The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedacta International SA
About this trial
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Eligibility criteria
Qualifiers
Patients willing to sign the informed consent.
Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
Patients 18 - 80 years of age at the time of surgery.
Patients requiring a primary total knee replacement (on label use).
Disqualifiers
Patients with inflammatory arthritis.
Morbidly obese patients, with a body mass index (BMI) > 40.
Patients with a history of total or unicompartmental reconstruction of the affected joint.
Patients that have had a high tibial osteotomy or femoral osteotomy.
Trial design
Treatments tested in this trial
- GMK SpheriKA
Treatment groups
No treatment groups listed
Locations
4France
Centre de l'Arthrose Mérignac France
Clinique de l'Union31240, Saint-Jean France
Italy
Humanitas Castelli Bergamo Italy
Switzerland
Gelenkzentrum Winterthur Winterthur Switzerland
Sponsors and collaborators
Medacta International SA
Lead sponsor
Source ClinicalTrials.gov