GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
ConditionOsteoporosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAgNovos Healthcare, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
AGN1 LOEP
DevicePatients treated with AGN1 LOEP
Treatment groups
No treatment groups listed
Trial outcomes
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 contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: