Radiesse® Post Approval Safety Study - Radiological Evaluation of Implantation in the Hands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1
研究概览
简要总结
The objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.
详细描述
Radiesse dermal filler is radiopaque and shows no overt radiographic safety concerns in a study of 58 patients after facial implantation, with Radiesse not always visible on plain X-rays.
This Post Approval Safety study will evaluate if there are concerns after Radiesse implantation in the dorsum of hands, specifically if implantation interferes with radiological assessment by obscuring the bones of the hand.
Hands will be scored according to the 5 point Merz Hand Grading Scale (MHGS), which ranges from 0 (No loss of fatty tissue) to 4 (Very severe loss of fatty tissue; marked visibility of veins and tendons).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator.
- •Is at least 22 years of age.
- •Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
排除标准
- •Was a participant in the Radiesse hands pre-market clinical study.
- •Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
- •Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).
研究组 & 干预措施
"Grade 4 Hands" group
"Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period.
干预措施: Radiesse injectable implant and 2% lidocaine HCL (Device)
"Grade 2 or 3 Hands" group
"Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period.
干预措施: Radiesse injectable implant and 2% lidocaine HCL (Device)
结局指标
主要结局
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1
时间窗: Month 1
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6
时间窗: Month 6
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12
时间窗: Month 12
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24
时间窗: Month 24
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
次要结局
- Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6(Months 1 and 6)
- Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6(Months 1 and 6)
- Michigan Hand Outcomes Questionnaire (MHQ) Scores(Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24)
- Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12(Months 7 and 12)
- Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6(Months 1 and 6)
- Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12(Months 7 and 12)