Z1 Hip System: Post-Market Clinical Follow Up Study
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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).
Sponsor: Zimmer Biomet
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Charlotte
Portland
Source: ClinicalTrials.gov · NCT07104279 · last updated 2025-11-10