Actively Recruiting
Z1 Hip System: Post-Market Clinical Follow Up Study
Led by Zimmer Biomet · Updated on 2025-11-10
150
Participants Needed
2
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Z1 Hip System: Post-Market Clinical Follow Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old and skeletally mature
- Patient is physically and mentally willing and able to comply with the protocol and scheduled evaluations
- Patient or legally authorized representative is willing and able to provide informed consent
- Patient qualifies for primary total hip or hemi-arthroplasty based on physical exam and history including at least one of the following: advanced joint wear due to degenerative, post-traumatic, or rheumatic diseases; acute traumatic fracture of the femoral head or neck; avascular necrosis of the femoral head
You will not qualify if you...
- Revision arthroplasty
- Acute, chronic, local, or systemic infections
- Severe muscular, neural, or vascular diseases endangering the affected limb(s)
- Lack of sufficient bone structure near the joint making implant anchorage unlikely or impossible
- Total or partial absence of muscular or ligamentous apparatus
- Any diseases that may jeopardize implant function or success
- Allergy to implant materials, especially metals like cobalt, chromium, or nickel
- Presence of local bone tumors or cysts
- Any condition placing the patient at undue risk or interfering with the study
- Vulnerable subjects including prisoners, pregnant patients, mentally incompetent individuals, or known substance abusers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
OrthoCarolina/OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
Actively Recruiting
2
Orthopedic & Fracture Specialists
Portland, Oregon, United States, 97225
Actively Recruiting
Research Team
T
Taylor Rowe
CONTACT
L
Lynsey Boyle
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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