Informations générales (source: ClinicalTrials.gov)
Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
Observational
Medacta International SA (Voir sur ClinicalTrials)
juillet 2022
mai 2035
29 juin 2024
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre de l'Arthrose - Mérignac - France | Charles RIVIERE | Contact (sur clinicalTrials) | |||
| Clinique de l'Union - 31240 - Saint-Jean - France | David BENZAQUEN, Dr. | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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).
- Patients with intact collateral ligaments.
- 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).
- Patients with intact collateral ligaments.
- 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.
- Patients with neuromuscular or neurosensory deficiency, which would limit the
ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone
deterioration.
- Patients that are immunologically compromised or receiving chronic steroids (> 30
days).
- Patients whose bone stock is compromised due to disease or infection, unable to
provide adequate support and/or fixation to the prosthesis.
- Patients with an active or suspected latent infection in or surrounding the knee
joint.
- Pregnant or breastfeeding women.