Radiological Evaluation of Radiesse Implantation in the Hands

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Radiesse® Post Approval Safety Study - Radiological Evaluation of Implantation in the Hands

Conditions
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Volume Loss in the Dorsum of the Hand

Intervention / Treatment
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* Device: Radiesse injectable implant and 2% lidocaine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator. Is at least 22 years of age. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study. Exclusion Criteria: Was a participant in the Radiesse hands pre-market clinical study. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grade 4 Hands group<br>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. | Device: Radiesse injectable implant and 2% lidocaine HCL<br>* 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.<br>|
| Experimental: Grade 2 or 3 Hands group<br>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. | Device: Radiesse injectable implant and 2% lidocaine HCL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |