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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).
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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 |
|---|---|---|
| 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. | 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. | 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. | 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. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kreymerman, MD,FACS | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site #0010358 | Vista | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36573029 | Background | Moradi A, Ethakovic R, Odena G. Aesthetic Implantation of Calcium Hydroxylapatite Does Not Interfere With Radiological Assessment of Bones in the Dorsum of the Hands. Aesthet Surg J. 2023 May 15;43(6):696-703. doi: 10.1093/asj/sjac344. |
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A total of 20 participants were enrolled, treated, and completed the study.
The study was conducted at 1 investigative site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: MHGS Grade 4 Hands Group | Participants 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. |
| FG001 | Group B: MHGS Grade 2 or 3 Hands Group | Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: MHGS Grade 4 Hands Group | Participants 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants 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, Continuous | Mean |
| 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 | 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. | All participants who were enrolled in the study. | Posted | Number | participants | Month 1 |
|
Baseline up to Month 24
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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| 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 | Participants 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nodule | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.de |
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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 | Dec 13, 2016 | Dec 27, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2017 | Dec 27, 2018 | SAP_000.pdf |
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| 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). | 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). | 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). | 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). | Months 7 and 12 |
| BG001 | Group B: MHGS Grade 2 or 3 Hands Group | Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. |
|
|
| Primary | 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. | All participants who were enrolled in the study. | Posted | Number | participants | Month 6 |
|
|
|
| Primary | 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. | Data was not calculated since no participant had bone obscuration at Month 6, and therefore no x-ray was taken at Month 12. | Posted | Month 12 |
|
|
| Primary | 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. | Participants who received 4 treatments in total (initial and 3 retreatments). | Posted | Number | participants | Month 24 |
|
|
|
| Secondary | Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | All participants who were enrolled in the study. | Posted | Number | percentage of participants | Months 1 and 6 |
|
|
|
| Secondary | 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. | All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24 |
|
|
|
| Secondary | 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). | All participants who were enrolled in the study. | Posted | Number | participants | Months 1 and 6 |
|
|
|
| Secondary | 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). | All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment. | Posted | Number | participants | Months 7 and 12 |
|
|
|
| Secondary | 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). | All participants who were enrolled in the study. | Posted | Number | percentage of participants | Months 1 and 6 |
|
|
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| Secondary | 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). | All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment. | Posted | Number | percentage of participants | Months 7 and 12 |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Group B: MHGS Grade 2 or 3 Hands Group | Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately 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 on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. | 0 | 10 | 0 | 10 | 8 | 10 |
| Pain | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Herpes zoster | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Animal scratch | Injury, poisoning and procedural complications | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dental implantation | Surgical and medical procedures | Systematic Assessment |
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| Oral surgery | Surgical and medical procedures | Systematic Assessment |
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| Rotator cuff repair | Surgical and medical procedures | 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.
| Baseline: Left Hand (Pain) |
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| Baseline: Right Hand (Function) |
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| Baseline: Right Hand (Pain) |
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| Month 1: Left Hand (Function) |
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| Month 1: Left Hand (Pain) |
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| Month 1: Right Hand (Function) |
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| Month 1: Right Hand (Pain) |
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| Month 6: Left Hand (Function) |
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| Month 6: Left Hand (Pain) |
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| Month 6: Right Hand (Function) |
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| Month 6: Right Hand (Pain) |
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| Month 7: Left Hand (Function) |
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| Month 7: Left Hand (Pain) |
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| Month 7: Right Hand (Function) |
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| Month 7: Right Hand (Pain) |
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| Month 12: Left Hand (Function) |
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| Month 12: Left Hand (Pain) |
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| Month 12: Right Hand (Function) |
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| Month 12: Right Hand (Pain) |
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| Month 13: Left Hand (Function) |
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| Month 13: Left Hand (Pain) |
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| Month 13: Right Hand (Function) |
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| Month 13: Right Hand (Pain) |
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| Month 18: Left Hand (Function) |
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| Month 18: Left Hand (Pain) |
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| Month 18: Right Hand (Function) |
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| Month 18: Right Hand (Pain) |
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| Month 19: Left Hand (Function) |
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| Month 19: Left Hand (Pain) |
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| Month 19: Right Hand (Function) |
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| Month 19: Right Hand (Pain) |
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| Month 24: Left Hand (Function) |
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| Month 24: Left Hand (Pain) |
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| Month 24: Right Hand (Function) |
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| Month 24: Right Hand (Pain) |
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| Month 1: Left hand (much improved) |
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| Month 1: Right hand (much improved) |
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| Month 1: Left hand (improved) |
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| Month 1: Right hand (improved) |
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| Month 1: Left hand (no change) |
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| Month 1: Right hand (no change) |
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| Month 1: Left hand (worse) |
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| Month 1: Right hand (worse) |
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| Month 1: Left hand (much worse) |
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| Month 1: Right hand (much worse) |
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| Month 1: Left hand (very much worse) |
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| Month 1: Right hand (very much worse) |
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| Month 6: Left hand (very much improved) |
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| Month 6: Right hand (very much improved) |
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| Month 6: Left hand (much improved) |
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| Month 6: Right hand (much improved) |
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| Month 6: Left hand (improved) |
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| Month 6: Right hand (improved) |
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| Month 6: Left hand (no change) |
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| Month 6: Right hand (no change) |
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| Month 6: Left hand (worse) |
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| Month 6: Right hand (worse) |
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| Month 6: Left hand (much worse) |
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| Month 6: Right hand (much worse) |
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| Month 6: Left hand (very much worse) |
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| Month 6: Right hand (very much worse) |
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| Month 7: Left hand (much improved) |
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| Month 7: Right hand (much improved) |
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| Month 7: Left hand (improved) |
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| Month 7: Right hand (improved) |
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| Month 7: Left hand (no change) |
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| Month 7: Right hand (no change) |
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| Month 7: Left hand (worse) |
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| Month 7: Right hand (worse) |
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| Month 7: Left hand (much worse) |
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| Month 7: Right hand (much worse) |
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| Month 7: Left hand (very much worse) |
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| Month 7: Right hand (very much worse) |
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| Month 12: Left hand (very much improved) |
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| Month 12: Right hand (very much improved) |
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| Month 12: Left hand (much improved) |
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| Month 12: Right hand (much improved) |
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| Month 12: Left hand (improved) |
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| Month 12: Right hand (improved) |
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| Month 12: Left hand (no change) |
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| Month 12: Right hand (no change) |
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| Month 12: Left hand (worse) |
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| Month 12: Right hand (worse) |
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| Month 12: Left hand (much worse) |
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| Month 12: Right hand (much worse) |
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| Month 12: Left hand (very much worse) |
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| Month 12: Right hand (very much worse) |
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