Actively Recruiting
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Led by Zimmer Biomet · Updated on 2025-06-18
300
Participants Needed
11
Research Sites
651 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.
CONDITIONS
Official Title
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be a legal adult who has reached full skeletal maturity.
- Patient must be treated for one of the following: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement unmanageable by other techniques, revision procedures where other treatments or devices have failed.
- Patient must be able and willing to complete the required follow-up visits.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
You will not qualify if you...
- Patient has osteoporosis that may limit the ability to support total hip arthroplasty with the study device.
- Patient has a metabolic disorder impairing bone formation.
- Patient has osteomalacia.
- Patient has distant infections that may spread to the implant site or active infection, sepsis, or osteomyelitis.
- Patient has rapid joint destruction, marked bone loss, or bone resorption visible on X-rays.
- Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease.
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is uncooperative or has neurologic disorders preventing following directions.
- Patient is pregnant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Colorado Joint Replacement
Denver, Colorado, United States, 80210
Active, Not Recruiting
2
South Bend Orthopaedics
South Bend, Indiana, United States, 46635
Active, Not Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27703
Active, Not Recruiting
4
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States, 97401
Active, Not Recruiting
5
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
6
University of Utah Health
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
7
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
8
Zuyderland Hospital
Geleen, Netherlands, 6162 BG
Active, Not Recruiting
9
OCON Hengelo
Hengelo, Netherlands
Actively Recruiting
10
Skane University Hospital
Lund, Sweden, 221 85
Actively Recruiting
11
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
Bournemouth, UK, United Kingdom, BH7 7DW
Actively Recruiting
Research Team
W
Wendy J Hatcher
CONTACT
L
Lynsey Boyle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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