This clinical study is initiated in October 2021 to enroll 14 patients at select medical centers in the Netherlands. The study is full and can no longer accept new participants. The clinical study is approved by the Dutch government (Dutch Health and Youth Care Inspectorate) and Medical Research Ethics Committee.
CAUTION: Artimis® has not yet been approved by regulatory authorities for commercial sale and may only be used in a clinical study. Moreover, by contacting a participating hospital for an appointment you show your interest in participating in the AIR2 study. Other factors may exclude you from participation; only the orthopaedic surgeon who performs the examination will determine your final suitability. The AIR2 study is registered in a clinical study database at Dutch TrialRegister under number NL9805.
The Artimis® meniscus prosthesis is an anatomically shaped, non-biodegradable polymer implant designed to mimic the function of the natural medial meniscus by functioning as a shock absorber within the knee joint. The Artimis® meniscus prosthesis is implanted by an arthroscopic procedure with a specific surgical instrument set to determine correct meniscus prosthesis size and facilitate proper placement of the meniscus prosthesis.
This procedure is intended for people between 18-70 years of age with persistent knee pain in the medial compartment, who underwent a meniscectomy more than 6 months ago. In addition, patients have limited cartilage damage (less than grade IV modified Outerbridge scale) and a nearly straight leg axis. For a complete set of inclusion/exclusion criteria clinical study (AIR study), see the study at the Dutch TrialRegister under number NL9805 The trial is also registered at www.ClinicalTrials.gov under number NCT05297175
As Clinical Field Director, she is a reliable link towards the clinics as well as the social link in our innovative machine.
More about José Lugies