G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

NCT04754087 | Recruiting FDA Device

• 1 other identifier: CMG2019-32H
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 11

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 instrumentation in primary and revision total hip arthroplasty.

Conditions

Total Hip Arthroplasty; Degenerative Joint Disease of Hip; Avascular Necrosis of Hip; Rheumatoid Arthritis of Hip; Osteoarthritis, Hip; Osteoarthritis of Hip; Fractures, Hip; Fracture of Hip

Outcome Measures

Primary Outcomes (2)

• Survival of the study device (liner); whether or not it is still implanted in the subject

  Survivorship will be based on revision or intended revision of the study device (liner).

  At 10 years

• Adverse Event (safety)

  Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.

  At 10 years

Secondary Outcomes (4)

• Pain and Function using Modified Harris Hip Score

  At 10 years

• Pain and Function using Oxford Hip Score

  At 10 years

• Patient Quality of Life using EQ-5D-5L Descriptive System

  At 10 years

• Patient Quality of Life using EQ-5D-5L EQ visual analogue scale

  At 10 years

Study Arms (1)

G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners

OTHER

Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.

Device: Vivacit-E and Longevity (HXLPE) Liners

Interventions

Vivacit-E and Longevity (HXLPE) Liners DEVICE

This is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner.

G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (11)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

ACTIVE NOT RECRUITING

South Bend Orthopaedics

South Bend, Indiana, 46635, United States

ACTIVE NOT RECRUITING

Duke University Medical Center

Durham, North Carolina, 27703, United States

ACTIVE NOT RECRUITING

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, 97401, United States

ACTIVE NOT RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

University of Utah Health

Salt Lake City, Utah, 84112, United States

ACTIVE NOT RECRUITING

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

Zuyderland Hospital

Geleen, 6162 BG, Netherlands

ACTIVE NOT RECRUITING

OCON Hengelo

Hengelo, Netherlands

RECRUITING

Skane University Hospital

Lund, 221 85, Sweden

RECRUITING

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

Bournemouth, UK, BH7 7DW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Wendy J Hatcher

CONTACT

574-549-4281; wendy.hatcher@zimmerbiomet.com

Lynsey Boyle

CONTACT

412-552-7111; lynsey.boyle@zimmerbiomet.com

Study Design

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 15, 2021
• Study Start: July 7, 2021
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); NL (2); SE (1); GB (1); US (6)