Ignite Creation Date:
2025-12-18 @ 9:35 AM
Ignite Modification Date:
2025-12-23 @ 10:49 PM
Study NCT ID:
NCT05202678
Status:
None
Last Update Posted:
2025-01-31 00:00:00
First Post:
2021-09-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo- Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis
Status:
None
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To qualify for this study, a subject must have at least one intact hip with bone loss attributable to osteoporosis as indicated by a femoral neck DXA T-score of -2.5 or less.
Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.
Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: