Osteopenic Women, Proximal Femur Fracture
Conditions
Keywords
LOEP, osteoporosis, femur fracture
Brief summary
To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of Osteoporotic Patients. Performance will be evaluated via medical history evaluation, X-ray, DXA, CT and mobility testing. The study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. In this manner, it may be possible to determine the rate of change in BMD following the treatment; thereby allowing prediction of the total benefit period. In addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.
Detailed description
This observational single arm study will be broken into two parts: 1. A retrospective component which will evaluate the original FRAX score along with any events or medications received after the end of the original study. 2. A prospective component which will evaluate longer term outcomes following the use of the AGN1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging. In the original study, subjects completed a twenty-four (24) month follow-up visit after receiving a unilateral hip injection with the device. The contralateral hip acted as the control. The purpose of the study was to determine the safety of the injection as well as the initial improvement in femoral bone density in a twenty-four (24) month period. In this follow-up study the subjects, after signing the informed consent form, will complete a short medical history (focused on their osteoporosis management) and a mobility test. Subjects will also undergo a DXA, X-ray and CT scans of both hips.
Interventions
None listed
Sponsors
AgNovos Healthcare, LLC
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
56 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* participated in the original study and signed the consent form * received treatment with AGN1 Femoral LOEP * completed the study.
Exclusion criteria
* There is no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density | through study completion, an average of 30 days | Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Interview | through study completion, an average of 30 days | All osteoporosis related events (as defined by the Investigator) from the twenty-four (24) month follow-up visit to current point-in-time including fragility fractures, changes in mobility and medication reactions. |
| FRAX Index Risk Assessment | through study completion, an average of 30 days | Comparative calculation of a FRAX index for hip fracture risk based on BMD data from the treatment and contralateral hip using pre-procedure data compared to current point-in-time. |
Outcome results
None listed