NL-OMON54110招募中不适用
Grip on knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for young knee osteoarthritis patients in regular care. - GODIVA
niversitair Medisch Centrum Utrecht0 个研究点目标入组 1,200 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
- 招募中
- 发起方
- 入组人数
- 1,200
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 99（—）
入选标准
- •- Clinical diagnosis of knee OA
- •- Age <= 65 years and >= 18 years
- •- Persistent, refractory pain, insufficiently responding to conservative and
- •previous non-surgical therapy
- •- Structural OA joint damage, indicated by a K&L grade of at least 2
- •- Able to wear an external fixator and care for it for 6 weeks
- •- Accepting that the maximal effect of KJD is not present directly after
- •removal of the frame but may take months after frame removal
- •- Sufficient joint stability (according to the orthopedic surgeon*s judgement)
- •- Flexion (>100 degrees) and extension range (<10 degrees)
- •- Weight and BMI <120 kg and <35 kg/m2 respectively
排除标准
- •- Surgical intervention in last 6 months
- •- Leg-axis deviation > 10 degrees
- •- Serious osteopenia making placing bone-pins and wearing a frame into a risk
- •(according to the orthopedic surgeon*s judgement)
- •- Coagulation problems making occurrence of thrombosis or embolies into a risk
- •(according to the orthopedic surgeon*s judgement)
- •- Existing endoprosthesis at another joint (i.e., hip or contralateral knee) to
- •prevent infection of existing prosthesis
- •- History or presence of joint infection/inflammation
- •- Hypersensitivity to antibiotics
- •- Presence of systemic inflammatory disease, like rheumatoid arthritis
- •For the substudy: Inability to undergo a knee-MRI or knee-CT and DEXA according
- •to the local enforced criteria in regular health care.
研究者
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