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NCT04754087 | RECRUITING | Total Hip Arthroplasty

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

Zimmer Biomet

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.

Condition or disease

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

Intervention/treatment

Vivacit-E and Longevity (HXLPE) Liners

Phase

NA

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. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
Actual Study Start Date : 2021-07-07
Estimated Primary Completion Date : 2033-12-31
Estimated Study Completion Date : 2033-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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.
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

Location Details

NCT04754087

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, Colorado

Colorado Joint Replacement

Denver, Colorado, United States, 80210

ACTIVE NOT RECRUITING

United States, Indiana

South Bend Orthopaedics

South Bend, Indiana, United States, 46635

ACTIVE NOT RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27703

ACTIVE NOT RECRUITING

United States, Oregon

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, United States, 97401

ACTIVE NOT RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Utah

University of Utah Health

Salt Lake City, Utah, United States, 84112

RECRUITING

Denmark,

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

ACTIVE NOT RECRUITING

Netherlands,

Zuyderland Hospital

Borrowed, Netherlands, 6162 BG

RECRUITING

Netherlands,

OCON Hengelo

Hengelo, Netherlands,

RECRUITING

Sweden,

Skane University Hospital

Lund, Sweden, 221 85

RECRUITING

United Kingdom, UK

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

Bournemouth, UK, United Kingdom, Bah Haddou