Z1 Hip System post-market follow-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational post-market follow-up enrolls adults who receive the Z1 Femoral Hip System during primary total or hemi hip arthroplasty and follows them through at least 2 years after implantation. The primary outcome is implant survival at 2 years, with recording of revisions, complications, and adverse events and documentation of their relation to the implant, instrumentation, or procedure. Secondary outcomes include patient-reported outcome measures to track pain, function, and quality of life over early to mid-term follow-up. Sites include orthopedic centers in Charlotte, NC and Portland, OR, and enrollment is limited to patients who meet the study's inclusion and exclusion criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Mokan Orthopedic Research and Consulting
  Platte City, Missouri, United States Recruiting
• OrthoCarolina/OrthoCarolina Research Institute
  Charlotte, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Orthopedic & Fracture Specialists
  Portland, Oregon, United States Recruiting
• Anderson Orthopaedic/Anderson Orthopaedic Research Institute
  Alexandria, Virginia, United States Recruiting

Study contacts

• Study coordinator: Taylor Rowe
• Email: Taylor.Rowe@zimmerbiomet.com
• Phone: 980-259-2813

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.