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MDR-G7 Freedom Constrained Liners

2019-09-24 05:27:39 | BioPortfolio

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.

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 Design

Conditions

Hip Osteoarthritis

Intervention

G7 Freedom Constrained Liners

Status

Not yet recruiting

Source

Zimmer Biomet

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-24T05:27:39-0400

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Medical and Biotech [MESH] Definitions

Absorbent pads designed to be worn as underpants or pants liners by adults.

Absorbent pads used for URINARY INCONTINENCE and usually worn as underpants or pants liners by the ELDERLY.

Freedom from activity.

The rights of individuals to act and make decisions without external constraints.

The attitude that grants freedom of expression and activity to another individual, but not necessarily with sanction or approval.

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Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

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Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. Osteo...

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