|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS110004 / PSS002 |
| Date Original Plan Accepted |
01/20/2012
|
| Date Current Plan Accepted |
11/25/2013
|
| Study Name |
Explant
|
| Device Name |
Total temporomandibular joint replacement system
|
| Root Document Number |
P020016
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
"This is a study of retrieved explants based on the number of revision cases for which explants are retrieved. This study will evaluate explants retrieved through:
1. a prospective, multi-center trial that enrolls subjects who previously received a Biomet TMJ Replacement System (Study A, PS110004) and who are undergoing a revision procedure;
2. an analysis of explants returned to Biomet through the complaint handling process
3. explants received from all revisions which occur during the survival study (PS110004A) at sites enrolled in the survival study, whether or not revisions came from the survival analysis.
"
|
| Study Population |
18 to 21 yrs; Adult 21+
|
| Sample Size |
20 explanted joints
|
| Key Study Endpoints |
The study endpoints will include analysis of the modes and causes of failure. The potential effect of a subject¿s demographic data, clinical history, or diagnosis on device failure will also be performed.
|
| Follow-up Visits and Length of Follow-up |
Not applicable
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
40 explanted joints
|
| Actual Number of Sites Enrolled |
8
|
| Patient Followup Rate |
100%
|
| Final Safety Findings |
The majority of the enrolled joints (65%, 26/40) had a Biologic Cause of Failure, indicating these joints were removed for biologic reasons such as re-ankylosis and infection.
Only 12.5% of explants (5/40) were determined to have a Probable Mode of Failure. The most probable reasons leading to mechanical failure of these devices were related to improper surgical technique (n=4) or trauma resulting in a failure of the device secondary to the impact (n=1). There were no evidence or trends found that suggested a failure of the implant materials when used appropriately and when subject to typical loads over a period of time.
The most common Biologic Cause of Failure was: bone formation with ankylosis which was consistent with the preoperative diagnosis in these patients.
The majority of the enrolled joints (72.5%, 29/40) had no Mode of Failure, indicating there was no mechanical issue with the Biomet TMJ Replacement Device that led to its explanation.
|
| Final Effectiveness Findings |
The mean time to revision for these cases was 5.0 ± 4.4 years.
Preoperative diagnoses that were found to lead to a shorter time to revision included arthritis and ankylosis. In both diagnoses, the mean time to revision was more than 13 years. These results are consistent with those reported in PS110004A-Time to revision.
|
| Study Strengths and Weaknesses |
Strengths: Large sample size, long follow-up period, high follow-up rate. Weaknesses: Limited information available, such as oxidation measurements, radiographs and pathology.
|
| Recommendations for Labeling Changes |
Label to be updated with the explant analysis results
|
