Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 9
- 主要终点
- Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6
研究概览
简要总结
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
详细描述
This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B).
Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.
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 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.
- •Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.
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 AEs.
结局指标
主要结局
Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6
时间窗: Month 6
Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.
次要结局
- Number of Subjects With MHGS Scores Greater Than or Equal (>=) to 1-point Improvement From Baseline in Both Hands at Month 3 After Initial Treatment(Month 3)
- Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment(Month 3)
- Proportion of Subjects With Device-and/Injection-related Severe TEAEs in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 24(Month 24)
- Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21(Months 9, 15, and 21)
- Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24(Baseline, Month 24)
- Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24(Baseline, Month 24)
- Change From Baseline in Functional Dexterity in Each Hand at Month 24(Baseline, Month 24)
- Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24(Baseline, Month 24)
- Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21(Months 9, 15, and 21)