Status:
COMPLETED
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
Lead Sponsor:
AgNovos Healthcare, LLC
Conditions:
Hip Fractures
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
65+ years
Phase:
NA
Brief 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 r...
Detailed Description
The research will be conducted as a prospective single-center study within Hong Kong. The maximum number of subjects to be treated is twenty (20). This will be a non-randomized and non-blinded study. ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\*.
- Subject exhibits excessive alcohol consumption as determined by the principal investigator\*.
- Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip.
- Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
- Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
- Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease).
- Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
- Subject has a history of radiation therapy to the hip or pelvic region.
- Subject has history of chemotherapy treatment for any condition within the previous five years.
- Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years.
- Subject has known allergies to implanted device.
- 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.
- Subject is currently enrolled in another clinical study.
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03268356
Start Date
August 15 2017
End Date
December 31 2020
Last Update
November 30 2022
Active Locations (1)
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1
Queen Mary Hospital - Department of Orthopaedics and Traumatology
Hong Kong, Hong Kong