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Completed

NCT Number: NCT02949921

Radiological Evaluation of Radiesse Implantation in the Hands

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.

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Key information

Conditions

Volume Loss in the Dorsum of the Hand

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigative Site #0010358

Vista, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1

    Time frame: 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.

  2. Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6

    Time frame: 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.

  3. Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12

    Time frame: 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.

  4. Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6

    Time frame: Months 1 and 6

  2. Michigan Hand Outcomes Questionnaire (MHQ) Scores

    Time frame: Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24

    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.

  3. 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

    Time frame: 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).

  4. Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12

    Time frame: 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).

  5. Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6

    Time frame: 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).

  6. Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2016
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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