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- and primary total hip arthroplasty.
Cohort 0 The primary endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the 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.
The secondary endpoints are defined by the functional performance and clinical benefits of the study device and are assessed by patient-reported clinical outcomes measures (PROMs)(Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)).
Cohort 1 The primary performance endpoint is the assessment of the HOOS JR, specifically the within-patient change from baseline to 2-years post-op. The mean change from baseline will be compared against a minimal clinically important difference (MCID) of 9.46 points.
The key secondary safety endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the 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.
Exploratory outcomes include:
* EuroQol 5 Dimensions (EQ-5D) * Patient Satisfaction * Radiographic outcomes, where available
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 300 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 Primary Outcome (Cohort 0)
The primary endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the 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. Cohort 1
2 Year Primary Outcome (Cohort 1)
The primary performance endpoint is the assessment of the HOOS JR, specifically the within-patient change from baseline to 2-years post-op. The mean change from baseline will be compared against a minimal clinically important difference (MCID) of 9.46 points.
HOOS Jr
Cohort 0: The functional performance and clinical benefits of the study device will be assessed by a patient-reported clinical outcomes measure (PROM)(HOOS JR).
Survivorship
Cohort 1: The key secondary safety endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the 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. Each secondary endpoint will be followed out to 5 years.
Exploratory Outcome: EuroQol 5 Dimensions (EQ-5D)
Cohort 1: The EQ-5D-5L PROM will be collected preoperatively, 1, 2, and 5 years.
Exploratory Outcome: Patient Satisfaction
Cohort 1: Patient satisfaction will be collected at 6 months, 1, 2, and 5 years
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