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

Sponsor
AgNovos Healthcare, LLC
Study ID
NCT07594639
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • AGN1 LOEP — DEVICE
    Patients treated with AGN1 LOEP

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
305 participants (estimated)

Primary Outcome Measure

Incidence of fragility fractures of AGN1 LOEP treated hip [ Time Frame: Through study completion, an average of 6 months. ]

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