NCT01562366已完成不适用
A Randomised, Controlled, Double-blind Clinical Investigation on the Efficacy and Safety of Radiofrequency Micro Debridement, Topaz, in Recalcitrant Greater Trochanteric Pain Syndrome (GTPS) vs. Standard of Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Modified Harris Hip Score
研究概览
简要总结
Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference between the two treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged between 40-70 years old, females and males are eligible
- •A history of > 6 months of conservative care treatment for lateral hip pain, including but not limited to local anaesthetic and steroid injections into the trochanteric bursa
- •Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
- •Willing to comply with the protocol and follow-up visits
- •Signed the Independent Ethics Committee (IEC) approved Informed Consent Form
排除标准
- •Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
- •Subjects with sero-positive or sero-negative arthropathy
- •Long term steroid use > 6 weeks
- •Allergy to drugs to be used in the procedure
- •Medical co-morbidities that preclude surgical intervention
- •Inability to understand or respond to the study questionnaires
- •Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
- •Subjects who are simultaneously participating in another device or pharmaceutical investigation
- •Intra-operative Exclusion:
- •Abductor tears
- •Severe tendinopathy
结局指标
主要结局
Modified Harris Hip Score
时间窗: 6 months
This is a patient questionnaire used to evaluate hip function following surgery.
次要结局
- Visual Analogue Scale(1 year)
- Ultrasound findings(1 year)
- SF-12 Health Survey(1 year)
- Adverse events(1 year)
- The Western Ontario and McMaster Universities Arthritis Index(1 year)
- Duration of surgery between two treatment groups(1 day)
研究者
研究点 (2)
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