Outcomes and Survivorship of Biomet Microfixation Total Joint Replacement System: Results From an FDA Postmarket Study.

PURPOSE: In February 2011, the Food and Drug Administration issued a postmarket surveillance order to all manufacturers of temporomandibular joint (TMJ) implants in the United States. The objective of the present study was to measure implant subsequent surgical intervention (SSI) among patients who had undergone TMJ reconstruction with the Biomet TMJ replacement system (Zimmer Biomet, Warsaw, IN). MATERIALS AND METHODS: A prospective observational study was conducted by sending a questionnaire to patients who had received a Biomet TMJ replacement system from 1995 to 2010 in the United States. The questionnaire was sent annually from 2012 to 2015. The primary endpoint was the SSIs. SSIs included both device removal and reoperations. Kaplan-Meier survival analysis was used to determine the survivorship, and Cox proportional hazard regression analysis was performed to evaluate the preoperative diagnosis and SSI. RESULTS: The mean age at implantation was 46.6 ± 12.5 years, with a gender distribution of 86.1% female. Data from 499 joints in 319 subjects were collected as a part of the survey. The mean follow-up time was 8.6 ± 3.9 years (range, 2-20 years). The first SSI frequency was 11.2% (4.2% removal rate and 7.0% reoperation rate). The survivorship rate (Kaplan-Meier) was 96% at 3 years, 94% at 5 years, and 86% at 10 years. The mean interval to failure using a survival function to determine the time to SSI (Greenwood's formula) was 13.5 ± 0.193 years. The most common causes of SSI included adhesion removal (2.6%; 13 of 498), heterotopic bone/ankylosis (2.0%; 10 of 498), and infection (1.6%; 8 of 498). CONCLUSIONS: The results from the present study are consistent with the reported survivorship rates for other orthopedic devices (5-year survival for total hip or knee arthroplasty, 95.9 and 97.2%, respectively). The etiology of SSIs in the Biomet TMJ replacement system was primarily secondary to biologic failure (ie, adhesions, heterotopic bone, and infection).

Microbiology Alloplastic Total Joint Infections: A 20-Year Retrospective Study.

PURPOSE: Prosthetic joint infection (PJI) is a rare complication of temporomandibular joint replacement (TJR). This study evaluated TJR PJIs at the authors' institution over a 20-year period, including micro-organisms cultured, antibiotic resistance patterns, and intraoperative protocols of TJR. PATIENTS AND METHODS: Patients were identified using Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes and surgical logs from January 1995 through 2015. Inclusion criteria were adults older than 18 years with previous alloplastic TJR and the presence of infection of the prosthesis at explantation. Exclusion criteria were patients younger than 18 years and who received hemiarthroplasty. Primary outcomes included culture data and antibiotic selection for PJI. Secondary outcomes included intraoperative duration and in vivo duration. RESULTS: Eleven patients were identified and 15 joints were explanted. Average length in vivo was 232 months (standard deviation, 478.9 months). Six percent (n = 1) were identified as early PJI (0 to 3 months), 46% (n = 7) were intermediate PJI (3 months to 2 yr), and 33% (n = 5) were late PJI (>2 yr). One patient could not be classified as early, intermediate, or late. Staphylococcus aureus was present in 53% of patients and was the predominant organism isolated. Propionibacterium acnes was isolated in 33% of patients. Penicillin was the antibiotic with the greatest organism resistance (46%). CONCLUSION: In the present study, the most commonly cultured organism was S aureus (53%), a finding consistent with current literature. The prevalence of P acnes colonization was noted in 33% of cases. Although the relevance of P acnes and its contribution to PJI requires further investigation, it is associated with PJI and biofilm formation. Based on this study, consideration could be given to the use of vancomycin and first-generation cephalosporins as perioperative antibiotic coverage.

Retrospective study of facial nerve function following temporomandibular joint arthroplasty using the endaural approach.

The aim of this retrospective case-control study is to evaluate the incidence of facial nerve injury associated with temporomandibular joint (TMJ) arthroplasty using the endaural approach for the treatment of TMJ pathology. The sample consisted of 36 consecutive patients who underwent TMJ arthroplasty. A total of 39 approaches were performed through an endaural incision. Patients undergoing total joint replacement and/or with preexisting facial nerve dysfunction were excluded from the study. Five patients were lost to follow-up and were excluded from the study. Facial nerve function of all patients was clinically evaluated by resident physicians preoperatively, postoperatively, and at follow-up appointments. Facial nerve injury was determined to have occurred if the patient was unable to raise the eyebrow or wrinkle the forehead (temporalis branch), completely close the eyelids (zygomatic branch), or frown (marginal mandibular branch). Twenty-one of the 36 patients or 22 of the 39 approaches showed signs of facial nerve dysfunction following TMJ arthroplasty. This included 12 of the 21 patients who had undergone previous TMJ surgery. The most common facial nerve branch injured was the temporal branch, which was dysfunctional in all patients either as the only branch injured or in combination with other branches. By the 18th postoperative month, normal function had returned in 19 of the 22 TMJ approaches. Three of the 22 TMJ approaches resulted in persistent signs of facial nerve weakness 6 months after the surgery. This epidemiological study revealed a low incidence of permanent facial nerve dysfunction. A high incidence of temporary facial nerve dysfunction was seen with TMJ arthroplasty using the endaural approach. Current literature reveals that the incidence of facial nerve injury associated with open TMJ surgery ranges from 12.5 to 32%. The temporal branch of the facial nerve was most commonly affected, followed by 4 of the 22 approaches with temporary zygomatic branch weakness. Having undergone previous TMJ surgery did not increase the incidence of facial nerve injury using the endaural approach. This information is important for patients and surgeons in the postoperative period, as a majority of patients will experience recovery of nerve function.

Pigmented villonodular synovitis of the temporomandibular joint.

Pigmented villonodular synovitis (PVNS) is a proliferative disorder that affects synovium-lined joints, bursae, and tendon sheaths. It appears in both diffuse and localized forms, depending on the extent of synovial involvement. PVNS rarely involves the temporomandibular joint (TMJ); when it does, it manifests clinically as a slowly growing and painless preauricular mass that resembles a parotid tumor. TMJ dysfunction, paresthesia, and/or hearing loss can result. We present a case of a large extra-articular PVNS of the TMJ, and we review the literature.

Biomet Microfixation Temporomandibular Joint Replacement System: a 3-year follow-up study of patients treated during 1995 to 2005.

PURPOSE: To assess the safety and efficacy of a stock alloplastic total temporomandibular joint (TMJ) implant system, the Biomet Microfixation TMJ Replacement System. MATERIALS AND METHODS: During a 10-year multicenter clinical trial from 1995 to 2005, 442 Biomet Microfixation TMJ Replacement Systems were implanted in 288 patients (154 bilaterally and 134 unilaterally). Patients were followed at landmark times, including the date of surgery and at 1 month, 3 months, 1 year, 1 year 6 months, and 3 years. The 3 major metrics that were evaluated were preoperative and postoperative pain, interference with eating, and maximal incisal opening. Paired t tests and comparison analyses were used to assess outcomes. RESULTS: There was statistically significant improvement in pain level (P = .0001), jaw function (P = .0001), and incisal opening (P = .0001). Although there were complications necessitating the removal of 14 of 442 implants (3.2%), there were no device-related mechanical failures. CONCLUSIONS: The clinical study presented supports the conclusion that a stock TMJ alloplastic replacement, based on sound orthopedic and biomedical principles, is a safe and efficacious option when alloplastic reconstruction of the TMJ is indicated.

Posttraumatic temporomandibular joint disorders.

The temporomandibular joint (TMJ) has many essential functions. None of its components are exempt from injury. Facial asymmetry, malocclusion, disturbances in growth, osteoarthritis, and ankylosis can manifest as complications from trauma to the TMJ. The goals of initial treatment include achievement of pretraumatic function, restoration of facial symmetry, and resolution of pain. These same objectives hold true for late repairs and reconstruction of the TMJ apparatus. Treatment is demanding, and with opposing approaches. The following article explores various treatment options for problems presenting as a result of a history of trauma to the TMJ.

Novel oral findings in Schimmelpenning syndrome.

We report a patient with Schimmelpenning syndrome with two previously unreported oral manifestations: multiple pigmented malformed teeth and an adenomatoid odontogenic tumor of the anterior mandible. Also found were multiple complex odontomas, bilateral maxillary fibro-osseous lesions and recurrent central giant cell granulomas of the jaws.

Severe proliferative congenital temporomandibular joint ankylosis: a proposed treatment protocol utilizing distraction osteogenesis.

The classical treatment for temporomandibular joint (TMJ) ankylosis in children: 1) joint release; 2) arthroplasty; 3) reconstruction; and 4) postoperative physical therapy (PT), is often unsuccessful. Postoperative physical therapy is difficult in the young patient due to poor cooperation. Moreover, there is a subgroup of patients who have a refractory congenital proliferative bony process that is the cause of their disease. In these patients, a role for distraction osteogenesis (DO) has been defined. We present a series of young patients with congenital proliferative TMJ ankylosis. Some have failed classic treatment. In such cases, DO is used to expand the mandibular size and soft tissue matrix. This creates a static open bite, facilitates mid-facial growth, and avoids compromise of the airway, speech, nutrition, and oral hygiene. To maintain these objectives, mandibular DO may be repeated as the child matures. Once skeletal maturity is reached, DO is used to normalize occlusion and further expand the soft tissue envelope prior to definitive reconstruction and aggressive post-op PT. In seven patients, this protocol has been used. Five patients are currently in the active phase of growth and undergoing interim treatment with mandibular DO. Two patients have reached skeletal maturity and have completed the protocol of DO with definitive arthroplasty and reconstruction. DO is a valuable aid in the treatment of the problematic child with congenital proliferative TMJ ankylosis. Interim DO, prior to definitive arthroplasty and reconstruction, can provide a static open bite that prevents progressive deformity and its associated functional disturbances.

Fluid and electrolyte management and blood product usage.

Traditionally, the majority of oral and maxillofacial surgery patients are young and healthy. With the ever-expanding scope of the specialty, however, more surgically extensive procedures increasingly are being performed on more medically complex patients. To optimize comprehensive patient care, oral and maxillofacial surgeons are obligated to possess a firm knowledge of the basic principles of fluid management and use a sound strategy for blood product usage.

Management of surgical failures.

Surgical intervention is appropriate in a small percentage of patients with temporomandibular joint disorders when it is based on a specific diagnosis of intracapsular pathology not amenable to nonsurgical modalities. Expected advances in our understanding of the complex molecular, biochemical, and genetic factors that influence these disease states clearly will allow less invasive techniques and even obviate the need for some open arthroplastic interventions altogether in the future. In the meantime, reasonable, well-intentioned surgeons must rely on the current body of surgical knowledge to use surgery as judiciously as possible.