Contraindications
The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System should not be used for patients with one or
more of the following conditions:
- Active or suspected infections in or about the implantation site
- Uncontrollable masticatory muscle hyperfunction (clenching or grinding) which may lead to overload and loosening
of screws
- Known allergy to any of the component materials
Clinical data
A total of 279 patients (465 joints) were enrolled in a post-approval study in which clinical data was collected
both pre-operatively (month 0) and post-operatively at various follow-up intervals out to 5 years (month 60). Based
on previous clinical studies of TMJ patients, it was anticipated that a large number would become lost to follow-up.
It was desired to have a cohort of at least 100 patients remaining at the 5-year evaluation time point, therefore a
significantly larger number of patients were enrolled in the study. Clinical data was obtained out to 5 years on a
final cohort of 128 patients (204 joints). Pre-operative data and post-operative follow-up data were collected using
a standardized data collection format. Subjective data related to pain, function of the lower jaw, and diet were
obtained using a 55mm length visual analogue scale. The pain scale ranged from "no pain" at 0mm to "severest pain"
at 55mm. The function scale ranged from "no loss" at 0mm to "cannot function" at 55mm. The diet scale ranged from
"no restriction" at 0mm to "liquids only" at 55mm. Subjective data was also collected by asking each patient how
their current quality of life compared to before they received their TMJ implants. Objective measurements of
mandibular range of motion were made directly on the patients. These measurements, recorded in millimeters, included
maximum interincisal opening and left and right excursion. Results are shown for only the month 0 and month 60
evaluation time points as clinical data was not available for each patient at every intermediate follow-up interval.
These clinical data show a statistically significant decrease in pain, increase in function, decrease in diet
restrictions, and increase in maximum interincisal opening. A summary of the quality of life responses at month 60
is also shown.
Pain Measurement Improvement at 5 Years
(scale: 0mm = "no pain" to 55mm = "severest pain")
| Month |
Mean (mm) |
S.D. (mm) |
| 0 |
39.0 |
13.4 |
| 60 |
18.3 |
15.9 |
Function Measurement Improvement at 5 Years
(scale: 0mm = "no loss" to 55mm = "cannot function")
| Month |
Mean (mm) |
S.D. (mm) |
| 0 |
36.4 |
13.0 |
| 60 |
17.9 |
13.8 |
Diet Measurement Improvement at 5 Years
(scale: 0mm = "no restriction" to 55mm = "liquids only")
| Month |
Mean (mm) |
S.D. (mm) |
| 0 |
32.4 |
14.2 |
| 60 |
14.7 |
13.4 |
MIO Measurement Increase at 5 Years
| Month |
Mean (mm) |
S.D. (mm) |
| 0 |
25.0 |
11.2 |
| 60 |
33.4 |
9.2 |
Summary of Quality of Life Responses at 5 Years
How does your current quality of life compare to before you received your TMJ implants?
| Response |
Percentage of Patients |
| Much Better |
52.3% |
| Better |
25.8% |
| Same |
7.8% |
| Worse |
12.5% |
| Much Worse |
1.6% |
Several of the patients enrolled in the post-approval study that were not included in the final cohort of 128
patients had adverse events reported prior to their becoming lost to follow up or being removed from
the study for another reason. The adverse event data presented below includes events reported for any of the 279
initially enrolled patients.
These types of adverse events and the rate at which they occurred as well as the quality of life responses shown
above are not unexpected in this compromised patient population with many previous surgeries involving failed tissue
grafts and/or failed implants from other manufacturers which may leave behind material particulates.
Adverse Events Resulting in Additional Surgery
| Category |
Patients (n=279) |
Joints (n=465) |
|
No. |
% |
No. |
% |
|
Chronic or recurring pain and/or swelling
|
4 |
1.4% |
4 |
0.9% |
|
Infection
|
3 |
1.1% |
3 |
0.6% |
|
Dislocation of implant components
|
2 |
0.7% |
3 |
0.6% |
|
Performation or dehiscence of surrounding tissues
|
2 |
0.7% |
2 |
0.4% |
|
Loosening
|
2 |
0.7% |
2 |
0.4% |
|
Material sensitivity (reaction to implant components)
|
1 |
0.4% |
2 |
0.4% |
|
Malocclusion
|
1 |
0.4% |
1 |
0.2% |
|
Total
|
15 |
5.4% |
17 |
3.7% |