Z1 Hip System: Post-Market Clinical Follow Up Study

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

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 bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible
* Total or partial absence of the muscular or ligamentous apparatus
* Any concomitant diseases that can jeopardize the functioning and the success of the implant
* Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)
* Local bone tumors and/or cysts
* Patient has any condition that would, in the Investigator's opinion, place the patient at undue risk or interfere with the study
* Any vulnerable subject:

  * a prisoner
  * a patient known to be pregnant
  * mentally incompetent or unable to understand what participation in the study entails
  * a known substance abuser

Conditions4

Locations2 sites

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