Radiological Evaluation of Radiesse Implantation in the Hands
NCT ID: NCT02949921
Last Updated: 2023-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-12-01
2018-01-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"Grade 4 Hands" group
"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.
Radiesse injectable implant and 2% lidocaine HCL
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.
"Grade 2 or 3 Hands" group
"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.
Radiesse injectable implant and 2% lidocaine HCL
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.
Interventions
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Radiesse injectable implant and 2% lidocaine HCL
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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 adverse events (AEs).
22 Years
ALL
Yes
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Kreymerman, MD,FACS
Role: STUDY_DIRECTOR
Study Director
Locations
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Merz Investigative Site #0010358
Vista, California, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P151010, M900311003
Identifier Type: -
Identifier Source: org_study_id