NCT05829733招募中不适用
6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aptissen SA
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Evolution of the Oxford Hip Score (OXFORD 12)
研究概览
简要总结
Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age,
- •Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:
- •Treated hip pain: Oxford score ≥ 21/60,
- •Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),
- •Symptoms related to osteoarthritis of the hip for at least 2 months,
- •Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),
- •Informed consent form signed by the patient,
- •The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).
排除标准
- •Pregnancy,
- •Participation in another clinical trial,
- •Skin lesion near the injection site,
- •Recent or old infection of the affected joint,
- •Patient with a programmed arthroplasty,
- •Patient with a pathology that makes decision-making impossible,
- •The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.
结局指标
主要结局
Evolution of the Oxford Hip Score (OXFORD 12)
时间窗: 6 months (M6)
Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms.
次要结局
- Hip prosthesis placement after the injection(Month 6)
- Evolution of the Oxford Hip Score (OXFORD 12)(Month 3, Month 3 to Month 6)
- Self-assessment symptoms evolution(Month 3, Month 3 to Month 6)
- MCID Oxford Hip Score (OXFORD 12)(Month 3, Month 3 to Month 6)
研究者
研究点 (5)
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