NCT02831868Unknown不适用
Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- A change in IMA angle
研究概览
简要总结
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
- •Subject weighing <100 kg and body mass index (BMI) <32 kg/m
- •Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
- •Able and willing to comply with the requirements of the protocol.
- •Able to understand and sign written informed consent to participate in the study.
排除标准
- •Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
- •History of:
- •a. Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 < iii. any known complications of diabetes (PVD, Nephropathy [CR>1.3], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP).
- •c. Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-
- •e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT
- •g. Fracture (past or present) of MT1 or MT
- •Aseptic necrosis or any deformity of MT2 head.
- •Aseptic necrosis of the MT1 head
- •Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- •ASA grade above 2
研究组 & 干预措施
EXP
Experimental
Implantation of a HAVAI device to correct HVA without osteotomy
干预措施: HAVAI (Device)
结局指标
主要结局
A change in IMA angle
时间窗: 50 weeks
A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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