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- 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

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

Locations4 sites

Find trials near these locations

Browse More Trials