CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP

Condition(s) studied

Investigational drug(s) / intervention(s)

Clinical imaging is performed during the 24 and 60 month follow-up visits: X-ray and DXA scan

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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