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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050052 S049/ PAS001 |
| Date Original Protocol Accepted |
09/02/2015
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| Date Current Protocol Accepted |
04/26/2017
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| Study Name |
Radiesse Radiological Evaluation Study
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| Device Name |
RADIESSE INJECTABLE IMPLANT
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a 2-year, prospective, open-label, new enrollment PAS evaluating the radiographic appearance of Radiesse implantation in the dorsum of the hands.
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| Study Population |
Adults who are at least 22 years old with hands rated as MHGS 2, 3, or 4 at baseline. There is no comparison group in this study.
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| Sample Size |
Twenty subjects (10 subjects with MHGS 4 and 10 subjects with MHGS 2 or 3) will be enrolled at 1 site in the U.S. The sample size is not based on power calculations for a formal statistical hypothesis test, but rather is based on a clinically relevant sample of subjects that will provide a degree of characterization regarding the ability to perform radiologic evaluations after treatment with Radiesse.
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| Key Study Endpoints |
The main study endpoint is the incidence of obscuration of the bones of the hand at 1-, 6-, 12-, and 24-months following injection of Radiesse in the dorsum of the hand. Other safety endpoints include: hand function testing and MHQ; incidence of device/injection-related severe AEs; and incidence of all AEs. Secondary effectiveness endpoints include MHGS ratings by a masked evaluator and subject-reported GAIS score.
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| Follow-up Visits and Length of Follow-up |
2 years
Follow-up in-clinic visits at months 1, 6, 12, 18, and 24. If repeat injections are administered at any of the 6-, 12-, or 18-month visits, subjects will receive a 72-hour phone call following each injection and return for follow-up visits 1 month post-injection at months 7, 13, and/or
19 respectively.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
20 subjects (40 hands)
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| Actual Number of Sites Enrolled |
One
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| Patient Follow-up Rate |
Over the course of the postoperative follow-up, 90% - 100% accountability was achieved at all scheduled visits through Month 24.
Time Point
Subjects Seen – Total [n (%)]
Baseline X-Ray
20 (100%)
Baseline Treatment
20 (100%)
Month 1 X-Ray
20 (100%)
Month 1 Visit
20 (100%)
Month 6 X-Ray
20 (100%)
Month 6 Follow-Up
20 (100%)
Month 12 Follow-Up
20 (100%)
Month 24 X-Ray*
6 (100.0%)
Month 24 Follow-Up
20 (100.0%)
(* Visit required only if
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| Final Safety Findings |
As expected, over 80% of the subjects had foreign material (the Radiesse implant) present throughout 24 months of study period. Regarding the primary endpoint, no X-ray obscuring of bones were found at any of the evaluated time points.
The most common treatment related AEs were “General disorders and administration site conditions” (the majority is swelling) and “Injury, poisoning and procedural complications”. Reported AEs are mostly mild or moderate in severity and did not last more than 30 days. Over the course of the study, 30% of the AEs were considered as possibly/definitely related to the treatment/device. There were two physician-reported severe AEs (administration site condition – swelling in both hands of one subject) to be related to the treatment.
No death or serious AEs were reported and no subject withdrew due to an AE.
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| Final Effect Findings |
Majority of subjects (80%) showed some improvements on GAIS from baseline to postoperative up to 24mon. The proportion of subjects with improvements is higher in group B (90%) than in group A (70%). The observed difference may be attributed to the age, and severity of loss of fatty tissue. Majority of subjects (65%) showed sustained improvements (>= 1point) on the scores MHGS from baseline to postoperative 24m. The proportion of subjects with improvements in group A is 80%, and in group B is 50%.
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| Study Strengths & Weaknesses |
Strengths: The study findings provide information on the long-term safety and effectiveness (i.e. 24 months) of the device stratified by MHGS. The study is completed on time with an overall follow- up rate greater that 90%.
Weakness: The study only enrolled one study site with 20 subjects (40 hands) by protocol. All enrolled subjects are females, with 95% of subjects being White Caucasian. Therefore, the study findings may not represent a diverse group of surgeons and diverse patient populations.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the 24-months long term results from the post-approval study. In addition, labeling change is recommended to report the adverse event profile by severity loss of fatty tissue (i.e. MHGS 2&3 vs. MHGS 4). The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow up visits etc.), results and study strengths and limitations.
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