G7 Freedom Constrained Vivacit-E Liners

NCT05587244 | Enrolling By Invitation FDA Device

• 1 other identifier: CMG2021-36H
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survival of the study device

  Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.

  10 years

Secondary Outcomes (10)

• Incidence of treatment-emergent Adverse Events (safety)

  10 years

• Pain and Functional Performance - Modified Harris Hip Score

  10 years

• Pain and Functional Performance - Oxford Hip Score

  10 years

• Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)

  10 Years

• Radiographic Performance evaluating radiolucency at 5 years follow-up

  5 Years

Study Arms (1)

Total Hip Arthroplasty Treatment Group

EXPERIMENTAL

This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.

Device: Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners

Interventions

Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners DEVICE

Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners

Total Hip Arthroplasty Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Florida Board of Trustees

Gainesville, Florida, 32611, United States

Location

Jersey City Medical Center, Inc

Livingston, New Jersey, 07039, United States

Location

The Ohio State University

Columbus, Ohio, 43201, United States

Location

TOA Research Foundation

Knoxville, Tennessee, 37923, United States

Location

The University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Fractures, Ununited; Hip Fractures; Femoral Neck Fractures; Osteonecrosis; Hip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Fractures, Bone; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, two cohort study

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 20, 2022
• Study Start: May 8, 2023
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2038
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)