Z1 Hip System: Post-Market Clinical Follow Up Study
Trial Parameters
Brief Summary
The objectives of this study are to confirm the early to mid-term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty. The primary objective of this post market clinical follow-up (PMCF) study is the assessment of safety by recording and analyzing the survival of the implant system at 2 years post-implantation. Safety will also be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation, and/or procedure should be specified. The secondary objective is the assessment of functional performance and clinical benefits of the Z1 Femoral Hip System demonstrated by recording patient-reported clinical outcomes measures (PROMs).
Eligibility Criteria
Inclusion Criteria: * Patient is at least 18 years old and skeletally mature * Patient is physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol, including all scheduled study evaluations * Patient, or the patient's legally authorized representative, is willing and able to participate in the Informed Consent process and provide their consent * Independent of study participation, patient is a candidate and qualifies for primary total hip or hemi-arthroplasty based on physical exam and medical history including at least one of the following: * Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases * Acute traumatic fracture of the femoral head or neck * Avascular necrosis (AVN) of the femoral head Exclusion Criteria: * Revision arthroplasty * Acute, chronic, local, or systemic infection(s) * Severe muscular, neural, or vascular diseases that endanger the limb(s) involved * Lack of