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Completed NCT03226808

Vivacit-E Post-market Follow-up Study

Conditions: Osteoarthritis, Avascular Necrosis of Bone of Hip, Post-traumatic; Arthrosis, Congenital Hip Dysplasia

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 245
Sponsor: Zimmer Biomet

Location: Denver Hip and Knee, Inc. Parker Colorado

Summary

The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.

Eligibility Criteria

Inclusion Criteria: * Patient is 18 to 60 years of age, inclusive. * Patient is skeletally mature. * Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following: * Osteoarthritis * Avascular necrosis (AVN) * Post-traumatic arthritis * Congenital hip dysplasia * Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s). * Patient is willing and able to provide written informed consent. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the IRB/EC approved informed consent. Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s). * Inflammatory Arthritis * Rheumatoid Arthritis * The patient is: * a prisoner mentally incompetent or unable to understand what participation in the study entails a known alcohol or drug abuser * anticipated to be non-compliant * The patient has an acute, chronic, or systemic infection(s). * The patient has total or partial absence of the muscular or ligamentous apparatus. * The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation. * The patient has osteoradionecrosis. * The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible. * The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation. * The patient is skeletally immature. * The patient has any concomitant disease that can jeopardize the functioning and the success of the implant. * The patient is known to be pregnant. * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03226808). StuddyBuddy aggregates publicly available trial information.