G7 Dual Mobility With Vivacit-E or Longevity PMCF

Enrolling by invitation · Not applicable

Conditions studied: Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis, Dislocation, Hip, Femoral Neck Fractures, Trochanteric Fractures, Revision Surgeries

In brief

This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty

Key facts

Study ID: NCT05548972
Run by: Zimmer Biomet
People needed: 358
Starts: 2023-03-20
Expected to finish: 2037-08-01
Last updated by the study team: 2025-06-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is 18 to 80 years of age, inclusive
Patient is skeletally mature
Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Dislocation risks
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 is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent

You may not qualify if…

Patient is septic, has an active infection or has osteomyelitis at the affected joint
Patient has significant osteoporosis as defined by treating surgeon
Patient has metabolic disorder(s) which may impair bone formation
Patient has osteomalacia
Patient has distant foci of infections which may spread to the implant site
Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs
Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
Patient is undergoing simultaneous bilateral THA
Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which are likely to jeopardize the outcome of the surgery.
Patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
Patient is known to be pregnant
The patient is in a vulnerable population group such as:
a prisoner
a known alcohol or drug abuser
mentally incompetent or unable to understand what participation in this study entails

Where it is running

Bowen Hefley Orthopedics — Little Rock, Arkansas, United States
HCA HealthONE Orthopedic Specialists — Denver, Colorado, United States
Jersey City Medical Center — Jersey City, New Jersey, United States
Hospital for Special Surgery — New York, New York, United States
The Cleveland Clinic — Cleveland, Ohio, United States
Slocum Research & Education Foundation — Eugene, Oregon, United States
UZ Leuven — Leuven, Belgium
Istituto San Siro — Milan, Italy
Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam, South Korea
Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea

Full record on ClinicalTrials.gov

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