Volume Loss in the Dorsum of the Hand
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Merz North America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator. 2. Is at least 22 years of age. 3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study. 4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.
Exclusion criteria
1. Was a participant in the Radiesse hands pre-market clinical study 2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands. 3. Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Month 6 | Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Baseline, 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. |
| Change From Baseline in Functional Dexterity in Each Hand at Month 24 | Baseline, 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. |
| Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 | Baseline, 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. |
| Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Baseline, 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. |
| 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 | Proportion refers to percentage of subjects with device-and/injection-related severe TEAEs. |
| Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21 | 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). |
| 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 | 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). |
| Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21 | 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). |
| 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 | 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). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 9 investigational sites in the United States.
Pre-assignment details
A total of 256 subjects were enrolled and treated, out of which 216 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Group A: MHGS Grade 4 Hands Group Subjects with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18. | 130 |
| Group B: MHGS Grade 2 or 3 Hands Group Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18. | 126 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 10 | 17 |
| Overall Study | Non-compliant | 3 | 1 |
| Overall Study | Sponsor instructed | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Group A: MHGS Grade 4 Hands Group | Group B: MHGS Grade 2 or 3 Hands Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 59 Participants | 19 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 107 Participants | 178 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 118 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin type Type I | 13 Participants | 12 Participants | 25 Participants |
| Fitzpatrick skin type Type II | 63 Participants | 65 Participants | 128 Participants |
| Fitzpatrick skin type Type III | 38 Participants | 39 Participants | 77 Participants |
| Fitzpatrick skin type Type IV | 11 Participants | 7 Participants | 18 Participants |
| Fitzpatrick skin type Type V | 3 Participants | 0 Participants | 3 Participants |
| Fitzpatrick skin type Type VI | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 122 Participants | 117 Participants | 239 Participants |
| Region of Enrollment United States | 130 Participants | 126 Participants | 256 Participants |
| Sex: Female, Male Female | 128 Participants | 118 Participants | 246 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 130 | 0 / 126 |
| other Total, other adverse events | 70 / 130 | 57 / 126 |
| serious Total, serious adverse events | 9 / 130 | 3 / 126 |
Outcome results
Primary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | 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 | 1.5 percentage of subjects |
| Group B: MHGS Grade 2 or 3 Hands Group | 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 | 0 percentage of subjects |
Secondary
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.
Time frame: Baseline, Month 24
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Functional Dexterity in Each Hand at Month 24 | Change at Month 24: Left Hand | -6.29 seconds | Standard Deviation 13.5 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Functional Dexterity in Each Hand at Month 24 | Change at Month 24: Right Hand | -4.53 seconds | Standard Deviation 7.9 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Functional Dexterity in Each Hand at Month 24 | Change at Month 24: Left Hand | -3.76 seconds | Standard Deviation 4.82 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Functional Dexterity in Each Hand at Month 24 | Change at Month 24: Right Hand | -3.89 seconds | Standard Deviation 5.34 |
Comparison: Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Grip Strength: Left Hand | -3.63 pounds | Standard Deviation 8.68 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Grip Strength: Right Hand | -2.28 pounds | Standard Deviation 7.36 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Tip Pinch Strength: Left Hand | 1.26 pounds | Standard Deviation 2.94 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Tip Pinch Strength: Right Hand | 1.60 pounds | Standard Deviation 2.99 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Key Pinch Strength: Left Hand | 0.90 pounds | Standard Deviation 2.88 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Key Pinch Strength: Right Hand | 1.33 pounds | Standard Deviation 2.99 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24,Palmar Pinch Strength:Left Hand | 0.68 pounds | Standard Deviation 2.78 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24,PalmarPinch Strength:Right Hand | 0.54 pounds | Standard Deviation 3.04 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24,PalmarPinch Strength:Right Hand | 0.40 pounds | Standard Deviation 3.04 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Grip Strength: Left Hand | -4.65 pounds | Standard Deviation 11.17 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Key Pinch Strength: Left Hand | 1.12 pounds | Standard Deviation 2.76 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Grip Strength: Right Hand | -3.37 pounds | Standard Deviation 10.85 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24,Palmar Pinch Strength:Left Hand | 0.43 pounds | Standard Deviation 3.21 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Tip Pinch Strength: Left Hand | 1.70 pounds | Standard Deviation 3.21 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Key Pinch Strength: Right Hand | 1.26 pounds | Standard Deviation 2.99 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 | Change at Month 24, Tip Pinch Strength: Right Hand | 1.46 pounds | Standard Deviation 3.48 |
Comparison: Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.p-value: 0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.p-value: 0.002t-test, 1 sided
Comparison: Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.p-value: 0.001t-test, 1 sided
Comparison: Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.p-value: 0.01t-test, 1 sided
Comparison: Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.p-value: 0.06t-test, 1 sided
Comparison: Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.p-value: 0.177t-test, 1 sided
Comparison: Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.p-value: 0.177t-test, 1 sided
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Flexion: Left Hand | 4.10 degrees | Standard Deviation 10.72 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Flexion: Right Hand | 4.20 degrees | Standard Deviation 10.5 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Extension: Left Hand | 1.83 degrees | Standard Deviation 9.74 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Extension: Right Hand | 2.88 degrees | Standard Deviation 9.98 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Extension: Right Hand | 0.72 degrees | Standard Deviation 13.01 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Flexion: Left Hand | 2.07 degrees | Standard Deviation 10.88 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Extension: Left Hand | -0.32 degrees | Standard Deviation 11.88 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 | Change at Month 24, Flexion: Right Hand | 3.17 degrees | Standard Deviation 9.16 |
Comparison: Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.p-value: 0.054t-test, 1 sided
Comparison: Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.p-value: 0.049t-test, 1 sided
Comparison: Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.p-value: 0.003t-test, 1 sided
Comparison: Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.p-value: 0.781t-test, 1 sided
Comparison: Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.p-value: 0.573t-test, 1 sided
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 | Change at Month 24: Left Hand | -0.52 scores on a scale | Standard Deviation 0.6 |
| Group A: MHGS Grade 4 Hands Group | Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 | Change at Month 24: Right Hand | -0.49 scores on a scale | Standard Deviation 0.64 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 | Change at Month 24: Left Hand | -0.44 scores on a scale | Standard Deviation 0.6 |
| Group B: MHGS Grade 2 or 3 Hands Group | Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 | Change at Month 24: Right Hand | -0.52 scores on a scale | Standard Deviation 0.64 |
Comparison: Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Comparison: Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.p-value: <0.001t-test, 1 sided
Secondary
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
Population: Data were not collected and analyzed for this outcome measure due to change in planned analysis.
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment | 115 Participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment | 118 Participants |
Secondary
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
Population: Data were not collected and analyzed for this outcome measure due to change in planned analysis.
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | 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 | 117 Participants |
| Group B: MHGS Grade 2 or 3 Hands Group | 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 | 104 Participants |
Secondary
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
Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | 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 | 1.5 percentage of subjects |
| Group B: MHGS Grade 2 or 3 Hands Group | 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 | 0 percentage of subjects |