Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- incidence of surgical revisions
研究概览
简要总结
This observational study is to document the application of human bone graft in the surgical treatment (epiphysiodesis) of leg length discrepancy or primordial gigantism and its subsequent healing process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned epiphysiodesis to stop the growing of a bone indicated by leg length discrepancies or primordial gigantism
- •Age 10-18 years
- •Written consent to participate in the study after previous written and oral education (additional consent for the participation of minors in the study after prior written and oral education by at least one parent)
排除标准
- •Insufficient knowledge of the german language
- •Foreseeable compliance issues
- •Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
- •Patients with non-treated pre-existing conditions, which could be the cause of leg length differences
- •Active osteomyelitis
- •Ulcerations in the area of the skin of the surgical area
- •Immunosuppressive drugs that can not be discontinued
结局指标
主要结局
incidence of surgical revisions
时间窗: 1 year
Was a surgical revision done postoperatively? YES/NO
incidence of a dislocation of the screw
时间窗: 1 year
based on x-rays or MRI: Is the screw dislocated? YES/NO
sclerosing around the screw
时间窗: 1 year
based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO
formation of a bone bridge
时间窗: 1 year
based on x-rays or MRI: Is as formation of a bone bridge visible? YES/NO How many millimeters? mm
incidence of additional surgery
时间窗: 1 year
Was an additional surgery necessary to stop growth? YES/NO; Which one?
incidence of cracking of the screw
时间窗: 1 year
based on x-rays or MRI: Is a crack of the screw visible? YES/NO
cystic brightening around the screw
时间窗: 1 year
based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO
incidence of postoperative inflammatory complications
时间窗: 1 year
Is a postoperative inflammatory complication recognizable? YES/NO
evaluation of postoperative pain (VAS)
时间窗: 1 year
The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.
次要结局
- evaluation of swelling(1 year)
- Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)(1 year)
- evaluation of hematoma(1 year)
- evaluation of wound healing disorder(1 year)
- International Knee Documentation Committee Subjective Knee Form (IKDC Score)(1 year)
- patient satisfaction (VAS)(1 year)
- Revised questionnaire to assess Health-Related Quality of Life in children and adolescents (KINDL)(1 year)
研究者
Catharina Chiari
Univ. Prof. Dr. Catharina Chiari, MSc
Medical University of Vienna