NL-OMON54786招募中不适用
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures - RESTORE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 and at least 65 years of age. 2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip. 3. Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject interview or legally authorized representative (LAR) interview or medical record review): • Documented falls assessment indicating subject is at moderate or high risk of falls • Falls history (2 or more falls in the previous 12 months) • History of vertigo, dizziness, or postural hypotension • Documented T-score < -2.5 at the hip • Taking more than 3 daily prescription medications • Visual impairment as confirmed by one of the following: o Subject reports difficulty seeing o Lack of depth perception or vision loss in one eye o Macular degeneration o Cataracts • Prior non-hip fragility fracture • Cognitive frailty as assessed by SPMSQ (mild cognitive impairment), memory problems, or delirium • Parkinson*s disease stage 3 or 4 • 10-year hip fracture probability >15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country 4. Subject is expected to be ambulatory after the hip fracture repair procedure. 5. Informed consent is provided by the subject or the subject*s LAR 6. The subject*s willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.
排除标准
- •1. Subject hospital admission is > 24 hours from the time of the index hip fracture. 2. Subject was dependent on the use of a wheel-chair or was bedridden prior to the index hip fracture. 3. Subject is currently enrolled in another interventional clinical study. 4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture. 5. Subject has one or more new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, and/or recovery or subject has three or more new fractures in addition to the index hip fracture. 6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment. 7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side. 8. 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. 9. Subject is at ASA Class IV, V, or VI. 10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget*s disease, renal osteodystrophy, or osteomalacia). 11. Subject has a history of tuberculous spondylitis. 12. Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years. 13. Subject has chronic cardiac insufficiency or severe cardiovascular disease as assessed by a subject or LAR interview to be NYHA Class III or IV or has an implanted pacemaker. 14. Subject has a history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, unstable angina, pulmonary embolus, deep vein thrombosis, ventricular tachycardia, or atrial fibrillation) in the last 3 months. 15. Subject is on oral or parenteral immuno-suppressive drugs. 16. Subject has uncontrolled diabetes mellitus. 17. Subject has Hb <= 9 g/dL at admission. 18. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) <= 30 mL/min. 19. Subject has albumin corrected serum calcium levels outside the normal laboratory range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia). 20. Subject has a Parker Mobility Score <= 5. 21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ score of 5 or higher. 22. Subject has known allergies to calcium-based bone void fillers. 23. 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). 24. Subject fails pre-operative or intraoperative eligibility criteria Pre-operative eligibility criteria The subject will be evaluated immediately before beginning the hip fracture surgery. The subject will not proceed in the study if they have experienced any of the following changes or complications: • Change in ASA Class to IV, V, or VI • Occurrence or relevant suspicion of cardiovascular events (e.g. stroke, tran
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