Total prosthetic replacement of the TMJ: experience with two systems 1988-1997

Consultant Oral and Maxillo facial Surgeon; ** Chief Maxillofacial Technologist, City Hospital NHS Trust, Birmingham; * Consultant Oral and Maxillo facial Surgeon, Gloucestershire Royal Hospital, Gloucester, UK

SUMMARY

We report our experience with the Vitek VK II and the Christensen systems for total prosthetic replacement of the temporomandibular joint, in 62 patients treated between 1988 and 1997. Thirteen were treated in Birmingham and 49 in Gloucester. A total of 86 joints were replaced, of which 27 (31%) were Vitek VK II and 59 (69%) were Christensen prostheses. Just over half of the patients were treated for degenerative arthropathy or osteoarthritis, and the second most common diagnosis was rheumatoid arthritis. Twenty-five patients had had previous operations. The median follow-up was 14.5 months (range 1-120). Preoperatively only 14 patients (23%) could eat all types of food - and postoperatively this increased to 48 (77%). Thirty-nine patients (63%) reported severe pain preoperatively compared with three (5%) postoperatively. No prostheses were rejected, but four patients required replacement of Vitek VK II by Christensen prostheses; all four showed histological evidence of a foreign body giant cell reaction. The overall success rate was 58/62 patients and 81/86 joints replaced (94% in each case). However, for the Vitek VK II system alone the success rate was 14/17 patients (82%) and 24/27 joints replaced (89%).

INTRODUCTION

Total replacement of the temporomandibular joint (TMJ) may be indicated for severe pain, or restricted mouth opening, or both. In practice, the disorders for which it may be considered include mainly osteoarthritis (stages IV and V in the classification of the American Society of Temporomandibular Joint Surgeons¹), rheumatoid arthritis, psoriaratic arthritis, ankylosis after injury or infection, and (occasionally) reconstruction after excision of a tumour. In younger patients, the costochondral rib graft is an accepted technique for reconstruction after injury, infection, tumours, or for developmental deformity. When the TMJ is affected by an arthropathy, a rib graft may be less suitable. Long-term treatment with steroids may reduce the physical strength of the rib, and there is a risk of further fibrosis and even ankylosis.^2,3 In addition, the rib graft often sits lateral to the ramus and can be difficult to locate precisely in the glenoid fossa. For these reasons, alloplastic materials have been developed for total prosthetic replacement of the TMJ.

Experience with alloplastic materials for reconstruction of the TMJ began in 1934 when Risdon used gold foil in the fossa to prevent re-ankylosis.⁴ Other metals implanted in the fossa have included tantalum foil,⁵ stainless steel,⁶ and cobalt-chromium alloy (Vitallium) as in the cast prosthesis devised by Christensen.⁷ Table 1 lists various alloplastic TMJ prostheses that were developed and used between 1963 and 1995.^7-34 A total TMJ prosthesis (fossa and condyle) was not described until 1974,¹⁶ and then in only one case. Until then, surgeons had concentrated on implanting either a fossa or a condylar head, but not both. Of the two systems reported here, the Vitek VK II system was not described as a total joint system until 1983, and the Christensen system until 1995 (although it had been developed over the preceding 25 years).

There has been a variable success rate for TMJ prostheses, ranging from 60% to 100%, and this degree of variability is still being reported. Some reports include few cases or short follow-up periods or both. In some, 'success' is calculated in terms of patients rather than prostheses; indeed 'success' and 'failure' are not always clearly defined and may mean different things to different authors. We know of few comparative studies and no randomized trials.

During the late 1980s and early 1990s, it became apparent that certain materials being implanted into the TMJ were not biocompatible.³⁶ Some of the worst problems were associated with Teflon ® fluorinated ethylene propylene (FEP) which had been used in the Proplast ® TMJ interpositional implant and the VKI Teflon FEP fossa prosthesis. Failure of implants became such a problem that the manufacturer (Vitek) Filed for voluntary bankruptcy in 1990. Subsequently in 1993 Dow Corning voluntarily suspended the sale of Silastic products for reconstruction of TMJs and Osteomed and Techmedica both halted the sale of their TMJ systems. The Teflon FEP fossa prosthesis originally introduced by Vitek in 1982 was replaced by one made of ultra high molecular weight polyethylene (UPE) in 1986. No Teflon FEP fossae were used in this present study. We report here our experience with the VK II (designed by Kent et al.) and the Christensen total prosthetic TMJ systems at two centres in the UK over a 1O-year period from 1988 to 1997.

PATIENTS AND METHODS

We studied 62 patients who required total prosthetic replacement of the TMJ in Birmingham (n=l3) and Gloucester (n=49) from 1988 to 1997 inclusive. The following were recorded: provisional and clinical details; diagnosis; number of previous operations: width of mouth opening: visual analogue scale (VAS) rating of pain, and VAS rating of difficulty in eating before and after operation: results of radiology and imaging investigations; and anaesthetic assessment.

TECHNIQUE

In Birmingham, a preauricular approach was combined with an incision over the ramus of the mandible just above the angle (Fig. 1A). In Gloucester, a retrotragal preauricular incision and a modified retro mandibular incision were used (Fig. 1B). Usually, the outer layer of the temporal fascia was divided above the zygomatic arch as described by Bramley and Al Kayat³⁷ to minimize the risk to the frontal branch of the facial nerve. In cases of complete bony ankylosis, the temporalis muscle was incised down to bone and raised with the skin flap, as described by Norman.38 Where there were previous scars, they were re-opened in preference to the above incisions, and any unsatis factory scars were excised.

The Vitek VK II system consists of a prosthetic fossa and condyle (Fig. 2A & B). The fossa is made from UPE with a Proplast II lining on its superior (non-articular) surface. It is trimmed to fit and then secured to the lateral aspect of the posterior zygomatic arch with titanium screws. The chrome cobalt-molybdenum alloy condylar prosthesis is fitted to the lateral aspect of the ramus after condylectomy. A metal template with a handle is used to position the condylar prosthesis correctly and allows the operator to mark the position of holes for the bolt and screws. The mandible should be placed in temporary inter maxillary fixation (IMF) at this stage. The condylar prosthesis should be sited carefully to ensure that is seated optimally in relation to the fossa. It is then secured with a titanium condyle bolt and two screws. There is a lining of Proplast II on its inner surface to encourage fibrous in growth for further anchorage. After Vitek filed for bankruptcy in 1990, we used remaining UK. and European stocks until production was resumed in Switzerland by Promotus in November 1995. The VK II was used in Birmingham from 1988 to 1996 and in Gloucester from 1989 to 1992. Production ceased in Switzerland in August 1996 and it is no longer available.

The Christensen system consists of a prosthetic fossa (Fig. 3A) and condyle (Fig. 3B), which are both made from chrome cobalt-molybdenum alloy. The correct fossa is selected from one of 33 preformed templates (Fig. 3C) and is then secured with identical alloy screws to the lateral aspect of the eminence. The condylar prosthesis is sized with acrylic templates, and secured with identical alloy screws. Until 1996, the condyle cap was made from polymethylmethacrylate (PMMA) and this design is still available. Recently, an all-metal condyle has become available and it is only this design that has been used in Birmingham. In Gloucester, it has been used since March 1997.

With both systems, time should be spent ensuring that the components are Fitted correctly. The condyle prosthesis in particular should not be compressed against the fossa at rest, nor should it press posteriorly against the tragus. It should sit in a neutral position with the teeth in occlusion.

Intermaxillary Fixation is released for the immediate postoperative period and can be continued later as elastic IMF if necessary. After about six weeks, mouth opening exercises are started in Birmingham, though in Gloucester they start on the second postoperative day and follow a three-month programme using the Therabite' appliance. Data were stored on a Microsoft Access database for analysis.

RESULTS

There were nine men (15%) and 53 women, and their age ranges at the time of operation were: 21-30 years (n=13); 31-40 years (n=9)\ 4-50 years (n=23): 51-60 years (n=ll); 6-70 years (n=4); and 71-80 years (n=2). The median age was 44.

A total of 86 joints were replaced. Twenty-seven Vitek VK II prostheses (31%) were placed in 17 patients (four men and 13 women), and 59 Christensen prostheses (69%) were placed in 45 patients (Five men and 40 women). Sixteen (Five Vitek VKL II and 11 Christensen) unilateral joints were placed on the left side; 22 (four Vitek VK: II and 18 Christensen) unilateral joints were placed on the right side: and 48 (18 Vitek VK II and 30 Christensen) joints were placed bilaterally.

Principal diagnoses are listed in Table 2.

Five of the 13 Birmingham patients had had a total of 23 previous operations, and 20 of the 49 Gloucester patients had undergone a total of 71 previous operations. The individual maximum was nine.

For imaging, we used orthopantomograms (OPT) (n=57): magnetic resonance imaging (MRI) (n=40); and computerized tomography (CT) (n=10). Some patients had more than one examination.

Twenty-eight patients were followed up for 1-12 months: 17 for 13-24 months; nine for 35-48 months; three for 49-60 months; two for 61-100 months; and three for 101-120 months (median 14.5).

Ability to eat was assessed by each patient's VAS on a scale of 1-10: scores 1-3 meant able to eat all food; scores 4-7 soft food only; and scores 8-10 liquid food only.

Preoperatively, 16 patients (26%) could eat only liquid food, 32 (51%) soft food; and 14 (23%) could eat all food. Postoperatively. 14 (23%) could eat soft food and 48 (77%n) could eat all food. None was left able to eat only liquid food (scores 8-10).

VAS scores 1-3 for pain were graded as low pain. 4-7 as moderate, and 8-10 as severe. Preoperatively, two patients (3%u) reported little pain; 21 (34%) moderate pain; and 39 (63%) had severe pain. Postoperatively this was reversed, with 38 (61%) reporting little pain, 21 (34%) moderate pain, and three (5%) severe pain.

Change in mouth opening postoperatively are shown in Figures 4-6. Some of the patients in whom it had got worse had recently been operated on (Birmingham n=5, and Gloucester n=7; Vitek VK II n=3, and Christensen n=9). There are similar patterns of change for the two sites and the two systems. There was no difference in functional outcome for those patients who had had previous operations on the TMJ and those who had not.

One patient's wound healing was delayed by un recognized vitamin C deficiency as a result of a poor diet. and an intolerance of the catgut sutures that had been used for subdermal wound closure. One patient developed a haematoma that required drainage, and one developed bilateral haematomas that drained temporary weakness of one or more branches of the spontaneously through the inferior incisions. Three facial nerve. patients had persisting paresis of the frontal branch of

None of the prostheses was rejected during the the facial nerve. About 10% of our patients had period of initial wound healing.

The three patients who continued to have severe pain after treatment and one other patient who continued to have moderate pain all had their Vitek VK II prostheses replaced by Christensen prostheses (three unilateral, and one bilateral). This relieved their symptoms. Samples of soft tissue from around the fossa prostheses of the Vitek VK II system showed histological evidence of foreign body giant cell reaction in all four patients. None of the Christensen prostheses required replacement. This gives an overall success rate of 58/62 (94%) in terms of patients treated and 81/86 (94%) in terms of joints replaced. For the Vitek VK II system this is 14/37 (82%) for patients treated and 24/27 (89%) for joints placed.

Forty-seven (76%) patients reported that they werevery satisfied with their treatment, 12 (19%) were moderately satisfied, and three (5%) were dissatisfied. These three were the patients who required replace ment of their Vitek VK II with Christensen prostheses.

The 1996 cost in the UK of a bilateral Vitek VK II case was �3200, after which time that system became unavailable. The 1998 cost of the Christensen system is �6300 for bilateral prostheses.

DISCUSSION

We placed 86 total prosthetic TMJs in 62 patients. Women outnumbered men by 5.7:1, and two-thirds of the patients were over 40 years old. Almost three- quarters of the patients were treated for arthritic involvement of the TMJ by osteoarthritis, rheumatoid arthritis, or psoriasis. The remainder had other conditions of which the most common was ankylosis, although ankylosis was also a presenting feature in some of those with arthritic disease. This group therefore differed from those with TMJ dysfunction (stages I, II, or III in the classification of the American Society of Temporomandibular Surgeons¹) in terms of age distribution and severity of disease. This also distinguished them from those with atypical facial pain, in whom there is usually no obvious disease. However, more than half the patients had under gone previous operations on the TMJ, the maximum individual total being nine. In some patients, those procedures were undertaken for earlier stages of disease; this initiated a sequence that culminated in total joint replacement.

We each used slightly different surgical approaches to the ramus of the mandible. In Birmingham, where the Vitek VK II system was used until recently, the approach followed the recommendations that accompanied that system. That ramus incision lies between the buccal and mandibular branches of the facial nerve. It provides a direct approach but risks leaving a more noticeable scar. The longer retromandibular incision that was used in Gloucester is probably better cosmetically, particularly in younger patients.^39,40

We have noticed that our radiologists are becoming increasingly confident about commenting on osseous detail from MRI scans of the TMJ. As with CT, it is now possible to obtain both sagittal and coronal MRI images.⁴¹

Our duration of follow-up ranged from one month to 10 years, with a median of 14.5 months. Only five patients had been followed up for five years or more. The follow-up data in Table 1 confirm that long-term data are not available for this type of surgery. It will be important to continue to monitor groups of patients such as ours over the coming years, particularly the younger patients. At present, it is not even possible to say whether a prosthetic TMJ is likely to last longer than, say, a hip prosthesis.

McBride³³ considered that reports of results should include enough procedures done for similar problems, sufficient objective data, and a minimum of one year (and preferably three-year) follow-up for every joint to permit meaningful comparison with other reports. Postoperative vertical, protrusive, and lateral range of movement of the mandible; analogue symptom scales prepared by patients; details of the occlusion; complications and their long-term consequences; incidence and types of reoperation; and degree of overall patient satisfaction, should be presented. Our data adhere to these recommendations with the exception of protrusive and lateral range of motion of the mandible. However, we did assess ability to eat different types of food, and found that none was left able to eat only liquid food postoperatively. The number who could eat all food increased from 14 (23%) of the total group preoperatively to 48 (77%) postoperatively. Preoperatively, 39 (63%) reported severe pain but this number reduced to three (5%) postoperatively. These improvements are consistent with those reported by McBride³¹ for the Vitek VK II system and Chase³⁴ for the Christensen system.

We found a maximum improvement in mouth opening of 2.6 cm with the Vitek VK II system and 3.0 cm with the Christensen system. The most extreme changes for the worse were 0.4 cm and 2.3 cm, respectively. The greater change for the worse in some patients with the Christensen system is partly explained by its more recent insertion in both centres.

We initially suspected that those who had three or more previous operations on the TMJ would have a worse outcome in terms of pain, dietary upset, and jaw mobility. However, this was not confirmed by our data.

One of the most important considerations for any type of implant is failure. While we did not encounter any immediate rejection problems, both centres have had longer-term problems with the Vitek VK II system. Four of our patients required replacement of five VK II joints by Christensen prostheses. There was evidence of foreign body giant cell reaction in all those cases. Our overall percentage success rate is therefore 94% in terms of patients treated and 94% in terms of joints re-placed. This is reflected in the patient satisfaction scores; 95% were either very satisfied (76%) or moderately satisfied (19%) with their treatment.

The main problems associated with total TMJ reconstruction relate to wear at the articular surfaces, foreign body reaction, mobility of the implant with displacement, and implant fracture³³ caused by the use of inappropriate alloplastic materials. Fontenot³⁶ described the problems associated with Teflon Fluorocarbon polymers such as Teflon PTFE and Teflon FEP. Proplast was introduced in the 1970s as a porous composite material that was designed to stabilize devices by allowing the in growth of tissue into its porous structure. It initially consisted of Teflon PTFE and vitreous carbon, but this was subsequently changed to Proplast II (Teflon PTFE-aluminium oxide) and then Proplast IIA (Teflon PTFE-hydroxy apatite). The VK II fossa used Proplast II, Nomex � (a polyamide fabric, Dupont), and UPE. In laboratory testing in which devices were tested until failure, both the VK I and VK II fossas wore through the Teflon FEP or UPE surface into the Nomex fabric; however, this wear was much greater in the Teflon FEP than the UPE material. A TMJ simulator produced a wear rate of 1.18 mm per 100 000 cycles for Teflon FEP compared with 0.01 for UPE. Despite a lower wear rate, such testing confirms that it is still possible for UPE to wear, degenerate, and produce particulate matter. Wolford et a1.⁴² found that the foreign body giant cell reaction to Proplast-Teflon implants is proliferative, and worsens with time as more particles are generated. Cartilage and bone degenerate and resorb. They also found abnormalities in lymphocyte subset ratios, which then improved towards normal when the Proplast-Teflon implants were removed and replaced with the Techmedica custom-made total joint prostheses. It is still not clear whether the foreign body reactions seen are caused by the paniculate matter from wear of the artificial artic ular surface or the Proplast II (which can sometimes be associated with extensive adjacent bony destruction or both these reasons. These problems do not seem to affect the Christensen system^3,33 and our own experience supports this.

We found fewer problems with the Christensen system than with the Vitek VK II system (which is no longer available). A randomized trial would offer much stronger evidence in support of choice of treatment, but would be impossible to conduct at present in the UK as only the Christensen system is available. It will be important to report long-term follow-up data in the future.

References

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The Authors

Consultant Oral and Maxillofacial Surgeon

D. Powell MIMPT, MIHSM

Chief Maxillofacial Technologist
City Hospital NHS Trust
Dudley Road Birmingham
Tel: 0 121 554 3801 Fax: 0 121 5074315

R. Hensher FRCS, FDSRCS

Consultant Oral and Maxillofacial Surgeon
Gloucestershire Royal Hospital
Gloucester, UK

Correspondence and requests for offprints to: Mr B. Speculand, Consultant Oral and Maxillofacial Surgeon, City Hospital NHS Trust, Dudley Road, Birmingham BIS 7QH, UK. Tel: +44 (0)121 554 3801; Fax: +44 (0)121 507 4315

Paper received 6 February 1999
Accepted I March 2000

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