Osteoporosis
Conditions
Keywords
Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur
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.
Interventions
None listed
Sponsors
AgNovos Healthcare, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject satisfaction | 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. |
| Subject Safety | 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. |
Countries
Belgium
Outcome results
None listed