NCT01431560已完成4 期
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- American Orthopaedic Foot and Ankle Society(AOFAS) score
研究概览
简要总结
The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature subjects (≥16 years old) with unilateral ankle fractures
排除标准
- •subjects less than 16 years old,
- •subjects not followed up at this hospital,
- •multiple injuries,
- •bilateral ankle fractures,
- •open fractures,
- •pathologic fractures,
- •concomitant tibial shaft fractures,
- •previous history of immobilization due to significant injury or a fracture of either ankle,
- •significant peripheral neuropathy,
- •soft tissue infection in the region on either injured ankle,
- •or inability to complete the study protocol
结局指标
主要结局
American Orthopaedic Foot and Ankle Society(AOFAS) score
时间窗: 3 months, 6 months, 1 year
change from baseline(3 months after surgery)
次要结局
- Short Musculoskeletal Functional Assessment(SMFA) scale(3 months, 6 months, 1 year)
研究者
Jung Ho Noh
Orthopaedic Surgeon
National Police Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of rigid ankle foot orthoses and ankle foot orthoses with oil damper plantar-flexion resistance on thorax and pelvis movements of stroke patients during gaitCerebrovascular diseaseJPRN-UMIN000038694International University of Health & Welfare34
已完成
不适用
Assessment of Preoperative and Postoperative Ankle KinematicsAnkle OsteoarthritisNCT05868759Istituto Ortopedico Rizzoli24
招募中
Unknown
Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance in subacute hemiplegia patients -a series of single case designStrokeJPRN-UMIN000052001Medical Corporation Juryo Kumamoto Kinoh Hospital6
Unknown
不适用
Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle FractureAnkle FractureRehabilitationNCT02029170Hallym University Medical Center192
招募中
不适用
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee JointOsteochondral DefectOsteochondral FractureOsteochondral Fracture of PatellaOsteochondritis DissecansNCT06462040Istituto Ortopedico Rizzoli100