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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- AgNovos Healthcare, LLC
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Femoral Neck Bone Mineral Density
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
Detailed Description
To qualify for this study, a subject must have at least one intact hip with bone loss attributable to osteoporosis as indicated by a femoral neck DXA T-score of -2.5 or less. Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is a postmenopausal female (at least 1-year post menses).
- •Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
- •Subject has at least one hip without previous surgery or fracture.
- •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.
- •Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- •Subject is capable of giving written informed consent to participate in the study.
Exclusion Criteria
- •Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
- •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, extraarticular soft tissue pathology, referred pain, tumor, stress fracture or infection.
- •Subject is dependent on the use of a wheelchair or is bedridden.
- •Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
- •Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min or is being treated with dialysis.
- •Subject has hemoglobin A1c level ≥ 7.5%.
- •Subject has Body Mass Index (BMI) \>
- •Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\*.
- •Subject is at ASA Class III, IV, V or VI.
- •Subject exhibits excessive alcohol consumption as determined by the principal investigator\*.
Outcomes
Primary Outcomes
Femoral Neck Bone Mineral Density
Time Frame: 12 months
6% increase in mean femoral neck BMD from preprocedure baseline to 12 months post-procedure of treated hips
Primary Safety Evaluation
Time Frame: 12 months
The incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up period determined to be at least possibly related to the procedure and/or device.
Secondary Outcomes
- Total Hip Bone Mineral Density(24 months)
- Femoral Neck Bone Mineral Density(24 months)