Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
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).
• 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