Clinical trial NCT04754087: G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Survival of the study device (liner); whether or not it is still implanted in the subject
timeFrame: At 10 years
measure: Adverse Event (safety)
timeFrame: At 10 years
Secondary outcomes:
measure: Pain and Function using Modified Harris Hip Score
timeFrame: At 10 years
measure: Pain and Function using Oxford Hip Score
timeFrame: At 10 years
measure: Patient Quality of Life using EQ-5D-5L Descriptive System
timeFrame: At 10 years
measure: Patient Quality of Life using EQ-5D-5L EQ visual analogue scale
timeFrame: At 10 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: South Bend
country: United States
facility: South Bend Orthopaedics
state: Indiana
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Eugene
country: United States
facility: Slocum Center for Orthopedics & Sports Medicine
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
city: Geleen
country: Netherlands
facility: Zuyderland Hospital
city: Hengelo
country: Netherlands
facility: OCON Hengelo
city: Lund
country: Sweden
facility: Skane University Hospital
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
state: UK
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: