STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture (NCT03268356) | Clinical Trial Compass
CompletedNot Applicable
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
Hong Kong13 participantsStarted 2017-08-15
Plain-language summary
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
Who can participate
Age range65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is a postmenopausal female
✓. Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
✓. Subject is ≥ 65 years of age.
✓. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
✓. Subject is capable of giving written informed consent to participate in the study.
Exclusion criteria
✕. Subject has a prior diagnosis of secondary osteoporosis.
✕. Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
✕. Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
✕. Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
✕. Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
✕. Subject has insulin-dependent diabetes mellitus (IDDM).
✕. Subject has Body Mass Index (BMI) \> 30.
What they're measuring
1
Incidence of Treatment or Device Emergent Serious Adverse Events