ANESTHESIA/TMJ DISORDERS/FACIAL PAIN

Clinical and Radiologic Follow-Up of

Zimmer Biomet Stock Total
Temporomandibular Joint
Replacement After Surgical
Modifications
Luxiang Zou, DDS,* Luzhu Zhang, DDS, MS,y Dongmei He, DDS, MD,z
Chi Yang, DDS, MD,x Jieyun Zhao, DDS,k and Edward Ellis III, DDS, MS{
Purpose: The aim of this study was to evaluate the clinical and radiologic results of Zimmer Biomet stock
prostheses (Jacksonville, FL) in temporomandibular joint replacement after surgical modifications during
at least 1 year of follow-up.
Patients and Methods: We recruited patients treated by Zimmer Biomet stock prostheses after tech-
nical modifications, including digital templates, autogenous ipsilateral bone grafting from the mandible
to the fossa, salvaging of the disc remnant and suturing it to the medial aspect of the prosthesis, and fat
grafts from a retromandibular incision, between 2010 and 2016. Clinical examination findings including
maximal incisal opening; visual analog scale scores for pain, diet, and mandibular movement; and quality
of life were compared before the operation and at least 1 year postoperatively. The status of the fossa bone
graft was evaluated by computed tomography examination.
Results: The study comprised 38 joints in 33 patients with diagnoses including osteoarthritis, ankylosis,
and neoplasm. Compared with before the operation, maximal incisal opening and visual analog scale

*Resident, Department of Oral Surgery, Ninth People’s Hospital, {Professor, Department of Oral and Maxillofacial Surgery,
Shanghai Jiao Tong University School of Medicine; Shanghai Key University of Texas Health Science Center at San Antonio, San
Laboratory of Stomatology and Shanghai Research Institute of Antonio, TX.
Stomatology; and National Clinical Research Center of Luxiang Zou and Luzhu Zhang contributed equally to this study.
Stomatology, Shanghai, China. This study was supported by grants from the National Natural
yResident, Department of Oral Surgery, Ninth People’s Hospital, Science Foundation of China (81472117), Science and Technology
Shanghai Jiao Tong University School of Medicine; Shanghai Key Commission of Shanghai Municipality Science Research Project
Laboratory of Stomatology and Shanghai Research Institute of (17441900300), eleventh college students innovation training
Stomatology; and National Clinical Research Center of project of Shanghai Jiao Tong University School of Medicine
Stomatology, Shanghai, China. (1117591), and Shanghai Shen Kang Medical Development Fund
zProfessor, Department of Oral Surgery, Ninth People’s Hospital, (16CR3045A).
Shanghai Jiao Tong University School of Medicine; Shanghai Key Conflict of Interest Disclosures: None of the authors have any
Laboratory of Stomatology and Shanghai Research Institute of relevant financial relationship(s) with a commercial interest.
Stomatology; and National Clinical Research Center of Address correspondence and reprint requests to Dr He:
Stomatology, Shanghai, China. Department of Oral Surgery, Shanghai Ninth People’s Hospital,
xProfessor, Department of Oral Surgery, Ninth People’s Hospital, College of Stomatology, Shanghai Jiao Tong University School of
Shanghai Jiao Tong University School of Medicine; Shanghai Key Medicine, 639 Zhi Zao Ju Road, Shanghai, 200011 China; e-mail:
Laboratory of Stomatology and Shanghai Research Institute of [email protected]
Stomatology; and National Clinical Research Center of Received March 12 2018
Stomatology, Shanghai, China. Accepted June 7 2018
kResident, Department of Oral Surgery, Ninth People’s Hospital, Ó 2018 American Association of Oral and Maxillofacial Surgeons
Shanghai Jiao Tong University School of Medicine; Shanghai Key 0278-2391/18/30570-6
Laboratory of Stomatology and Shanghai Research Institute of https://doi.org/10.1016/j.joms.2018.06.013
Stomatology; and National Clinical Research Center of
Stomatology, Shanghai, China.

2518
ZOU ET AL 2519

scores for diet, function, and pain level, as well as the quality-of-life survey score, were considerably
improved during the last follow-up. Computed tomography scans showed all bone grafts were completely
healed within the fossa 1 year after surgery. There was no ectopic bone formation, screw loosening, or
component displacement or breakage.
Conclusions: Our surgical modifications of Zimmer Biomet stock prostheses showed good results for at
least 1 year of follow-up.
Ó 2018 American Association of Oral and Maxillofacial Surgeons
J Oral Maxillofac Surg 76:2518-2524, 2018

Alloplastic temporomandibular joint (TMJ) replacement began to use a modified surgical technique in 2010.
is regarded as the final choice in end-stage joint diseases Patients who were treated by 1 surgeon using methods
such as idiopathic condylar resorption, osteoarthrosis, that we have previously described and referenced7-9
ankylosis, and tumor because it has no risk of absorption and who had at least 1 year of follow-up after the oper-
compared with autogenous bone grafts.1-3 Compared ation (from 2010 to 2016) were recruited into the
with patient-fitted prostheses, stock prostheses require study. If patients did not undergo both clinical and
trimming of the patient’s bone to fit the components computed tomography (CT) examinations before and
during implantation. It is often difficult to place the fossa after the operation, they were excluded. To assess
prosthesis into the concave fossa, especially for fossae stability at 1 year, patients must have had CT scans at
with great depth. Studies have shown that the percent- least at this interval.
age of very concave fossae is 19% among Chinese Preoperatively, CT data of the patient were input in
people and 4% in white people. The mean fossa depth the ProPlan CMF software program (version 1.4;
of Chinese people is 6.8 mm.4,5 Our previous study Materialise NV, Leuven, Belgium) for prosthesis size
has shown that about 40% of Chinese individuals have selection, virtual positioning, and osteotomy planning.
a fossa depth greater than 4.5 mm.6 So, a large volume Digital templates were then designed to guide intrao-
of precious host bone in the eminence must be sacri- perative bone trimming and prosthesis placement.
ficed for those patients, which may affect the retaining The depth of the fossa was measured, and the osteot-
screws in the zygomatic arch and the skull base. Since omy line was designed to cut the bone that overlapped
2010, Yang and colleagues7-9 have proposed several the fossa prosthesis. A bone graft, taken from the bot-
surgical modifications to make prosthesis implantation tom of the articular eminence or the condylar neck,
more straightforward, stable, and accurate. These was used to fill in the fossa and make a flat plane in
technical modifications include 1) transplantation of combination with the residual eminence for the posi-
autogenous bone block grafts harvested from the tioning of the fossa prosthesis. No additional hardware
eminence or ramus stump to the glenoid fossa; 2) was used to secure the bone grafts. Instead of discec-
salvage of TMJ discs; 3) periarticular autogenous fat tomy, routinely performed in conventional TMJ total
grafting through a retromandibular approach; and 4) joint replacement procedures, the discs were
use of computer-aided design–computer-aided salvaged, pushed medial to the condylar prostheses,
manufacturing surgical templates to guide prosthesis and fixed in place by suturing to the surrounding
size selection, bone trimming and grafting, and pros- soft tissues. Subcutaneous free fat was harvested
thesis location. through the retromandibular approach instead of
The aim of this study was to clinically and radiolog- from the commonly used abdominal incision and
ically evaluate the results of implantation of Zimmer was grafted to fill the periprosthetic spaces, in a
Biomet prostheses (Jacksonville, FL) after use of the scarf-like manner surrounding the condylar prosthe-
aforementioned technical modifications at least ses, and then sutured to stay in place.
1 year after surgery.
CLINICAL EVALUATION
Both objective and subjective measurements before
Patients and Methods
surgery, after surgery, and during follow-up visits were
This is a retrospective study that was approved by taken as follows10,11: 1) maximal incisal opening
the local ethics board of the hospital. We followed (MIO); 2) maximal laterotrusion distance; 3) pain
the guidelines of the Declaration of Helsinki in this level, measured on a visual analog scale (VAS) from
study. From 2006 to the end of 2017, 127 patients 0 to 10 (0, no pain; 10, worst pain); 4) jaw function,
(154 joints) underwent implantation of Zimmer measured on a VAS from 0 to 10 (0, normal function;
Biomet stock TMJ prostheses in our department. We 10, no function); 5) diet limitation, measured on a
2520 MODIFICATION OF STOCK PROSTHESIS

<.001
.015
.027
.139

Abbreviations: Ank, ankylosis; Inter, intergroup; MIO, maximal incisal opening; Neo, neoplasm; OA, osteoarthritis; Post, postoperative; Pre, preoperative; QoL, quality of life.
Table 1. DIAGNOSES IN TMJ REPLACEMENT PATIENTS

Value
P
Diagnosis Patients Joints %

13.39  5.29
13.00  6.89
9.50  1.87
Post
TMJ osteoarthritis 19 22 57.89

QoL Score
TMJ ankylosis 8 10 26.32
Neoplasm 6 6 15.79
Osteochondroma 3

19.37  6.07
20.38  6.82
21.50  7.84
Synovial chondromatosis 2

Table 2. COMPARISON OF PREOPERATIVE AND POSTOPERATIVE OUTCOMES IN ANKYLOSIS, OSTEOARTHRITIS, AND NEOPLASM PATIENTS

Pre
Langerhans cell histiocytosis 1
Total 33 38 100

Abbreviation: TMJ, temporomandibular joint.

.012
.015
<.001
.721
Value
P
Zou et al. Modification of Stock Prosthesis. J Oral Maxillofac Surg
2018.

2.18  1.82
2.38  0.74
1.67  1.97
Function Score

Post
VAS from 0 to 10 (0, no restrictions; 10, liquids only);
6) quality of life (QoL) on a questionnaire comprising

4.11  2.75
8.00  1.07
5.17  2.99
8 questions regarding pain, diet and chewing, speech,

Pre
activity, recreation, mood, anxiety, and total evaluation
that were asked based on a 5-point scale (1, excellent;
5, poor), with the total marks calculated and combined

Value

.019
.001
.105
into a score of excellent (8 to 10 marks), good (11 to 14

.01
P
marks), average (15 to 19 marks), or poor ($20
marks)11; and 7) other patients’ complaints such as

2.55  2.15
2.38  1.30
0.67  1.21
facial nerve palsy, lower lip numbness, muscle sore-

Post
ness, joint dysfunction, Frey syndrome, infection, or Diet Score
need for prosthesis removal.

4.89  2.56
6.63  2.07
5.17  2.79
RADIOLOGIC EVALUATION
Pre

CT scans within 1 week after surgery and during

every follow-up were obtained to evaluate the
<.001
.901
.002
.299
Value

following: 1) whether the ramus component was dis-

P

placed or broken; 2) whether the screws were loose

or the surrounding bone was resorbed; 3) the status
1.45  2.01
1.38  1.69
0.17  0.41

of the block bone grafts (displaced, resorbed, or Zou et al. Modification of Stock Prosthesis. J Oral Maxillofac Surg 2018.
Pain Score

Post

healed within the fossa partially or completely

without radiolucent gap); and 4) the presence of
ectopic bone.
4.53  2.93
1.50  2.83
5.50  2.51
Pre

STATISTICAL ANALYSIS
Statistical analysis was carried out using the Statisti-
cal Package for Social Sciences software package,
<.001
<.001
<.001
.404
Value
P

version 13.0 (SPSS, Chicago, IL). The Student paired

t test was used for comparing preoperative and post-
35.26  5.29
32.88  4.49
36.50  4.04

operative significance of MIO, VAS scores, and QoL

Post

scores. Postoperative MIO, VAS scores, and QoL scores

MIO, mm

among osteoarthritis, ankylosis, and neoplasm

patients were compared by 1-way analysis of variance.
26.47  10.72

An a level # .05 was considered significant.

8.63  7.27
25.00  8.72
Pre

Results
A total of 33 patients (38 joints) met the criteria and
Inter

were included in the study. There were 5 men and 28

Neo
Ank
OA

women. Of the patients, 5 had bilateral TMJ prostheses

ZOU ET AL 2521

Table 3. STATUS OF GRAFTED BONE BLOCKS AFTER SURGERY

Bone Block Unhealed Partially Completely No. of Patients

Status Joints Healed Joints Healed Joints With CT Scans

#3 mo 11 — — 10
4-6 mo 1 14 — 13
7-9 mo — 3 — 3
10-12 mo — — — —
$12 mo — — 24 22

Abbreviation: CT, computed tomography.

Zou et al. Modification of Stock Prosthesis. J Oral Maxillofac Surg 2018.

and 28 had unilateral (10 left and 18 right). The felt worse 1 year after the operation. One complained
patients’ ages were between 19 and 84 years, with of muscle discomfort and paroxysmal pain; the other
an average of 51.5 years (standard deviation, was depressed because of TMJ pain on the oper-
12.78 years). The average follow-up period was ated side.
21.48 months (range, 12 to 77 months). The diagnosis Up until each patient’s last visit, no screw loosening,
was osteoarthritis (Wilkes stage IV or V with nonre- bone resorption, component displacement, or ectopic
ducing disc displacement with bone derangements, bone formation was found on the CT scans. Although
ascertained by clinical assessment, magnetic reso- bone grafting was 1 of the 4 technical modifications, it
nance imaging, and surgery) in 19 patients; intra- was not needed for the 8 ankylosis patients (10 joints)
articular TMJ ankylosis in 8 patients; and neoplasm because the fossa had sufficient bone or in 3 patients
in 6 patients, diagnosed by CT and magnetic resonance who had 5 shallow fossa in which the prosthesis could
imaging scans (Table 1). be positioned stably. However, those 11 patients
Compared with before the operation, MIO and VAS underwent the other 3 technical modifications. The
scores for diet, function, and pain level, as well as other 22 patients (23 joints) had bone block grafts
the QoL survey score, were significantly improved harvested from either the articular eminence, condylar
during the last follow-up. There were no significant neck, or coronoid process placed to fill the flat fossa
differences in the postoperative MIO, VAS scores, instead of trimming the adjacent bone. There were
and QoL scores among osteoarthritis, ankylosis, and no bone blocks displaced or resorbed. Around
neoplasm patients (Table 2). Mouth opening limitation 6 months after the operation, the bone block had re-
showed the most improvement in ankylosis patients, modeled and partially healed within the fossa, but after
and pain intensity was improved significantly in 1 year, all of them had completely healed within the
neoplasm and osteoarthritis patients. Neoplasm fossa (Table 3, Fig 1).
patients obtained the most improvement regarding
diet after surgery (87.04%) compared with ankylosis
Discussion
and osteoarthritis patients. Mandibular function
improved similarly in both tumor and ankylosis Alloplastic TMJ replacement has become an
patients (Table 2). Laterotrusion was limited in all increasingly popular alternative to autogenous joint
patients after surgery. In unilateral patients, the post- reconstruction. It has been shown to increase
operative laterotusion toward the ipsilateral side was mandibular motion, reduce pain levels, and improve
4.67  2.43 mm and that toward the contralateral a patient’s QoL.12-14 Compared with custom
side was 1.32  1.45 mm (P < .001). Of the 24 patients devices, which require individual design and
with unilateral prostheses, 5 had contralateral TMJ manufacture, stock prostheses are available in fixed
clicking or hypermobility. In bilateral replacement sizes, which require less preparation time and have
patients, there was nearly no laterotrusion. a lower cost. By using Zimmer Biomet stock
No infection occurred after surgery in any patient. prostheses since 2005 in our department, Yang and
The common complaints during the first 3 months of colleagues have made 4 technical modifications,
follow-up were paresthesia, facial nerve weakness, including digital templates, autogenous ipsilateral
and muscle soreness after speaking or chewing. Frey bone grafting from the mandible to the fossa,
syndrome developed in 1 patient. In most of the pa- salvaging of the disc remnant and suturing it to the
tients who had those symptoms, they went away grad- medial aspect of the prosthesis, and fat grafts from
ually. Only 2 patients with a diagnosis of osteoarthritis a retromandibular incision, since 2010.7-9 Our
2522 MODIFICATION OF STOCK PROSTHESIS

FIGURE 1. Bone graft (arrows) status 1 week (A), 6 months (B), and 12 months (Fig 1 continued on next page.)
Zou et al. Modification of Stock Prosthesis. J Oral Maxillofac Surg 2018.
ZOU ET AL 2523

FIGURE 1 (cont’d). (C) after operation.

Zou et al. Modification of Stock Prosthesis. J Oral Maxillofac Surg 2018.

previous study has shown that the rate of deep fossae to acquire primary stability especially for the
(>4.5 mm) is 33.2% in male and 51.1% in female deep fossa.6
Chinese patients.6 The average fossa depth in Chi- Using the aforementioned technical modifica-
nese people is 6.8 mm. However, there is no report tions, this study showed significant improvement
of fossa depth in white people. To reduce bone trim- in both subjective and objective evaluations before
ming for deep fossa patients, we use bone grafts in and after the operation. The outcome in this study
the fossa instead of bone trimming. The grafted showed better MIO improvement after technique
bone is secured by the fossa prosthesis without the modifications compared with studies by Giannako-
use of hardware. This technique is more straightfor- poulos et al,12 Sanovich et al,13 and Gonzalez-
ward to perform and improves the stability of pros- Perez et al14 and similar results regarding VAS
thesis implantation, as we have previously scores, which used the same evaluation standard.
reported.7-9 After the use of computer-aided design– Although patients lost laterotrusion with the re-
computer-aided manufacturing techniques, the bone placed joint, none reported that it impacted his or
trimming area and the location of the prosthesis her QoL. This may be a result of the alloplastic joint
can be determined accurately. Furthermore, no infe- replacement solving the patient’s main problems,
rior alveolar nerve numbness has occurred using such as pain and mouth opening limitation; in addi-
the described technique. tion, with some degree of hypermobility of the
In this study, CT scans during follow-up periods contralateral-side joint, the movement can be
showed that bone blocks placed in the fossa began compensated for. There were 2 patients diagnosed
to heal within the fossa around 5 to 6 months after sur- with osteoarthritis who felt worse and had
gery; they were completely healed within the fossa at decreased QoL postoperatively: One had long-term
around 12 months. The grafts were stable in the long- muscle discomfort and paroxysmal pain, and the
term without displacement and/or resorption. Instead other was affected by ipsilateral TMJ pain and felt
of bone trimming around the fossa, bone grafts in the depressed. Moreover, on the basis of our clinical
fossa are much more straightforward for the surgeon experience, some of the patients with osteoarthritis
2524 MODIFICATION OF STOCK PROSTHESIS

may be troubled by high expectations regarding the 5. Xu X, Wu J, Zhang J, et al: Measurement and analysis of the
osseous part of the temporomandibular joint. Acta Anat Sin
operation and high pain sensitivity. However, no
17:343, 1986
patient asked for prosthesis removal. 6. Zhang LZ, Meng SS, He DM, et al: Three-dimensional measure-
Furthermore, radiologic follow-up showed no ment and cluster analysis for determining the size ranges of
Chinese temporomandibular joint replacement prosthesis.
screw loosening, component displacement or Medicine (Baltimore) 95:e2897, 2016
breakage, bone resorption, or ectopic bone formation 7. Zhang SY, Liu H, Yang C, et al: Modified surgical techniques for
around the prostheses. Moreover, no infection total alloplastic temporomandibular joint replacement: One
institution’s experience. J Craniomaxillofac Surg 43:934, 2015
occurred and no component removal was necessary 8. Bai G, He D, Yang C, et al: Application of digital templates to guide
in this study. The long-term adverse events were facial total alloplastic joint replacement surgery with Biomet standard
muscular soreness (1 patient), occasional paresthesia replacement system. J Oral Maxillofac Surg 72:2440, 2014
9. Bai G, Yang C, He D, et al: Application of fossa bone graft to
(1 patient), and Frey syndrome (1 patient). Contralat- stabilize stock total joint prosthesis in temporomandibular joint
eral TMJ clicking or hypermobility developed in 6 surgery. J Craniomaxillofac Surg 43:1392, 2015
patients who underwent unilateral joint replacement. 10. Wolford LM, Dingwerth DJ, Talwar RM, Pitta MC: Comparison of
2 temporomandibular joint total joint prosthesis systems. J Oral
Some studies have shown the kinematic differences Maxillofac Surg 61:685, 2003
between natural and alloplastic joints.15-17 Lack of 11. Dimitroulis G, McCullough M, Morrison W: Quality-of-life sur-
lateral pterygoid muscle attachment and the hinge vey comparing patients before and after discectomy of the
temporomandibular joint. J Oral Maxillofac Surg 68:101,
prosthesis design may cause the nonreconstructed
2010
joint to alter its movement, and this could aggravate 12. Giannakopoulos HE, Sinn DP, Quinn PD: Biomet Microfixation
the natural joint’s load. temporomandibular joint replacement system: A 3-year follow-
up study of patients treated during 1995 to 2005. J Oral Maxillo-
Alloplastic joint replacement has been successfully fac Surg 70:787, 2012
used for nearly 30 years, but the number of docu- 13. Sanovich R, Mehta U, Abramowicz S, et al: Total alloplastic
mented cases is only 1,262.18 This 1-year follow-up temporomandibular joint reconstruction using Biomet stock
prostheses: The University of Florida experience. Int J Oral
study of technical modifications of Zimmer Biomet Max Surg 43:1091, 2014
stock prostheses showed good results. Studies with 14. Gonzalez-Perez LM, Fakih-Gomez N, Gonzalez-Perez-Somarriba B,
larger sample sizes and longer follow-up periods are et al: Two-year prospective study of outcomes following total
temporomandibular joint replacement. Int J Oral Maxillofac
still needed in the future. Surg 45:78, 2016
15. Leiggener CS, Erni S, Gallo LM: Novel approach to the study of
jaw kinematics in an alloplastic TMJ reconstruction. Int J Oral
Maxillofac Surg 41:1041, 2012
References 16. Ramos AM, Mesnard M: The stock alloplastic temporomandib-
ular joint implant can influence the behavior of the opposite
1. Imola MJ, Liddell A: Temporomandibular joint reconstruction. native joint: A numerical study. J Craniomaxillofac Surg 43:
Curr Opin Otolaryngol Head Neck Surg 24:336, 2016 1384, 2015
2. Mercuri LG, Edibam NR, Giobbie-Hurder A: Fourteen-year 17. Wojczynska A, Leiggener CS, Bredell M, et al: Alloplastic
follow-up of a patient-fitted total temporomandibular joint total temporomandibular joint replacements: Do they
reconstruction system. J Oral Maxillofac Surg 65:1140, 2007 perform like natural joints? Prospective cohort study with
3. Guarda-Nardini L, Manfredini D, Ferronato G: Temporomandib- a historical control. Int J Oral Maxillofac Surg 45:1213,
ular joint total replacement prosthesis: Current knowledge 2016
and considerations for the future. Int J Oral Maxillofac Surg 18. Zou L, He D, Ellis E: A comparison of clinical follow-up of
37:103, 2008 different total temporomandibular joint replacement prosthe-
4. Xu X, Feng G, Zhang J, et al: Osseous morphology of the tempo- ses: A systematic review and meta-analysis. J Oral Maxillofac
romandibular joint. Chin J Anat 9:38, 1986 Surg 76:294, 2018