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

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754087
• Other study ID #: CMG2019-32H
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: December 31, 2033

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: Wendy J Hatcher
• Phone: 574-549-4281
• Email: wendy.hatcher[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Degenerative Joint Disease of Hip
• Fracture of Hip
• Fractures, Bone
• Fractures, Hip
• Hip Fractures
• Joint Diseases
• Necrosis
• Osteoarthritis
• Osteoarthritis of Hip
• Osteoarthritis, Hip
• Rheumatoid Arthritis of Hip
• Total Hip Arthroplasty

Intervention

Device:
• Vivacit-E and Longevity (HXLPE) Liners
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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre
Netherlands	Zuyderland Hospital	Geleen
Netherlands	OCON Hengelo	Hengelo
Sweden	Skane University Hospital	Lund
United Kingdom	The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital	Bournemouth	UK
United States	Colorado Joint Replacement	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Slocum Center for Orthopedics & Sports Medicine	Eugene	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Utah Health	Salt Lake City	Utah
United States	South Bend Orthopaedics	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Denmark,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain and Function using Modified Harris Hip Score	Pain and function will be measured using the Modified Harris Hip Score self assessment. The overall score runs from 0-100 with 100 representing the best outcome.	At 10 years
Secondary	Pain and Function using Oxford Hip Score	Pain and function will be measured using the Oxford Hip Score self assessment. The overall score runs from 0-48 with 48 representing the best outcome.	At 10 years
Secondary	Patient Quality of Life using EQ-5D-5L Descriptive System	Perceived qualify of life will be measured using the EQ-5D-5L Descriptive System - comprises mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each question in this section has an overall score of 1-5 with 1 representing the best health.	At 10 years
Secondary	Patient Quality of Life using EQ-5D-5L EQ visual analogue scale	Perceived qualify of life will be measured using the EQ visual analogue scale (EQ VAS) - records the respondent's self-rated health on a vertical, visual analogue scale. This section has an overall score of 0-100 with 100 representing the best health.	At 10 years