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

NCT07594639 | Not Yet Recruiting

• 1 other identifier: AGN-CIP-304
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Bone mineral density; Femoral strength; Hip fracture; Local osteo-enhancement procedure; LOEP; Proximal femur; Osteogenesis Imperfecta; OI; Hypophosphatasia; HPP

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

AGN1 LOEP DEVICE

Patients treated with AGN1 LOEP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects whose AGN1 LOEP treatment was performed outside of a prior AgNovos sponsored clinical study are considered for this study. The study anticipates enrolling up to 305 subjects. The final sample size may be smaller depending on willingness to participate or subject availability

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (1)

Vitaz

Sint-Niklaas, Belgium

Location

MeSH Terms

Conditions

Osteoporosis; Hip Fractures; Osteogenesis Imperfecta; Hypophosphatasia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)