction of wear, lower ion release rates and low fatigue cycle, as described in the review of Hove. Clinically, cohort of studies of TiN-coated implants showed an overall survival exceeding 90% with a follow-up of 15 to 77 months and good clinical outcomes. No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed. There are few studies that compared TiN-coated implants with the same uncoated version. Thienpont, comparing TiN-coated and uncoated CoCrMo implants, showed similar clinical and radiological outcomes at short-term follow up in both patients groups .
Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesn't not affect the performance of the device if compared with the same uncoated version.
The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component, coated version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ion released group | – | Diagnostic Test: blood sampleFirst 30 patients will be assessed for metalic ion released by blood sample. the patients will be monitored until 10 years follow-up for long term performance of the device |
| Other group | – | –The remaining 125 patients will be not assessed for metalic ion released; they will be monitored until 10 years follow-up for long term performance of the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size calculation has been performed according to one proportion test comparing expected survival at 10 year of 96.3%[5] with the bench mark value defined by ODEP Panel for a total knee arthroplasty at 10 yrs of 90%. With a significance level of 5% and a power of 80%, 141 patients are necessary to show a non-inferiority test. Considering a lost to follow-up rate of 10%, 155 patients will be recruited. B. Bordini, C. Ancarani, and D. A. Fitch, "Long-term survivorship of a medial-pivot total knee system compared with other cemented designs in an arthroplasty registry," Journal of orthopaedic surgery and research, vol. 11, no. 1, p. 44, 2016
Key inclusion criteria (3 listed)
- Those older than 18 years old at the surgery time
- those suitable to undergo to a primary total knee arthroplasty for whom the GMK Sphere TiNb coated device will be implanted (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery
Key exclusion criteria (5 listed)
- Those patients with metal implants containing Co, Cr and / or Ni
- Those patients who have had environmental or occupational exposure to toxic metals such as Co, Cr and / or Ni (solvents, industrial paints, welders)
- Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups
- Those unable to give their consent to participate in the study or who do not want to participate
- Any condition not mentioned in inclusion criteria.
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 |
|---|---|---|
| blood samplepreoperative and at 6 months and 1 year follow-up after the surgery the patients will take a blood sample | Diagnostic test | Ion released group |
Primary outcome
Long term performance
Time frame: 10 years
Device survival will be assessed by Kaplan Maier curve
6 secondary outcomes
Clinical performance
Time frame: 6 months, 1, 5 and 10 years after surgery
Radiological performance
Time frame: (1, 5 and 10 years after surgery
Retropatellar pain
Time frame: 6 months and 1, 5 and 10 years after surgery
Ion release rate
Time frame: preoperative, 6 months and 1 year visits
Activity level after surgery
Time frame: 6 months and 1year after surgery
Rate of complications
Time frame: up to 10 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site in Italy.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franco Parente, Dr (+390248785210, franco.parente@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term performance (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 1 May 2024.