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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Grade 4 Hands" group | Experimental | "Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period. |
|
| "Grade 2 or 3 Hands" group | Experimental | "Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse injectable implant and 2% lidocaine HCL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 24 |
| Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site #0010393 | Sacramento | California | United States | |||
| Merz Investigative Site #0010321 |
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A total of 256 subjects were enrolled and treated, out of which 216 subjects completed the study.
The study was conducted at 9 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: MHGS Grade 4 Hands Group | Subjects with Merz hand grading scale (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 percent (%) lidocaine hydrochloric acid (HCL) up to 3 cubic centimeter (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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety evaluation set (SES) was the subset of all subjects who were exposed to the study device at enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The SES was the subset of all subjects who were exposed to the study device at enrollment. | Posted | Number | percentage of subjects | Month 6 |
|
Baseline up to Month 24
The investigator asked the subject for adverse events (AEs) systematically at each visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2017 | Dec 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2019 | Dec 10, 2019 | SAP_001.pdf |
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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. |
| 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. | 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. | 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. | 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). | 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). | 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). | 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). | Months 9, 15, and 21 |
| San Diego |
| California |
| United States |
| Merz Investigative Site #0010358 | Vista | California | United States |
| Merz Investigative Site #0010099 | 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 |
| Lost to Follow-up |
|
| Non-compliant |
|
| Sponsor instructed |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fitzpatrick skin type | Skin type I = white; very fair, red or blonde hair blue eyes; freckles; always burns, never tans, skin type II = white, fair, red or blond hair; blue, hazel or green eyes; usually burns, tans with difficulty, skin type III = cream white; fair with any eye or hair color (common); sometimes mild burn, gradually tans, skin type IV = brown; typical Mediterranean Caucasian skin; rarely burns, tans with ease, skin type V = dark brown; mid-eastern skin types; very rarely burns, tans easily, and skin type VI = black; never burns, tans very easily. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | The SES was the subset of all subjects who were exposed to the study device at enrollment. | Posted | Number | percentage of subjects | Month 24 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | degrees | Baseline, Month 24 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | Baseline, Month 24 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Month 24 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | pounds | Baseline, Month 24 |
|
|
|
|
| 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). | The SES was the subset of all subjects who were exposed to the study device at enrollment. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 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). | Data were not collected and analyzed for this outcome measure due to change in planned analysis. | Posted | Months 9, 15, and 21 |
|
|
| 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). | The SES was the subset of all subjects who were exposed to the study device at enrollment. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 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). | Data were not collected and analyzed for this outcome measure due to change in planned analysis. | Posted | Months 9, 15, and 21 |
|
|
| 1 |
| 130 |
| 9 |
| 130 |
| 70 |
| 130 |
| EG001 | 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. | 0 | 126 | 3 | 126 | 57 | 126 |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (21.0) | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Sarcoma excision | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Nodule | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| Change at Month 24, Extension: Left Hand |
|
| Change at Month 24, Extension: Right Hand |
|
| t-test, 1 sided |
| <.001 |
| Other |
| Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | .054 | Other |
| Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | .049 | Other |
| Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | .003 | Other |
| Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | .781 | Other |
| Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | .573 | Other |
| t-test, 1 sided |
| <.001 |
| Other |
| Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| t-test, 1 sided |
| <.001 |
| Other |
| Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| Change at Month 24, Tip Pinch Strength: Left Hand |
|
| Change at Month 24, Tip Pinch Strength: Right Hand |
|
| Change at Month 24, Key Pinch Strength: Left Hand |
|
| Change at Month 24, Key Pinch Strength: Right Hand |
|
| Change at Month 24,Palmar Pinch Strength:Left Hand |
|
| Change at Month 24,PalmarPinch Strength:Right Hand |
|
| t-test, 1 sided |
| .001 |
| Other |
| Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24. | t-test, 1 sided | <.001 | Other |
| Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24. | t-test, 1 sided | .002 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | .001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | <.001 | Other |
| 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. | t-test, 1 sided | .010 | Other |
| 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. | t-test, 1 sided | .060 | Other |
| 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. | t-test, 1 sided | .177 | Other |
| 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. | t-test, 1 sided | .177 | Other |