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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Merz Investigative Site #0010358
Vista, California, United States
Number of Participants With X-ray of Either Hand With Bone Obscuration at 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.
Time frame: Month 1
Number of Participants With X-ray of Either Hand With Bone Obscuration at 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.
Time frame: Month 6
Number of Participants With X-ray of Either Hand With Bone Obscuration at 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.
Time frame: Month 12
Number of Participants With X-ray of Either Hand With Bone Obscuration at 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.
Time frame: Month 24
Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6
Time frame: Months 1 and 6
Michigan Hand Outcomes Questionnaire (MHQ) Scores
The MHQ is a hand-specific outcomes instrument that measures outcomes of participants with conditions of, or injury to, the hand or wrist. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics and satisfaction. For this study, MHQ overall hand function and MHQ pain domains were evaluated. Scores for both scales range from 0-100. Higher MHQ hand function scores denote better hand performance whereas higher MHQ pain scores denote more pain. MHQ minimal clinically important differences were defined as score changes greater than an 11-point increase for the pain domain and greater than a 13-point decrease for the function domain.
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Time frame: Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24
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
The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a "snap-shot" at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
Time frame: Months 1 and 6
Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12
The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a "snap-shot" at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
Time frame: Months 7 and 12
Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6
The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
Time frame: Months 1 and 6
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12
The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
Time frame: Months 7 and 12