Evaluation of a new knee implant material in total knee replacement surgery
Official title: A Monocentric, Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty
Run by Medacta International SA · NCT04801654 · Data updated 2026-11-12
This study is testing a new knee implant material in people getting knee replacement surgery to see how it works and if it causes any reactions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 155 (estimated) |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | February 5, 2020 |
| Main results expected | February 5, 2033 |
| Study ends | December 5, 2033 |
| Registry record updated | May 1, 2024 |
| Trial ID | NCT04801654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are scheduled for primary total knee arthroplasty with the GMK Sphere TiNb device.
✕Probably not a fit
Patients with existing metal implants or those with a history of exposure to toxic metals may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients undergoing total knee arthroplasty (TKA) using the GMK Sphere TiNb coated device. It aims to assess the outcomes and potential metal-related pathologies associated with traditional knee implant materials. Participants will provide blood samples to evaluate any hypersensitivity or adverse reactions to the implant materials. The study will include patients over 18 years old who are suitable for primary TKA and willing to give informed consent.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients receiving total knee arthroplasty.
How similar studies have gone: While there have been studies on metal sensitivity in hip arthroplasties, this specific approach to knee arthroplasty with TiNb coatings is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
-
IRCCS Istituto Ortopedico Galeazzi di Milano Sede di via Monreale18 (Istituto Clinico San Siro)
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Franco Parente, Dr
- Email: franco.parente@grupposandonato.it
- Phone: +390248785210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.