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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160050 / PAS002 |
| Date Original Protocol Accepted |
05/07/2019
|
| Date Current Protocol Accepted |
05/19/2020
|
| Study Name |
Histological and Retrieval Analysis PAS
|
| Device Name |
BARRICAID ANULAR CLOSURE DEVICE (ACD)
|
| Clinical Trial Number(s) |
NCT01283438
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval evaluation is to investigate potential underlying mechanisms that may contribute to endplate lesion (EPL) initiation and/or growth through retrieval analysis and histological analysis of retrieved implants and/or peri-prosthetic tissue. This study is also intended to evaluate causes of device failure (fracture, migration, dissociation and wear particulate). Analysis of tissue and devices/material from retrieved (explanted) Barricaid® ACDs that were originally implanted following discectomy in real-world (i.e., commercial, not clinical study) experience.
|
| Study Population |
All patients implanted with a Barricaid® ACD in the United States.
|
| Sample Size |
This evaluation is not powered to demonstrate statistical conclusions, but rather to gather data for subsequent analysis and surveillance.
|
| Key Study Endpoints |
Histological analysis of tissue and explant material will be assessed per ASTM F561-13.
|
| Follow-up Visits and Length of Follow-up |
This evaluation shall remain in place for 5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
n/a
|
| Actual Number of Sites Enrolled |
n/a
|
| Patient Follow-up Rate |
n/a
|
| Final Safety Findings |
No overt correlation between presence of osteolytic markers with the endplate lesions were found; however, substantive conclusions could not be made due to the limited sample size. Patient population also appeared to experience bony lesions at a lower frequency/distribution than in the RCT used for the PMA.
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| Final Effect Findings |
No effectiveness endpoints in this study.
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| Study Strengths & Weaknesses |
Strength: Provides firsthand clinical information regarding device failures through adjacent tissue and device analysis. Histologic data on retrievals are most translatable to help determine potential mechanism of the bony lesions.
Weakness: Study is reliant on compliance of reporting and returning of explants and associated tissue, so limited data is available.
|
| Recommendations for Labeling Changes |
No definitive conclusions. Labeling change is recommended to document completion of PAS2 when PAS1 is complete and do a final labeling update together.
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