Z1 Hip System: Post-Market Clinical Follow Up Study

Recruiting now

Conditions studied: Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck, Avascular Necrosis of the Femoral Head

In brief

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).

Key facts

Study ID

NCT07104279

Run by

Zimmer Biomet

People needed

150

Starts

2025-10-13

Expected to finish

2031-08-01

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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 it is running

• OrthoCarolina/OrthoCarolina Research Institute — Charlotte, North Carolina, United States (enrolling)
• Orthopedic & Fracture Specialists — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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