DRKS00028473尚未招募4 期
Functional outcome and painrelief in patients with osteoarthritis of the knee due to oral intake of UC II (undenaturated collagen Typ II):A multicenter, prospective, randomised, placebo controlled clinical trial - OIUC2
Orthopädie im MediaparkMediaPark Klinik Köln0 个研究点目标入组 202 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Sufficiently severe gonarthrosis grade II and III according to the nativradiological criteria according to Kellgren/Lawrence or magnetic resonance imaging criteria according to Outerbridge.
- •Diagnosis confirmed by standard X-ray (AP, lateral, patella tangential, Rosenberg, whole leg) or MRI
- •Age: 50-70 years
- •Gender: both
排除标准
- •Exclusion criteria (knee-related)
- •- Arthrofibrosis
- •- Extension deficit (<20°)
- •- Flexion deficit (> 100°)
- •- Insufficiency of the anterior and/or posterior cruciate ligament
- •- Intra-articular injections with corticosteroid, hyaluronic acid and PRP in the last 3 months
- •- Chronic use of medication with effect on the joint (e.g. corticoid)
- •Exclusion criteria (not knee related)
- •- Insufficient German language skills
- •- Immunological diseases / autoimmune diseases / rheumatic disease
- •- Age < 50 years; age > 70 years
- •- BMI > 35
- •- Neurological diseases (e.g. Parkinson's disease, self-reported)
- •- Major other lower extremity injuries / surgeries (e.g.
- •insufficient cruciate ligaments)
- •- Leg axis deviation > 15° (varus or valgus)
- •- Breastfeeding or pregnant women
- •- Dementia
- •- Severe psychological disorder(s)
- •- Alcohol abuse
- •- Disseminated malignancy
- •- Severe systemic disease
- •- Hyperuricemia
- •- Acute local or septic infection
研究者
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