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Active Not Recruiting
NCT05659329
Retrospective Simplex High Viscosity (HV) Bone Cement Study
Conditions: Arthritis Knee, Aseptic Loosening
Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Stryker Orthopaedics
Summary
This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:The Patient is age 18 or over at time of study device implantationPatients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on labelPatients who have been followed for at least 24 months postoperativelyExclusion Criteria:Patients who have undergone revision surgeryPatients who have undergone bilateral Knee ArthroplastyPatients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for usePatient has a cementless tibial baseplate.Patient has an active or suspected latent infection in or about the affected knee jointPatient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable riskPatient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g.
> 30 days)Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failurePatient is a prisoner
Source: ClinicalTrials.gov (NCT05659329). StuddyBuddy aggregates publicly available trial information.