Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
Zimmer Biomet
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-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).
Description
Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relief pain and debilitating symptoms. A femoral stem component is used in conjunction with a femoral head component for the replacement of the proximal femur in total hip or hemi hip arthroplasty. THA now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications include osteoarthritis, rheumatoid arthritis, avascular necrosis (A…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 lea…
Interventions
- DeviceZ1 Femoral Hip System
Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
Locations (2)
- OrthoCarolina/OrthoCarolina Research InstituteCharlotte, North Carolina
- Orthopedic & Fracture SpecialistsPortland, Oregon