Recommendations for management of patients with temporomandibular joint implants

J Oral Maxillofac Surg 51:1164-1172,1993

Recommendations for Management of Patients With Temporomandibular Joint Implants ticipants were recognized oral and maxillofacial surgery experts and two were clinicians experienced in nonsurgical management of temporomandibular disorders. In addition, six experts in various aspects of biomaterials, joint reconstruction, TMJ radiology, and metaanalysis were invited to present papers at the opening plenary session and to attend the workshop sessions. Also present was an observer from the National Institute for Dental Research. Following is a list of workshop participants:

History of AAOMS Involvement In December 1990 the FDA issued an "alert" urging oral and maxillofacial surgeons to reexamine all of their patients who had received Vitek, Inc or Oral Surgery Marketing, Inc temporomandibular joint (TMJ) interpositional implants. This notification was issued in response to reports of these implants undergoing fragmentation and perforation, and causing a foreign body response resulting in progressive bony degeneration of the condyle and glenoid fossa. AAOMS responded by providing membership mailing labels to the Food and Drug Administration (FDA) and subsequently calling attention to the notice in the AAOMS media. In September 1991 the FDA issued a public health advisory regarding the suggested management of patients with interpositional implants as well as those with Vitek glenoid fossa and condylar implants. This notice was reprinted in the AAOMS Digest in October 1991. In June 1992 the House of Representatives' Government Operations, Human Resources and Intergovernmental Relations Subcommittee held a hearing in which they questioned whether the FDA and National Institutes of Health (NIH) had acted appropriately to protect the public with respect to TMJ implants. Testimony at this hearing included presentations by AAOMS Fellows Drs Daniel M. Laskin and Larry M. Wolford. This congressional hearing was subsequently discussed at the meeting of the Board of Trustees in June 1992 and a Special Committee on TMJ Implants was established to develop means for AAOMS to respond proactively to the TMJ implant problem. This committee met in June 1992 and discussed what actions the Association should take. These included immediate issuance of a TMJ Implant Advisory; meeting with the FDA; and development of a workshop to discuss recommendations for treatment options and questions for research. Subsequent to this meeting, AAOMS representatives met with officials and staff of the FDA in July 1992 to discuss questions regarding patient abandonment, device approval, and notification of oral and maxillofacial surgeons regarding management of TMJ implant patients. AAOMS indicated that it would be sending out a TMJ Implant Advisory to the fellowship, would be willing to cooperate in an FDA survey, and agreed to submit indications for compassionate use of total TMJ implants. The advisory was distributed in August 1992 and reprinted in the October 1992 issue of JOMS.

The Organizing Committee

Dr Daniel M. Laskin-Chairman Richmond, VA Dr Kenneth S. Rotskoff St Louis, MO Dr Doran E. Ryan Milwaukee, WI Dr James F Kelly Rosemont, IL (Ex officio: Director, Research, AAOMS)

PARTICIPANTS IN THE DELIBERATIONS

Dr Leon A. Assael Dr Thomas Braun Dr Sidney L. Bronstein Dr John J. Delfino Dr Leslie B. Heffez Dr John F. Helfrick Dr A. Thomas Indresano Dr John N. Kent Dr Michael G. Koslin Dr Robert B. MacIntosh Dr Louis G. Mercuri Dr Ralph G. Merrill Dr Michael Montgomery Dr Peter Quinn Dr Kenneth S. Rotskoff Dr Doran E. Ryan Dr Robert D. Schwartz Dr Myron R. Tucker Dr Bruce Sanders Dr Eric Schiffman Dr Robert V. Walker Dr Larry M. Wolford

A Workshop on Temporomandibular Joint Implant Surgery In November 1992 AAOMS convened a 2 1/Hlay workshop attended by 23 invited participants. Twenty-one of the par-

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Farmington, CT Pittsburgh, PA Denver, CO St Louis, MO Chicago,IL Houston, TX Milwaukee, WI New Orleans, LA Birmingham, AL Bingham Farms, MI Maywood,IL Portland, OR San Antonio, TX Philadelphia, PA St Louis, MO Milwaukee, WI Chicago,IL Charlotte, NC Santa Monica, CA Minneapolis, MN Dallas, TX Dallas, TX

RECOMMENDATIONS FOR MANAGEMENT OF TMJ IMPLANTS

SPEAKERS AT THE OPENING PLENARY SESSION AND THE TITLE OFTHEIR PRESENTATION

Problems in the Design and Conduct ofClinical Trials Dr Raymond A. Dionne Clinical Pharmacology Unit National Institute for Dental Research Bethesda, MD

An Overview ofthe Use of Biomaterials in Joint

Reconstruction Dr Timothy Wright Hospital for Special Surgery New York, NY

Immunopathologic Response ofJoint Tissue to Alloplastic Implant Materials Dr William Jiranek Massachusetts General Hospital Boston, MA

An Overview ojthe Orthopedic Surgery Experience With Alloplastic Implants for Joint Reconstruction Dr Gary Friedlaender Yale University New Haven, CT

Diagnostic Imaging of the Temporomandibular Joint Reconstructed With Alloplastic Implants Dr Per-Lennart Westesson University of Rochester Rochester, NY

M etaanalysis ofStudies Evaluating Temporomandibular Joint Implant Surgery Dr Alexia Antczak-Bouckorns Harvard University Boston, MA OBSERVER

Dr Patricia Bryant National Institute for Dental Research

Charge to the Workshop The following charges were issued to the workshop participants: Develop a consensus concerning the lise ofinterpositional and reconstructive materials (ic, Teflon-Proplast, Silastic, total joints. autogenous tissues and nonreplacement) in the temporomandibular joint.

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Develop a consensus concerning the management ofpatients in whom temporomandibular joint implants hare been placed (ie, Teflon-Proplast, Silastic, total joint) and 1\-/10 are either symptomatic or asymptomatic at the time of presentation. Take into account the Indications for Care. Therapeutic Goals. Factors Affecting Risk, Standards ofCare. Known Risks and Complications and Favorable Outcomes as presented in the Parameters of Care for Oral and Maxillofacial Surgery. In preparation for the workshop deliberations, participants were sent a large collection of previously published articles from the oral and maxillofacial surgery, orthopedic surgery, and biomaterials literature (Appendix A). They were requested to familiarize themselves with the material and to rate each article for scientific value. A Literature Analysis scoring sheet for each of the articles was provided to the workshop participants. They were asked to score the papers as adequate (I), fair (2), or inadequate (3) against 10 criteria and also to establish an overall rating using the same rating scale. The participants were provided a document that contained definitions of each of the IO criteria (Appendix B). The following instructions were sent to the workshop participants: The articles .1'011 hare received are for your analysis in anticipation ofthe TMJ Implant Surgery Workshop. We are asking )'011 to complete such an analysis so that I\'ecan employ the data as background to our workshop deliberations. Enclosed is a Literature Analysis scoring sheet for each article that )'011 hare received. We hare established lO criteria against which Ire would like )'011 to analyze each of the articles. There is also a place for GIl Overall Rating as well as a space for any comments )'011 wish to make. Accompanying the Literature Analysis scoring sheet is GIl additional document containing definitions to assist in your interpretation ofeach criterion. The articles hare been divided into topical categories and printed on color coded paper to assist yOllin organizing them for your analyses. We hare printed the Literature Analysis sheets on the same color paper as the corresponding article to help )'011 with your organization ofthe material. Categories Postsurgical Status (cg, tissue reaction. complications, degeneration) Biology ofJoints Reconstruction of Temporomandibular Joint (es. follow-up, evaluation, assessment) Biomaterials, Materials Biocompatibiltty Animal Studies Orthopedic Joint Reconstruction

The final charge to the workshop was to develop a prioritized list of clinical and laboratory research questions that needed to be addressed regarding the surgical management ofTMJ disorders and to establish a consensus regarding the research strategies that should be used to address these clinical issues, including prospective clinical trials, retrospective clinical trials, registries and outcome studies. Their recommendations in this regard will be presented in a separate report. A draft of the workshop recommendations was presented to attendees at a meeting ofthe AAOMS Temporomandibular Joint Clinical Interest Group on February 2, 1993, as a means of obtaining reaction from AAOMS members.

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RECOMMENDATIONS FOR MANAGEMENT OF TMJ IMPLANTS

The following is a summary of the workshop deliberations on the use of interpositional and reconstructive materials, and on the management of patients with alloplastic TMJ implants. The recommendations presented represent a consensus of the workshop participants and arc not an official statement of the AAOMS. It is evident that final treatment decisions should be based on the views of the patient and the clinician. Such decisions should be made in light of reported scientific, clinical, regulatory, and manufacturer's information concerning the clinical condition, procedure, or device under consideration. There may be good clinical reasons to deviate from existing patient management recommendations (e.g., parameters of care, consensus reports, guidelines). When a surgeon chooses to deviate from existing recommendations, based on the circumstances of an individual patient, it is advisable to docutnent in the patient's record the reasons for the procedure followed. Additionally, in those instances where the patient has been advised of the risks associated with retaining an implant and refuses treatment, it is advisable to document the informed refusal of the patient.

Use of Interpositional and Reconstructive Materials TEFLON-PROPLAST

It was the. consensus of the workshop participants that the use ofTeflon-Prop last interpositional implants should be discontinued because it is an inappropriate material for this purpose. TOTAL JOINT REPLACEMENT

Alloplastic total joint replacement is an option in patients with extensive TMJ disease. However, because the long-term outcomes with currently available total joints have yet to be determined, such devices should be considered only when their safety and efficacy have been established by a recognized regulatory agency. SILASTIC

It was the consensus ofthe workshop that permanent placement of Silastic as an interpositional material in the TMJ should no longer be done except when used to prevent recurrence ofankylosis. There was a diversity of opinion concerning the use of temporary Silastic following discectomy.* AUTOGENOUS MATERIALS

A costochondral graft is the currently preferred material for condylar replacement when autogenous tissue

* Since the workshop, SILASTIC~ H.P. Sheeting and SILASTIC~ TMJ Implant (Wilkes Design)have been discontinued (Dow Coming Wright letter, January 25, 1993).

is used. Autogenous tissue is also appropriate for disc and fossa repair and replacement, for use as an interpositional material to prevent reankylosis, and for augmentation of the articular eminence. NONREPLACEMENT OF THE DISC

It was the consensus, based on the available literature, that discectomy without replacement, accompanied by physical therapy, is an acceptable procedure when there are minimal or no bony changes. However, in patients with more extensive bony changes, disc replacement may be necessary.

Management of Patients With Alloplastic TMJ Implants The following are recommendations for the management of patients who have received a Teflon-Proplast interpositional implant or a total joint prosthesis with a Teflon-Proplast fossa. Data concerning the absolute number ofsuch implants placed and the absolute or relative number of such implants removed are not available. The literature supports that in patients who require implant removal there is evidence of tissue destruction and a foreign body reaction adjacent to the implant. Patients are organized into four categories depending on their clinical and imaging status at the time of presentation (see categories below). TEFLON-PROPLAST INTERPOSITIONAL IMPLANT

Category I (Asymptomatic With No Change on Imaging) 1. Advise patient of the risks of retaining/removing

the implant. Recommend removal of implant and affected soft tissues. Ifpatient refuses removal of implant, advise of the necessity for periodic monitoring. Follow-up with magnetic resonance imaging (MRI) and/or computed tomography (CT) at least yearly for 5 years after the time the implant was placed, then discontinue imaging if asymptomatic. Advise patient of need for continuing periodic follow-up examinations. If at any time symptoms and/or imaging changes develop, manage the patient consistent with recommendations for Categories II, III and IV. 2. If replacement is done, use of autogenous tissue is suggested. A minority ofworkshop participants did not believe implants containing Teflon-Proplast need to be removed in patients who are asymptomatic with no imaging changes. They believe these patients should be

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RECOMMENDATIONS FOR MANAGEMENT OF TMJ IMPLANTS

followed at least yearly for changes in clinical or imaging status. If changes occur in such patients, they should be managed consistent with recommendations for Category II, Ill, and IV patients.

Category II (Asymptomatic With Imaging Changes); Category III (Symptomatic Wit/101It Imaging Changes); Category IV (Symptomatic With Imaging Changes) 1. Recommend removal ofimplant and affected soft tissues. Follow-up postoperatively with MRI and/ or CT at least yearly for 5 years, then discontinue imaging if asymptomatic and any previous changes are stable. Reoperate and do further debridement if symptoms develop or recur. Advise patient of need for periodic follow-up examinations. 2. If no imaging changes are present, replacement after implant removal may not be necessary. If bony changes are present , reconstruction, if required, may be immediate or delayed using autogenous tissues or a total joint prosthesis for which safety and efficacy have been established by a recognized regulatory agency. 3. If patient refuses implant removal, follow-up at least yearly with clinical examination and MRI and/or CT. 4. If there is a large perforation into the middle cranial fossa, repair with temporalis muscle or a bone graft should be considered. TOTAL JOINT PROSTHESIS

Category I (Asymptomatic With No Change on Imaging) I. Evaluate yearly by clinical examination and radiographic imaging for at least 2 years. If condition remains stable, advise patient of need for periodic follow-up examinations.

Category II (Asymptomatic With Imaging Changes) I. Do baseline tomographic imaging and repeat at 6 months to see if condition is stable. If no further change, follow-up at yearly intervals for at least 2 years. Ifcondition remains stable, advise patient of need for periodic follow-up examinations. 2. If changes are progressive, remove total joint, debride the area , and replace with a costochondral graft or a total joint prosthesis for which safety and efficacyhave been established by a recognized regulatory agency. Evaluate yearly by clinical examination and radiographic imaging for at least

2 years. If condition remains stable, ad visepatient of need for periodic follow-up examinations.

Category III (Symptomatic Without Imaging Changes) I. Evaluate by history and physical examination to rule out other causes of symptoms. 2. If condition appears to be due to a foreign body reaction, remove total joint, debride the area, and replace with costochondral graft or total joint prosthesis for which safety and efficacyhave been established by a recognized regulatory agency. Evaluate yearly by clinical examination and radiographic imaging for at least 2 years. If condition remains stable, advise patient of need for periodic follow-up examinations.

Category IV (Symptomatic With Imaging Changes) I. Remove total joint, debride the area, and replace with costochondral graft or total joint prosthesis for which safety and efficacy have been established by a recognized regulatory agency. Evaluate yearly by clinical examination and radiographic imaging for at least 2 years. If condition remains stable, advise patient of need for periodic followup examinations. SILASTIC

The following recommendations are made for the management of patients who have received a Silastic implant and return to the original surgeon or another practitioner for care.

Category I (Asymptomatic With No Change on Imaging) I. Advise patient of the risks and benefits of retaining/removing the implant. 2. If patient chooses to retain implant, follow-up with CT or tomography yearly for at least 2 years. 3. Ifcondition remains stable, advise patient of need for periodic follow-up examinations.

Category II (Asymptomatic With Imaging Changes) I. Advise patient of the risks and benefits of retaining/removing the implant. 2. If patient chooses to retain implant, obtain CT or tomography at 6 months to determine if imaging changes are progressive. If changes are progressive, remove implant. If previously observed imaging changes are stable, repeat CT or tomography yearly for at least 2 years.

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RECOMMENDATIONS FOR MANAGEMENT OF TMJ IMPLANTS

3. If condition continues to remains stable, advise patient of need for periodic follow-up examinations.

Category III (Symptomatic Without Imaging Changes) l. Advise patient of the risks and benefits of retaining/removing the implant. 2. Ifpatient chooses to retain implant, provide supportive care and follow-up with CT or tomography at 6 months. If symptoms persist at 6 months, remove implant. If patient becomes asymptomatic and chooses to retain implant, repeat CT or tomography at 6 months and then yearly for at least 2 years. 3. Ifcondition remains stable, advise patient of need for periodic follow-up examinations.

tain implant, provide supportive care and followup with CT or tomography at 6 months. If at 6 months, imaging changes are progressive and/or symptoms persist, advise removal ofthe implant. Ifpatient becomes asymptomatic and chooses to retain implant, repeat CT or tomography at 6 months and then yearly for at least 2 years. If condition has remained stable, advise patient of need for periodic follow-up examinations.

Replacement of a Silastic implant. If a patient elects to have an implant removed, either do not replace the implant or replace it with autogenous tissue. lfbony changes are severe enough to warrant joint reconstruction, replacement with either autogenous tissue or a total joint prosthesis for which safety and efficacy have been established by a recognized regulatory agency is appropriate.

Category IV (Symptomatic With Imaging Changes) 1. Advise patient of the risks and benefits of retaining/removing the implant. 2. If imaging changes are slight, provide supportive care and follow-up with CT or tomography at 6 months. If imaging changes are progressive, advise removal of the implant. If imaging changes remain stable, repeat imaging at 6 months and then yearly for at least 2 years. If condition continues to remain stable, advise patient of need for periodic follow-up examinations. 3. If imaging changes are moderate to severe, advise removal of the implant. Ifpatient chooses to re-

COMMENTS

The procedures followed in reviewing the literature in preparation for this workshop had a definite, although not measurable, influence on the recommendations. The participants expressed the opinion that their input to the deliberations was significantly affected by the manner in which they were asked to analyze the literature. Although they were familiar with the literature, having previously read most of the papers and reports provided, their conclusions were influenced by the application of these objective criteria.

Appendix A Literature Reviewed for Temporomandibular Joint Implant Surgery Workshop November 20-22, 1992

Acton, c., Hoffman, G., et aI. Silicone-induced foreign body reaction after temporomandibular joint arthroplasty. Case report, Aust. Dent. J.; 34: 228, 1989. Aptekar, R.G., Davie, J.M. and Cattell, H.S. Foreign body reaction to silicone. Clin. Orthopaedics Related Rsch.; 98: 231-2, 1974. Bassleer, R., et al. Histologic structure and functions of synovium. International Symposium on Articular Synovium. Bruges, 198/. Berarducci, J., Thompson, D. and Scheffer, R. Perforation into middle cranial fossa as a sequel to use of Proplast-Teflon implant for temporomandibular reconstruction. J. Oral Maxillofac. Surg.; 48: 496, 1990. Berman, D.N. and Bronstein, S. Osteophytic reaction to a polytetrafluoroethylene temporomandibular joint implant. O. Surg. O. Med. O. Path.; 69: 20-3, 1990. Bosanquet, A.G., Ishimaru, J. and Goss, A.N. The effect ofSilastic replacement following discectomy in sheep temporomandibular joints. J. Oral Maxillofac. Surg.; 49 (I I): 1204-9, 1991. Braun, T. and Kent, J. Temporomandibular joint surgery. Part II: Partial and total joint reconstruction, osseous procedures, and joint rehabilitation. Selected Readings in Oral and Maxillofac. Surg.; Vol. 1, No.4. Bronstein, S. Retained alloplastic temporomandibular joint disk implants: A retrospective study. O. Surg. O. Mcd. O. Path.; 64: 135-45, 1987.

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Brown, W.A. Internal deran gement of the temporomandibular joint: review of214 patients following meniscectomy. Canad. J . Surg.; 23: 30. 1980. Buchhorn , G.H. and Willert, H.G. Effectsof plastic wear particles on tissue. In Williams, D.E, ed, Biocompatibility ofOrthopedic Implants. Vol. II Boca Raton, FL: CRC Press. 1982. Charnley, J. Tissue reactions to polytetrafluoroethylene, Lancet.; 2: 1379, 1963. Christensen , W.R. Arthroplastic implantation of the TMJ. In Thomas, c.e., ed, Oral Ltnplantology; Springfield: 284-98, 1970 . Daniels, S., Ellis, E. and Carlson, D.S. Histologic analysis of costochondral and sternoclavicular grafts in the TMJ ofthe juvenile monkey. J. Oral Maxillofac. Surg.; 45: 675, 1987. Dolwick, M.F. and Aufdemorte, T.B. Silicone-induced foreign body reaction and lymphadenopathy after temporomandibular joint arthroplasty. Oral Surg.: 59: 449, 1978. Dolwick, E, Reid, R., et al. Criteria for TMJ Meniscus Surgery. Ad Hoe Study Group 011 TMJ Meniscus Surgery. Rosemont, IL: AAOM S , 1984. Ellis, E. and Carlson , D.S. Histologic comparison of the costochondral, sternoclavicular, and temporomandibular joints during growth in Macaca mulata . J. Oral Maxillofac. Surg.; 44: 312. 1986. Eriksson, L. and Westesson, P.-L. Deterioration of temporary silicone implant in the temporomandibular joint: A clinical and arthroscopic follow-up study. J . Oral Maxillofac. Surg.; 62 (1): 2-6. 1986. Eriksson, L. and Westesson, P.-L. Long-term evaluation of meniscectomy of the temporomand ibular joint. J. Oral Maxillofac. Surg.; 43: 263. 1985. Eriksson, L. and Westesson, P.-L. Temporomandibular joint diskectomy: No positive effect of temporary silicone implant in a 5-year follow-up. O. Surg. O. Med. O. Parh.; 74 (3): 259-72. Sept. 1992. Estabrook s, L.N., et al. The role of cond ylotomy with interpositional silicone rubber in 1'MJ ankylosis. Oral Surg.; 34: 2-6, /972. Estabrooks, L.N., Fairbanks, C; et al. A retrospective evaluation of 301 1'MJ Proplast-Tcflon implants. Oral Surg.; 70: 381, 1990. Fallon, M.D., Teitelbaum, S. and Kahn, A. Multinucleation enhances macrophage-mediated bone resorption. US-Callad. Dlv. of 11lI '1. Academy of Patlt.: 49: 2: 159-64, 1983. Feinberg, S.E. and Larsen, P. The use of a pedicled temporalis muscle-pericranial flap for replacement of the TMJ disc: A preliminary report. J. Oral Maxillofac. Surg.; 47: 142, 1989. Florine, B.L., Gattov D.L, et al. Tomographic evaluation of temporomandibular joints following discoplasty or placement of polytetrafluoroethylene implants. J. Oral Maxillofac. Surg.; 48: 183-8, 1988. Fontenot, M.G. and Kent, J.R. In vitro wear performance of Proplast TMJ disc implants. J, Oral Maxillofac. Surg.: 50: 133, 1992, Georgiade, N.G . The surgical .correction of temporomandibular joint dysfunction by means of autogenous dermal grafts.Plnst. Rcconst. Surg.: 30: 68, 1962. Gibeault, D., Wang, W., et al. Use of cross-linked bovine pericardium as a disc replacem ent in the rabbit TMJ. J. Oral Maxillcfac. Surg.; 47: 828, 1989. Gordon, M. and Bullough, P.G. Synovial and osseous inflammation in failed silicone-rubber prostheses. J . of Balle and Joint Surg.; 64: 574-80. 1982. Gundlach, K.K. Long-term results following surgical treatment of internal derangement of the temporomandibular joint. J. Crani omax. Surg.; 18 (5): 206-9, 1990. Hall, H.D. Meniscectomy for damaged disks of the temporomandibular joint. South. M ed.; 78: 569, 1985. Hall, M.B., Baughman, R., et al. Healing following meniscoplasty, eminectorny, and high condylectomy in the monkey temporomandibular joint. J. Oral Maxillofac. Surg.; 44: 177, 1986. Hambley, W. and Horn, K.L. Failure of Proplast in mastoid obliteration. ~JIIl. J. 0101.; 2: 286-8. /98/. Harris, W. and Sledge, C. Total hip and total knee replacement: Part I. N. Engl. J . Mcd.; 323 (11): 725-80. 1990. Harris, W. and Sledge, C. Total hip and total knee replacement: Part II. N. Engl. J . Med.: 323 (12): 801-8, 1990. Heffez, L., et al. CT evaluation ofTMJ disk replacement with a Proplast-Teflon laminate. J. Oral Maxillofac. Surg.; 45: 65765.1987. Herbosa, E.G. and Rotskoff, K.S. Composite temporalis pedicle flap as an interpositional graft in temporomandibular joint arthroplasty: A preliminary report . J. Oral Maxillofac. Surg.: 48: 1049-56, 1990. Hinton. RJ. Alterations in rat condylar cartilage following discectomy. J. Dent . Res.; 71 (6): 1292-7. Jun e 1992. Hohl, T.H. and Tucek, \V.H. Measurement of condylar loading forces by instrumented prosthesis. J. Maxillofac. Surg.; 10: 17, 1982. Holmlund, A. and Axelsson, S. Diskectomy in treatment of disk derangement. A one and three year follow-up. Sired. Delli. J.; 14 (5): 213-8, 1990 . Hornsy, C.A. Biocompatibility of perfluorinatcd polymers and composites of these polymers. In Williams, D.E, cd. Biocompatib ility of Clinical Implant Materials. Vol. II. Boca Raton, FL: CRC Press, 1981, pp 59-77. House, L.R., Morgan, H., et al, Temporomandibular joint surgery: Results of a 14-year joint implant study. Laryngoscope; 94: 4, 1984. Hunsuck, E. Autogenous grafts for replacing temporomandibular joints and mandibular condyles in rhesus monkeys . J . Oral Surg.: 27: 167, 1969. Hylander, \V. The human mandible: Lever or link? Am. J. Pltys. Anthrop.: 43: 227, 1975. Ioannides, C. and Freihofcr, H. Replacement of the dam aged articular disk of the TMJ . J. Cranio-Max. Fac. Surg.; 16: 273. 1988. loannides, e. and Maltha, J. Lyophilized auricular cartilage as a replacement for the interarticular disc of the craniomandibular joint: An experimental study in guinea pigs. J. Cranio-Max-Fac. Surg. ; 16: 295-300. 1988.

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James, D.R. and Irvine, G. Autogenous rib grafts in maxillofacial surgery. J. Oral Maxillofac. Surg.; 11: 201-3, 1983. James, R.B. Surgical treatment oftemporomandibular joint dysfunction. In English, Gerald, M., ed. Otolaryngology. Philadelphia: J.B. Lippencott, 1988. Jasty, M., and Smith, E. Wear particles of total joint replacements and their role in periprosthetic osteolysis. Current Opinion in Rheumatology; 4: 204-9, 1992. Kalamichi, S., and Walker, R.V. Silastic implants as part of temporomandibular joint arthroplasty. Evaluation of its efficacy. Br. J. Oral Maxillofac. Surg.; 25: 227, 1987. Kaplan, P.A., et al. Erosive arthritis of the temporomandibular joint caused by Teflon-Proplast implants: Plain film features. AJR; 151: 337-9, 1988. Katzberg, R.W. and Laskin, D. Radiographic and clinical significance of temporomandibular joint alloplastic disk implants. AJR: 151: 736-7,1988. Kent, J.N., Block, M.S., et al. Experience with a polymer glenoid fossa prosthesis for partial or total temporomandibular joint reconstruction. J. Oral Maxillofac. Surg.; 44: 520-33, July 1986. Kent, J.N., Block, M.S., et al. Five-year follow-up on polymer glenoid fossa prosthesis for partial and total TMJ reconstruction. J. Oral Maxillofac. Surg.; 46: M 15, 1988. Kent, J.N., Block, M., Halpern, J. and Fontenot, M. Update on VK and total TMJ system. Manuscript. OS39/8, June 22, 1992. Kent, J.N., Misiek, DJ., Akin, R.K., Hinds, E.C. and Homsy, CA. Temporomandibular joint condylar prosthesis: A ten-year report. J. Oral Maxillofac. Surg.; 41: 245-54, 1983. Kneeland, J.B., et al. MR imaging ofa fractured temporomandibular disk prosthesis. J. Comput. Assist. Tomogr.; Vol. 11: 199200,1987. Kneeland, J.B., Ryan, D., et al. Failed temporomandibular joint prostheses: MR imaging. Radiology; 165: 179, 1987. Lagrotteria, L., et al. Patient with lymphadenopathy following temporomandibular joint arthroplasty with Proplast. J. Craniotnandib. Prac.; 4: 172-8, 1986. Lindqvist, C, Jokinen, J., et al. Adaptation of autogenous costochondral grafts used for temporomandibular joint reconstruction: A long-term clinical and radiologic follow-up. J. Oral Maxillofac. Surg.; 46: 465-70, 1988. Lindqvist, C, Soderholm, A., et al. Erosion and heterotopic bone formation after alloplastic temporomandibular joint reconstruction. J. Oral Maxillofac. Surg.; 50: 942-9, 1992. Livermore, J., et al. Effect of femoral head size on wear of the polyethylene acetabular component. J. Bone Joint Surg.; 72A(4): 518, 1990. Macher, D., Westesson, P.-L., et aI. Temporomandibular joint: Surgically created dise displacement causes arthrosis in the rabbit. O. Surg. O. Med. O. Path.; 73: 645-9, 1992. Markowitz, N.R., Catone, G.A., Merrill, R., Wolford, D.G. and Hawkinson, R. Immediate permanent reconstruction of a mandibular defect with use of a prosthesis of chromium-cobalt alloy. JADA; 98: 943-6. 1979. Matukas, V. and Lachner, J. The use of autogenous auricular cartilage for temporomandibular joint discectomy replacement: A preliminary report. J. Oral Maxillofac. Surg.; 48:348, 1988. McKellop, H. and Sarmiento, A. In vivo wear of titanium-alloy hip prostheses. J. Bone Joint Surg.; 72-A(4), 1990. Meyer, R.A. The autogenous dermal graft in temporomandibular joint disc surgery. J. Oral Maxillofac. Surg.; 46: 948, 1988. Moorthy, A.P. and Finch, L.D. Interpositional arthroplasty for ankylosis of the temporomandibular joint. O. Surg. O. Mcd. O. Path.; 55: 545-52, 1983. Morgan, D.H. Development of alloplastic materials for temporomandibular joint prostheses: A historical perspective with clinical illustrations. Oral Surg.; 10 (3): 192-204, 1992. Moriconi, E.S., Popowich, L.D. and Guernsey, L.H. Alloplastic reconstruction of the temporomandibular joint. Dent. Clin. N. Am.; 30: 307-25, 1986. Nalbandian, R.M., Swanson, A.B. and Maupin, B.K. Long-term silicone implant arthroplasty. Implications of animal and human findings. JAMA; 250: 1195-8, 1983. Obeid, G., Guttenberg, S.A. and Connole, P. Costochondral grafting in condylar replacement and mandibular reconstruction. J. Oral Maxillofac. Surg.; 46: 177, 1988. Pazzaglia, U.E. and Pringle, J. Bone resorption in vitro: Macrophages and giant cells from failed total hip replacement vs. osteoclasts. Biomatcrials: 10: 286-8, MOl' 1989. Pazzaglia, U.E. and Pringle, J. The role of macrophages and giant cells in loosening ofjoint replacement. Arch. Orthop. Trauma Surg.; 107: 20-6, 1988. Pogrel, M.A. and Kaban, L.B. The role of a temporalis fasia and muscle flap in temporomandibular joint surgery. J. Oral Maxillofac. Surg.; 48: 14-9, 1990. Politis, C, Fossoin, E. and Bossuyt, M. The usc of costochondral grafts in arthroplasty of the temporomandibular joint. J. Cranio-Max-Fac. Surg.; 15: 345, 1987. Politis, C, Stoelinga, PJ.W., et aI. Long-term results ofsurgical intervention on the temporomandibular joint. J. Craniomandib. 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Appendix B Criteria for Literature Analysis Tempormandibular Joint Implant Surgery Workshop November 20-22, 1992

The following definitions are intended to assist the reviewer in rating papers against the stated criteria. The elements included in the definitions are those which a paper rated adequate (I) should contain. Statement oj Objectivcls): A clear description of the objectives of the study and/or the paper. The description should be presented in objective rather than testimonial terms and should discuss therapeutic goals and outcome measures. Description of Study Design: A precise description of the materials and methods of the study . If the paper presents case reports the methodology employed to analyze the results of the cases should be described in objective terms. Subjective assessments detract from the rating score. Duration of Study/Patient Follow-up: The length of the study should be stated. The study should be of sufficient length to adequately assess the effectiveness of the treatment against stated criteria. Studies in which the assessment interval is obviously inadequate for providing a valid assessment of treatment (eg, < I year) warrant an inadequate rating. The number of patients included at each assessment interval should be clearly stated. Subject Population, Inclusion Criteria: All criteria for selectin g patients to be included in the study should be specifically stated. Indications for the treatment under study should be stated . Subject Popukuion, Exclusion Criteria: All criteria for excluding patients from the stud y, either at the time of entry or during the course of the investigation, should be specifically stated. It should be clearly stated whether the selection of patients was consecutive or nonconsecutive; if a nonconsecutive series was employed the reasons should be stated . Identification oj Variables/Risk Factors: Those variables/risk factors which could effect outcome should be identified prospectively. Identification of OutcomeCriteria: Outcome criteria should be identified prospectively. Criteria should be described objectively and should be measurable. Retrospective analysis of outcomes and/or the inclusion of subjective criteria should detract from the rating score. Data Collection Methods: Th e manner in which data were collected , who collected the data, and how the data were prepared for analysis should be stated . Statistical Methods/Analysis: The methods ofdata anal ysis should be clearly described and include measures of significance. Methods used should be appropri ate for the study. The mann er of data presentation should be clear, concise, and understandable. Data from other published studies should not be included in the analysis unless a formal, recognized pooling methodology is employed. Conclusions Consistent With Data: The conclusions from the study and the discussion ofthe conclusions should be consistent with the data. Subjective interpretation of the results of the study independent of the collected data should detract from the rating score.