NL-OMON45556撤回不适用
ser-friendliness of *ArthroSave*s Knee-Reviver* compared to *Stryker mono-tubes* in case of knee distraction as treatment for knee osteoarthritis.<br> - User-friendly knee-distraction
niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
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
- 18 至 64（—）
入选标准
- •- adults *65 years of age (at higher ages cost-benefit is becoming less; 15)
- •- BMI < 35 kg/m2 (mechanical safety limit of device) (with max 110 kg body weight)
- •- Normal-good physical condition (arbitrary defined by orthopaedic surgeons)
- •- Sufficient knee joint stability (arbitrary defined by orthopaedic surgeons)
- •- Sufficient range of motion (arbitrary defined by orthopaedic surgeons)
- •- Radiographic signs of joint damage (KL grade 2-4)
- •- VAS (visual analogue scale) pain >40/100 (conservative treatment resistant)
排除标准
- •General: Patients that would not be considered for arthroplasty or osteotomy because of psychosocial condition; or who meet any of the following criteria will be excluded from participation in this study:
- •- Comorbidities that would compromise the efficacy of knee joint distraction (arbitrary defined by orthopaedic surgeons)
- •- History of inflammatory or septic arthritis
- •- Knee mal-alignment of more than 10 degrees
- •- Previous surgical interventions of the index knee < 6 months ago
- •- Absence of any joint space width on both sides (medial and lateral) of X-ray
- •- presence of an endo-prostheses elsewhere
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