MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

Withdrawn

• Conditions: Hip Injuries; Hip Fractures; Hip Osteoarthritis; Hip Disease
• Interventions: Device: G7 Freedom Constrained Liners

• Registration Number: NCT04093739
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Study Start: 2022-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G7 Freedom Constrained Liners	G7 Freedom Constrained Liners	Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease.

Primary Outcome Measures

Name	Time	Method
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events	Out to five years	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.

Secondary Outcome Measures

Name	Time	Method
Device Performance and Benefits evaluated through the Oxford Hip Score	Out to five years	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.