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
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases
Revision arthroplasty
Acute, chronic, local, or systemic infection(s)
Severe muscular, neural, or vascular diseases that endanger the limb(s) involved
Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible
The study population should consist of up to 150 subjects implanted with the Z1 Femoral Hip System in hemi or total hip arthroplasty, according to the approved indications. Inclusion and exclusion criteria are based on the indications and contraindications defined in the IFU for the Z1 Femoral Hip System.
Cohort
Other
Z1 Femoral Hip System
DeviceSubjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
2 Year Survivorship
The absence of removal of the study device will be evaluated using Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure.
HOOS JR
The functional performance and clinical benefits of the study device will be assessed by a patient-reported clinical outcomes measure (PROM)(HOOS JR).
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