MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

Post-market Clinical Follow-up Study of the G7 Freedom Constrained Neutral Liner and G7 Neutral +5mm Liner in Primary and Revision Total Hip Arthroplasty (Implants and Instrumentation)

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

Study Overview

• Status: Withdrawn
• Conditions: Hip Fractures; Hip Injuries; Hip Osteoarthritis; Hip Disease
• Intervention / Treatment: Device: G7 Freedom Constrained Liners

Detailed Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This will include a consecutive series of subjects implanted with the G7 Freedom Constrained Liners in primary and revision total hip arthroplasty according to the approved

Description

Inclusion Criteria:

• Patient must be 18 years of age or older and skeletally mature
• Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
• Noninflammatory degenerative joint disease including:
• Osteoarthritis
• 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
• High risk of dislocation due to:
• History of prior dislocation
• Bone loss
• Joint or soft tissue laxity
• Neuromuscular disease
• Intraoperative instability
• Revision procedures where other treatment or devices have failed

Exclusion Criteria:

• Off-label use
• Infection and/or distant foci of infections which may spread to the implant site
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy or neuromuscular disease
• Patient is known to be pregnant or nursing
• Patient is a prisoner
• Patient is a known alcohol or drug abuser
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Patient is unwilling to sign an informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G7 Freedom Constrained Liners; Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease.	Device: G7 Freedom Constrained Liners; Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events	The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.	Out to five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Performance and Benefits evaluated through the Oxford Hip Score	The OHS is a patient completed 12 question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.	Out to five years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Erin Osborn, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Osteoarthritis; Hip Fractures; Osteoarthritis, Hip; Hip Injuries
• Other Study ID Numbers: MDRG2017-89MS-53H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes