NL-OMON51693招募中不适用
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 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •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
排除标准
- •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
研究者
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