NCT02949921

Radiological Evaluation of Radiesse Implantation in the Hands

Radiesse® Post Approval Safety Study - Radiological Evaluation of Implantation in the Hands

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Volume Loss in the Dorsum of the Hand

Interventions

Type	Name	Description
DEVICE	Radiesse injectable implant and 2% lidocaine HCL	Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-01-02
• Completion: 2018-01-02
• First posted: 2016-10-31
• Last updated: 2023-11-29
• Results posted: 2019-03-14

Locations

1 site across 1 country: United States