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MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

NCT ID: NCT04093739

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-30

Study Completion Date

2029-12-31

Brief Summary

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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

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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).

Conditions

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Hip Osteoarthritis Hip Disease Hip Fractures Hip Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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G7 Freedom Constrained Liners

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

G7 Freedom Constrained Liners

Intervention Type DEVICE

Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease.

Interventions

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G7 Freedom Constrained Liners

Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Osborn

Role: STUDY_DIRECTOR

Zimmer Biomet

Other Identifiers

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MDRG2017-89MS-53H

Identifier Type: -

Identifier Source: org_study_id