NL-OMON51693
Recruiting
Not Applicable
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 - RECONFIRM
AgNovos Healthcare0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- proximal femur with high risk for fragility fracture
- Sponsor
- AgNovos Healthcare
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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