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
- Conditions
- proximal femur with high risk for fragility fractureosteoporosisproximal femur bone mineral density
- Registration Number
- NL-OMON51693
- Lead Sponsor
- AgNovos Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Subject is a postmenopausal female (at least 1-year post menses).
2. Subject has bone loss in the hip attributable to osteoporosis as defined by
a femoral neck DXA T-score of -2.5 or less.
3. Subject has at least one hip without previous surgery or fracture.
4. Subject is medically stable from any previous treatment or medical procedure
in the opinion of the investigator and with an ASA score of I or II.
5. Subject has willingness, ability, and commitment to participate in baseline
and follow-up evaluations for the full length of the study.
6. Subject is capable of giving written informed consent to participate in the
study.
1. Subject is less than 3 months removed from having a hip fracture repair or
prosthesis or elective Total Hip Arthroplasty (THA).
2. Subject has progressive increase in hip pain over the previous six (6)
months that in the opinion of the Investigator suggests moderate to severe
intra-articular arthritis, labral tear, extra-articular soft tissue pathology,
referred pain, tumor, stress fracture or infection.
3. Subject is dependent on the use of a wheelchair or is bedridden.
4. Subject has albumin corrected serum calcium levels outside the normal lab
range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia)
5. Subject has severe renal insufficiency defined as an estimated glomerular
filtration rate (eGFR) < 30 mL/min or is being treated with dialysis
6. Subject has hemoglobin A1c level >= 7.5%.
7. Subject has Body Mass Index (BMI) > 35.
8. Subject exhibits excessive smokeless tobacco use or excessive smoking as
determined by the principal investigator*.
9. Subject is at ASA Class III, IV, V or VI.
10. Subject exhibits excessive alcohol consumption as determined by the
principal investigator*.
11. Subject has radiological evidence of gross bony or joint pathology of the
hip, including signs predictive of atypical femoral fractures (e.g., Cortical
beaking) or has been diagnosed and/or treated for atypical femoral fractures.
12. Subject treated with corticosteroids or systemic glucocorticoids for ten
(10) days in the previous six (6) months.
13. Subject has history of oral or parenteral use of immune-suppressive drugs
in the previous twelve months.
14. Subject has history of metabolic bone disease other than osteoporosis (ex.
Paget*s disease).
15. Subject has a history of auto-immune hip arthritic diseases including
rheumatoid, psoriatic, or those associated with systemic lupus erythematosus,
spondyloarthropathy, Reiter*s Syndrome or Crohn*s Disease.
16. Subject has a history of radiation therapy to the hip or pelvic region.
17. Subject has a history of any invasive malignancy (except basal cell
carcinoma), unless treated and with no clinical signs or symptoms of the
malignancy for five (5) years.
18. Subject has known allergies to implanted device.
19. In the judgement of the Investigator, the subject is not a good study
candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor
general physical/mental health, or drug or alcohol abuse issues).
20. Subject is currently enrolled in another clinical study.
*AgNovos*s recommendation is >1 pack per day smoking and >3 alcoholic drinks
per day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary performance endpoint is 6% increase in mean femoral neck BMD from<br /><br>pre-procedure baseline to 12 months post-procedure of treated hips.<br /><br>The primary safety evaluation is the incidence of all adverse events and<br /><br>serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up<br /><br>period determined to be at least possibly related to the procedure and/or<br /><br>device.</p><br>
- Secondary Outcome Measures
Name Time Method