Status:
RECRUITING
GMK Sphere TiNb Total Knee Arthroplasty PMS Study
Lead Sponsor:
Medacta International SA
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Brief 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 articul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 5 2033
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04801654
Start Date
February 5 2020
End Date
December 5 2033
Last Update
May 1 2024
Active Locations (1)
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1
IRCCS Istituto Ortopedico Galeazzi di Milano Sede di via Monreale18 (Istituto Clinico San Siro)
Milan, MI, Italy, 20148