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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
60
X-ray and DXA scan
AZ Nikolaas
Sint-Niklaas, Sint-Niklaas, Belgium
Change in DXA score at 24 months
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
Time frame: 24 months
Change in DXA score at 60 months
Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
Time frame: 60 months
Hip fracture incidence
The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.
Time frame: 60 months
Radiologic bone formation
Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.
Time frame: 60 months
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