MDR-G7 Freedom Constrained Liners
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|ClinicalTrials.gov Identifier: NCT04093739|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment|
|Hip Osteoarthritis Hip Disease Hip Fractures Hip Injuries||Device: G7 Freedom Constrained Liners|
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|
|Estimated Enrollment :||101 participants|
|Official Title:||Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the G7 Freedom Constrained Liners in Primary and Revision Total Hip Arthroplasty|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 30, 2024|
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.
- Device Safety assessed through the frequency and incidence of revisions, complications and adverse events [ Time Frame: 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.
- Device Performance and Benefits evaluated through the Oxford Hip Score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093739
|Contact: Madison K Oakesfirstname.lastname@example.org|
|Contact: Paula Phillipsemail@example.com|
|Study Director:||Kacy Arnold||Zimmer Biomet|