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NCT Number: NCT07594639

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Developmental Bone Diseases, Metabolic Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Femoral Fractures Fractures, Bone Genetic Diseases, Inborn Hip Fractures Hip Injuries Hypophosphatasia Leg Injuries Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteochondrodysplasias Osteogenesis Imperfecta Skin and Connective Tissue Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.
  • Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.

Exclusion criteria

-The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.

Treatment and study plan

AGN1 LOEP

Device

Patients treated with AGN1 LOEP

Primary outcomes

  1. Incidence of fragility fractures of AGN1 LOEP treated hip

    Time frame: Through study completion, an average of 6 months.

  2. 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

    Time frame: Through study completion, an average of 6 months.

Sponsors and collaborators

Lead sponsor

AgNovos Healthcare, LLC

Industry

Registry information

Official study title

Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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