NL-OMON46331已完成4 期
Prospective longitudinal outcome study assessing the use of BonAlive bioactive glass for attaining eradication of osteomyelitis and stimulation of bone healing in patients requiring surgery in osteomyelitic bone defects. - BonAlive HRpQCT study
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 18 至 99（—）
入选标准
- •Patients eligible for inclusion in this study are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+. ;
- •Subjects meeting all of the following criteria will be included in the study.;1. Patients with chronic (>12 weeks) osteomyelitis located in the distal tibia, distal fibula, ankle or foot. Or located in de distal radius, distal ulna, wrist or hand.
- •2. Patients who are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+.
- •3. Patients that have normal contralateral bone, which will be used as an internal control.
- •4. Patients who accepted and signed the ethics committee approved informed consent before the first HR-pQCT scan.
- •5. Male and non-pregnant female patients between 18-70 years of age.
- •6. Patients who are physically and mentally able and willing to comply with the regulations of this study.
- •7. Patient can read and understand the Dutch language.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study.;1. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- •2. Patients with chronic osteomyelitis associated with fracture in need of osteosynthesis surgery
- •3. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- •4. Obese patients where obesity is severe enough to affect subject*s ability to perform activities of daily living (body mass index, kg/m2 > 40)
- •5. Patients with malignancy - active malignancy within last 1 year
- •6. Patients known with a diagnosed systemic disease that would affect the subject*s welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget*s disease, renal osteodystrophy, hypercalcaemia) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- •7. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- •8. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
- •9. Patients with a known sensitivity to, specific antibiotics or radiation.
- •10. Patients under age of 18 and above age of 70
- •11. Females who wish to become pregnant before, during or after (up to two years) the course of their treatment.
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