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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05659329). StuddyBuddy aggregates publicly available trial information.