Radiesse® Safety Study For the Treatment of Hands

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-10

Study Completion Date

2019-01-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Volume Loss in the Dorsum of the Hand

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Radiesse injectable implant and 2% lidocaine HCL

Intervention Type 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.

"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.

Group Type EXPERIMENTAL

Radiesse injectable implant and 2% lidocaine HCL

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
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.
4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.

Exclusion Criteria

1. Was a participant in the Radiesse hands pre-market clinical study
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 AEs.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes