GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

NCT05966974 | Completed

• 1 other identifier: AGN-CIP-302
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. 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 outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.

Conditions

Osteoporosis

Keywords

Bone mineral density; Femoral strength; Hip fracture; Local osteo-enhancement procedure; LOEP; Proximal femur

Outcome Measures

Primary Outcomes (3)

• Subject satisfaction

  Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.

  Through study completion, an average of 1.1 years

• Subject Safety

  Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.

  During the procedure

• Subject Safety

  Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.

  Through study completion, an average of 1.1 years

Study Arms (1)

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

Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.

You may qualify if:

• Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
• Subject has willingness to participate in the study.
• Subject can give written informed consent to allow for data collection.

You may not qualify if:

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

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (1)

Vitaz

Sint-Niklaas, 9100, Belgium

Location

MeSH Terms

Conditions

Osteoporosis; Hip Fractures

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

Study Design

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

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: August 1, 2023
• Study Start: December 15, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)