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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.
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).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Volume Loss in the Dorsum of the Hand
Radiesse injectable implant and 2% lidocaine HCL
Active, not recruiting
Merz Pharmaceuticals, LLC
Published on BioPortfolio: 2016-11-01T07:23:21-0400
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.
The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial ...
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand rejuvenation.
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine.
The recent approval in 2015 of Radiesse for injection into the hand by the FDA has spurred an increase in interest among patients and clinicians in nonsurgical hand rejuvenation using fillers. Applica...
Paradigms in the treatment of aging have evolved to address volume loss as a central and primary hallmark of the aging face. The concept of "composite volumization" was recently proposed by Dr. Z. Pau...
Volume restoration using filler in the dorsum of the hand is a simple and effective procedure to improve wrinkles and to hide veins and tendons. Currently, Calcium-Hydroxyapatite (CaHA)-filler is the ...
Loss of facial volume and soft-tissue support are common to types of facial aging. Restoration of a youthful appearance relies upon correction of this loss, and can be achieved in various capacities t...
Implant-related infections in hand surgery are dreaded complications, potentially leading to loss of finger joint function or amputation. Knowledge about the clinical presentation and treatment concep...
The volume of BLOOD passing through the HEART per unit of time. It is usually expressed as liters (volume) per minute so as not to be confused with STROKE VOLUME (volume per beat).
Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.
Guided BONE TRANSPLANTATION of the MAXILLARY SINUS surface with a BONE SUBSTITUTE grafting. It increases the bone volume at the site of the DENTAL IMPLANT and helps stabilize it.
The volume of air contained in the lungs at the end of a maximal inspiration. It is the equivalent to each of the following sums: VITAL CAPACITY plus RESIDUAL VOLUME; INSPIRATORY CAPACITY plus FUNCTIONAL RESIDUAL CAPACITY; TIDAL VOLUME plus INSPIRATORY RESERVE VOLUME plus functional residual capacity; or tidal volume plus inspiratory reserve volume plus EXPIRATORY RESERVE VOLUME plus residual volume.
The volume of the HEART, usually relating to the volume of BLOOD contained within it at various periods of the cardiac cycle. The amount of blood ejected from a ventricle at each beat is STROKE VOLUME.
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...