Trials / Withdrawn
WithdrawnNCT04093739
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)
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | G7 Freedom Constrained Liners | Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease. |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
- First posted
- 2019-09-18
- Last updated
- 2023-12-13
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04093739. Inclusion in this directory is not an endorsement.