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OpenTrials
Completed

NCT Number: NCT05966974

GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitaz

Sint-Niklaas, 9100, Belgium

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 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Subject satisfaction

    Time frame: Through study completion, an average of 1.1 years

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

  2. Subject Safety

    Time frame: During the procedure

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

  3. Subject Safety

    Time frame: Through study completion, an average of 1.1 years

    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.

Sponsors and collaborators

Lead sponsor

AgNovos Healthcare, LLC

Industry

Registry information

Official study title

Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

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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