G7 Freedom Constrained Vivacit-E Liners

Enrolling by invitation · Not applicable

Conditions studied: Osteoarthritis, Hip, Rheumatoid Arthritis, Non-Union Fracture, Trochanteric Fractures, Femoral Neck Fractures, Avascular Necrosis, Dislocation, Hip

In brief

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Key facts

Study ID

NCT05587244

Run by

Zimmer Biomet

People needed

202

Starts

2023-05-08

Expected to finish

2038-12-01

Last updated by the study team

2025-10-20

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 unilateral 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
• High risk for dislocation
• Undergoing revision hip arthroplasty
• Correction of functional deformity
• In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• 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, has participated in the Informed Consent process and is willing and able to sign an IRB 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 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 might jeopardize the outcome of the surgery.
• In the opinion of the investigator, 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 the 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

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• University of Florida Board of Trustees — Gainesville, Florida, United States
• Jersey City Medical Center, Inc — Livingston, New Jersey, United States
• The Ohio State University — Columbus, Ohio, United States
• TOA Research Foundation — Knoxville, Tennessee, United States
• The University of Texas Health Science Center of Houston — Houston, Texas, United States
• Medical City Plano — Plano, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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