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