Osteoporosis
Conditions
Keywords
local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate, LOEP, CONFIRM Extension
Brief summary
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
Interventions
OTHERClinical imaging is performed during the 24 and 60 month follow-up visits
X-ray and DXA scan
Sponsors
AgNovos Healthcare, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment. * Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study. * Subject is capable of giving written informed consent to participate in the study.
Exclusion criteria
* Subject was withdrawn from CONFIRM. * Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DXA score at 24 months | 24 months | Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DXA score at 60 months | 60 months | Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment. |
| Hip fracture incidence | 60 months | The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment. |
| Radiologic bone formation | 60 months | Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 60 months | The incidence of all serious adverse events during follow-up determined to be at least possibly related to the procedure and/or device through 60 months post-AGN1 LOEP treatment. |
Countries
Belgium
Outcome results
None listed