TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System: Results from an FDA Post-Market Surveillance Prospective Cohort Study

Abstract

BackgroundCustom-designed and patient-fitted temporomandibular joint replacement devices (TMJR) are employed to manage end-stage TMJ pathology, distorted bony TMJ architecture, or in patients who have undergone multiple prior failed TMJ surgeries. PurposeThis study aimed to measure the frequency of revision or replacement over time, estimate the 1, 2, and 3-year survival rate of implants, and determine what demographic, anatomical, or operative variables may be associated with a device adverse event. Study design, setting, and sampleA prospective cohort study was conducted on consenting adults who could read English, implanted with the TMJ Concepts TMJR prostheses between 2013 and 2015 by private or academic surgeons. Patients under the age of 18 and those who were incapable, unwilling, or unable to complete the perioperative forms were excluded. Outcome variablesThe primary outcome variable was the frequency of adverse events, which is defined as device revision or replacement. The secondary outcome variable was the survival rate for the TMJ Concepts devices. AnalysesDevice survival at 1, 2, and 3 years was estimated using the Kaplan-Meyer methodology. Cox proportional hazards regression was used to analyze the effects of the predictor variables for the device survival rate. A p-value of <0.05 was considered significant. ResultsA total of 738 subjects (1098 joints) were enrolled in the study with 102 (14%) males and 636 (86%) females. The mean age was 45.4 (+ 14.8) years. The median follow-up period was 36.2 months (95% CI: 36.1 – 36.2 months). A total of 187 subjects (25.3%) were lost to follow-up during; the study period. Forty-nine devices (4.46%) were associated with an adverse event at 3 years. The; 3-year device survival was 95.1 % (95% CI: 93.6 – 96.3%). The only significant risk factor for an adverse event was the asymmetry of the mandible (hazard rate ratio = 1.989, p = 0.03). The primary diagnosis was not associated with the time to an adverse event (p-value = 0.8685). Infection (44.7 %, 21 joints) and material sensitivity (12.8 %, 6 joints) were the most common reasons specifically for device removal/replacement in the study cohort. ConclusionsInfection was the primary reason reported for device revision or replacement followed by material sensitivity. In the study cohort, the device survival following implantation of the TMJ Concepts prosthesis was not significantly different than reported by the TMJR stock device.