G7 With Vivacit-E and Longevity Post-market Follow-up Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04754087

Collaborator

(none)

300

Enrollment

Locations

Arm

149.8

Anticipated Duration (Months)

27.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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	Device: Vivacit-E and Longevity (HXLPE) Liners	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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 :

Jul 7, 2021

Anticipated Primary Completion Date :

Dec 31, 2033

Anticipated Study Completion Date :

Dec 31, 2033

Arms and Interventions

Arm	Intervention/Treatment
Other: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners 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 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.

Arm

Intervention/Treatment

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

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

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.

Outcome Measures

Primary Outcome Measures

Survival of the study device (liner); whether or not it is still implanted in the subject [At 10 years]
Survivorship will be based on revision or intended revision of the study device (liner).
Adverse Event (safety) [At 10 years]
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.

Secondary Outcome Measures

Pain and Function using Modified Harris Hip Score [At 10 years]
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.
Pain and Function using Oxford Hip Score [At 10 years]
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.
Patient Quality of Life using EQ-5D-5L Descriptive System [At 10 years]
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.
Patient Quality of Life using EQ-5D-5L EQ visual analogue scale [At 10 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Joint Replacement	Denver	Colorado	United States	80210
2	South Bend Orthopaedics	South Bend	Indiana	United States	46635
3	Duke University Medical Center	Durham	North Carolina	United States	27703
4	Slocum Center for Orthopedics & Sports Medicine	Eugene	Oregon	United States	97401
5	Oregon Health and Science University	Portland	Oregon	United States	97239
6	University of Utah Health	Salt Lake City	Utah	United States	84112
7	Copenhagen University Hospital Hvidovre	Hvidovre		Denmark	2650
8	Zuyderland Hospital	Geleen		Netherlands	6162 BG
9	OCON Hengelo	Hengelo		Netherlands
10	Skane University Hospital	Lund		Sweden	221 85
11	The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital	Bournemouth	UK	United Kingdom	BH7 7DW