Condition: Hip Osteoarthritis · Acute Traumatic Fracture of the Femoral Head or Neck · Avascular Necrosis of the Femoral Head · Sponsor: Zimmer Biomet
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).
This description comes directly from the study's public registry record.
Taylor Rowe · 980-259-2813 · Taylor.Rowe@zimmerbiomet.com
Lynsey Boyle · lynsey.boyle@zimmerbiomet.com
Always discuss trial participation with your own doctor first.
| OrthoCarolina/OrthoCarolina Research Institute | Charlotte, North Carolina, United States | Recruiting |
| Orthopedic & Fracture Specialists | Portland, Oregon, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07104279