Status:
RECRUITING
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Total Hip Arthroplasty
Degenerative Joint Disease of Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 instru...
Detailed Description
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. T...
Eligibility Criteria
Inclusion
- Patient must be a legal adult who has reached full skeletal maturity.
- Patient must be treated for one of the following indications:
- 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 treatment or devices have failed
- Patient must be able and willing to complete the protocol required follow-up visits.
- Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.
Exclusion
- Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
- Patient has a metabolic disorder that may impair bone formation.
- Patient has osteomalacia.
- Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
- Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient is pregnant.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04754087
Start Date
July 7 2021
End Date
December 31 2033
Last Update
June 18 2025
Active Locations (11)
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1
Colorado Joint Replacement
Denver, Colorado, United States, 80210
2
South Bend Orthopaedics
South Bend, Indiana, United States, 46635
3
Duke University Medical Center
Durham, North Carolina, United States, 27703
4
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States, 97401