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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060023 / PAS002 |
| Date Original Protocol Accepted |
05/12/2009
|
| Date Current Protocol Accepted |
05/12/2009
|
| Study Name |
Enhanced Surveillance
|
| Device Name |
BRYAN CERVICAL DISC PROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Sponsor collects the information for any adverse events and complaints, including those which are not associated with any adverse clinical effect, received by the company for the BRYAN device following PMA approval.
|
| Study Population |
Study population is as per device indication.This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy.
|
| Sample Size |
NA
|
| Key Study Endpoints |
The primary outcome variable, overall success, is defined below. A patient will be considered an overall success if all of the following conditions are met:
- Postoperative Neck Disability Index score improvement of at least 15-points from preoperative (score decrease signifies improvement);
- Maintenance or improvement in neurological status from preoperative;
- No serious adverse event classified as implant associated or implant/surgical procedure associated; and
- No additional surgical procedure classified as a "failure". Second surgery "failures" are additional surgeries that occur after the treatment surgery that affect the original device configuration.
|
| Follow-up Visits and Length of Follow-up |
There is no follow-up of subjects. The study reporting occurs at six-month intervals for the first two years of approval and then continues on an annual basis until five years after PMA approval.
|
| Interim or Final Data Summary |
| Interim Results |
This ESS report covers the period from October 16, 2009 to April 12, 2010. No complaints and adverse events were reported for the BRYAN Cervical Disc or the instruments used with the implants in the US during the covered period. A total of 4 devices have been sold during this time period. There were 7 outside of the US complaints and adverse events recorded for the BRYAN Cervical Disc implants during the time period from October 16, 2009 to April 12, 2010. Two events were related to a revision surgery due to postoperative pain. one evet was related to a revision surgery following osteolysis and a low grade infection. One event was related to a revision surgery following formation of posterior osteophytes. Two events related to the device, which were reported that the Bryan Disc made a cracking noise when a surgeon moved the implants between his thumb and index finger. These two devices were not used to treat the 2 patients and no complications were reported. The last patient had been reported by the surgeon that there were bubbles coming from the Bryan Disc before implanting into the patient due to the torn sheath. Another implant was used to treat patient and no complications were reported.
|
| Actual Number of Patients Enrolled |
N/A - enhanced surveillance stud
N/A - enhanced surveillance study
|
| Actual Number of Sites Enrolled |
N/A - enhanced surveillance study
|
| Patient Follow-up Rate |
Not applicable enhanced surveillance study
The study duration was 5 years.
|
| Final Safety Findings |
A cumulative total of 1950* implants have been sold in the U.S. since the PMA approval date of May 12,
2009 to March 11, 2014. A cumulative total of twenty five MDRs have been reported for implants sold in the U.S. since the approval date to March 11, 2014. A cumulative total of twenty MDRs have been reported for instruments sold in the U.S. since the approval date. A cumulative total of 7769 implants have been sold outside of the U.S. since the PMA approval date of May 12, 2009 to March 11, 2014. A cumulative total of 86 MDRs have been reported for implants sold outside of the U.S. since the approval date to March 11, 2014.
|
| Final Effect Findings |
N/A
|
| Study Strengths & Weaknesses |
The study permitted monitoring of the AEs occurrence in the broader population of the device users.
Due to the study design it is impossible to meaningfully evaluate the AEs rates. Further, due to study design and lack of clinical information reported to the company it is difficult to find any particular trends in occurrence of heterotopic ossification and osteolysis.
|
| Recommendations for Labeling Changes |
Yes
Bryan Cervical Disc implantation associated with higher level of surrounding tissue dissection than other artificial disc systems currently on the market. This in turn leads to higher incidents of HO. The HO incidents were observed in the ESS study.
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