Monitoring the performance of the GMK SpheriKA knee prosthesis

Is this trial a fit for you?

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 aims to collect clinical and radiological data to evaluate the performance of the GMK SpheriKA knee prosthesis, which is implanted using a kinematic alignment technique. Participants will be monitored postoperatively to assess their recovery and the effectiveness of the prosthesis. The study will involve patients who are undergoing primary total knee replacement and will require their compliance with follow-up evaluations and weight-bearing restrictions.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

* 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.

Where it's running

• Centre de l'Arthrose
  Mérignac, France Recruiting
• Clinique de l'Union
  Saint-Jean, France Recruiting
• Humanitas Castelli
  Bergamo, Italy Recruiting
• Gelenkzentrum Winterthur
  Winterthur, Switzerland Recruiting

Study contacts

• Study coordinator: Arianna Girardi
• Email: girardi@medacta.ch
• Phone: +41 91 696 60 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.