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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
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 #0010393
Sacramento, California, United States
Merz Investigative Site #0010321
San Diego, California, United States
Merz Investigative Site #0010358
Vista, California, United States
Merz Investigative Site #0010099
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
Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.
Time frame: Month 6
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
Proportion refers to percentage of subjects with device-and/injection-related severe TEAEs.
Time frame: Month 24
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24
The ROM was assessed using a Jamar finger goniometer. This test passively and actively measured the angle of motion of all five metacarpophalangeal joints in each hand right and left by determining the flexion and extension angles. The flexion determined how far each finger could be flexed at the metacarpophalangeal joint toward the palm. The extension determined how each finger could be extended at the metacarpophalangeal joint away from the palm. Degree scale ranges from 0 to 180 degree. Lower values in flexion angle and extension angle means more deterioration in hand function.
Time frame: Baseline, Month 24
Change From Baseline in Functional Dexterity in Each Hand at Month 24
The functional dexterity test (FDT) assessed the fine motor skills (dexterity) that means it assessed the subject's ability to use the hand for daily tasks requiring the 3-jaw chunk prehensions that is buttoning, tying shoelaces, screwing a nut and bolt, and lacing yarn using a 16-hole peg board. Functional Dexterity was measured by noting the time in seconds on stopwatch for a hand to invert pegs on a 16-hole pegboard and this test assessed the ability to use hand for daily tasks. Longer times to complete the functional dexterity test means deterioration in hand function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
West Hollywood, California, United States
Merz Investigative Site #0010405
New York, New York, United States
Merz Investigative Site #0010406
New York, New York, United States
Merz Investigative Site #0010322
Austin, Texas, United States
Merz Investigative Site #0010125
Plano, Texas, United States
Merz Investigative Site #0010392
Spokane, Washington, United States
Time frame: Baseline, Month 24
Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24
Sensation in the dorsum of each hand was conducted using a Semmes-Weinstein monofilament touch test. This was assessed using an index finger touch protocol, where by study subject was asked to report when a 2 to 3 centimeter (cm) light touch is felt at 3 different areas of the dorsum of each hand. Sensation results were coded for analysis such as response to 2.83 filament = 1, response to 3.61 filament = 2, response to 4.31 filament = 3, response to 4.56 filament = 4, response to 6.65 filament = 5, and no response to either filament = 6. For sensation testing a value of 1 (response to 2.83 filament) is considered normal while a value of 2 (response to 3.61) would show diminished light touch. Score ranges from 1 to 6. A higher value in sensation measurements is associated with a deterioration in hand function.
Time frame: Baseline, Month 24
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24
Hand strength was assessed in two ways grip and pinch strengths. Grip strength was assessed using a standard, adjustable-handle Jamar hydraulic hand dynamometer. Pinch strength was assessed in three different ways such as tip (two-point) pinch, key (lateral) pinch, and palmar (three-jaw chuck) pinch using the Jamar hydraulic pinch gauge. Lower values (pounds) in hand grip and pinch strength are associated with deterioration in function.
Time frame: Baseline, Month 24
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
The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating 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: Month 3
Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21
The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating 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 9, 15, and 21
Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment
The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Time frame: Month 3
Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21
The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Time frame: Months 9, 15, and 21