Z1 Hip System: Post-Market Clinical Follow Up Study

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Zimmer Biomet
Study ID
NCT07104279
Status
Recruiting
Apply to this trial

Conditions

  • Acute Traumatic Fracture of the Femoral Head or Neck
  • Avascular Necrosis of the Femoral Head
  • Hip Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Z1 Femoral Hip System — DEVICE
    Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty

Study Details

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 Dates

Start date
Oct 13, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2031

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Subjects implanted with the Z1 Femoral Hip System

Primary Outcome Measure

2 Year Survivorship [ Time Frame: 2 years post-operative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OrthoCarolina/OrthoCarolina Research InstituteCharlotteNorth Carolina28207
Alexis Ready
[email protected]
704-323-3620
Caleb Michalek
[email protected]
704.323.3698
John Masonis, MD (PRINCIPAL_INVESTIGATOR)
Keith Fehring, MD (SUB_INVESTIGATOR)
Jesse Otero, MD, PhD (SUB_INVESTIGATOR)
Orthopedic & Fracture SpecialistsPortlandOregon97225
Jacquline Shelton
[email protected]
503-214-5209
Elizabeth Lieberman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
OrthoCarolina/OrthoCarolina Research Institute· Charlotte, NCOrthopedic & Fracture Specialists· Portland, OR

Related Studies