JPRN-jRCT2022210008招募中未知
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP)to Prevent Secondary Hip Fractures in Osteoporotic Women UndergoingTreatment of Index Hip Fractures - RESTORE
owe Adam0 个研究点目标入组 2,400 人开始时间: 2021年6月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 2,400
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
- >= 65age old 至 ot applicable（—）
- 性别
- Female
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, 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:
- •Subject reports difficulty seeing
- •Lack of depth perception or vision loss in one eye
- •Macular degeneration
- •-Prior non-hip fragility fracture
- •-Cognitive frailty as assessed by SPMSQ (mild cognitive impairment) or delirium
- •-Parkinsons 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 subjects legally authorized representative.
- •6. The subjects 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 wheelchair or was bedridden prior to the index hip fracture.
- •3. Subject is currently enrolled in another 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.
- •6. Subject has an infection at the LOEP intended treatment site or has nonintact 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
- •9. Subject is at ASA Class IV, V, or VI.
- •10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Pagets disease, renal osteodystrophy, or osteomalacia).
- •11. Subject has a history of tuberculous spondylitis.
- •12. Subject has a history of any invasive malignancy (except nonmelanoma 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 severe cognitive impairment as assessed by SPMSQ.
- •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 as specified in section 7.4.2. of the clinical investigation plan.
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