GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)

Condition(s) studied

Investigational drug(s) / intervention(s)

AGN1 LOEP: Patients treated with AGN1 LOEP

Study summary

The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.

Eligibility

Primary outcome measure(s)

• Incidence of fragility fractures of AGN1 LOEP treated hip — Through study completion, an average of 6 months.
• Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device — Through study completion, an average of 6 months.

Trial sites (1)

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