Z1 Hip System post-market follow-up
Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
This tests whether the Z1 Femoral Hip System is safe and helpful for adults having total or hemi hip replacement for osteoarthritis, femoral head/neck fractures, or avascular necrosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT07104279 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) who are candidates for primary total hip arthroplasty or hemiarthroplasty for osteoarthritis, acute femoral head/neck fracture, or avascular necrosis and who can provide informed consent and comply with follow-up are ideal.
Not a fit: Patients requiring revision arthroplasty, with active local or systemic infections, or with severe muscular, neural, or vascular diseases endangering the limb are excluded and unlikely to benefit from this enrollment.
Why it matters
Potential benefit: If successful, this could confirm the Z1 system's early to mid-term safety and functional benefits, giving patients and surgeons more confidence in its use.
How similar studies have performed: Similar post-market and clinical studies of femoral hip systems have generally shown acceptable early to mid-term implant survival and improvements in patient-reported outcomes, though device-specific results vary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlotte, North Carolina and 1 other locations
- OrthoCarolina/OrthoCarolina Research Institute — Charlotte, North Carolina, United States (Recruiting)
- Orthopedic & Fracture Specialists — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Taylor Rowe
- Email: Taylor.Rowe@zimmerbiomet.com
- Phone: 980-259-2813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.