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Clinical Trial

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

NCT: NCT07594639 · NOT_YET_RECRUITING

NCT IDNCT07594639
StatusNOT_YET_RECRUITING
Start Date2026-06-01
Completion2026-09-30

Brief 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.

Frequently Asked Questions

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

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP) is a clinical trial registered under NCT07594639. Current status: NOT_YET_RECRUITING.

What is the status of NCT07594639?

The current status of NCT07594639 (GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)) is: NOT_YET_RECRUITING.

When did GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP) start?

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP) started on 2026-06-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.