Clinical significance of heterotopic ossification in cervical disc replacement: A prospective multicenter clinical trial

OBJECTIVE: Heterotopic ossification (HO) is a well-known complication in joint replacements, but its occurrence and clinical effect on cervical artificial discs has not yet been studied. The purpose of this study was to investigate the incidence of HO in cervical disc replacement, to identify any associated risk factors for HO, and to examine the relationship of HO with clinical outcomes. METHODS: The patient data for this observational study were obtained from the original Bryan Disc Study by the European Consortium. Occurrence of HO was defined by the McAfee classification on the cervical lateral x-rays at 12 months after Surgery. Secondary Outcome measurements included Odom's criteria and the Medical Outcomes Study Short-Form 36-Item Health Survey. RESULTS: Sixteen (17.8%) of the 90 Studied patients experienced HO, and 6 (6.7%) of these patients experienced Grade 3 and 4 HO. Ten patients' (11%) artificial discs were shown to have movement of less than 2 degrees on flexion and extension cervical x-ray at 12 months, with 4 of these patients having HO of Grade 3 or 4. Male sex (chi(2) = 4.1; P = 0.0407) and older patients (P = 0.023; odds ratio = 1.10; 95% confidence interval = 1.01-1.19) were associated with development of HO. CONCLUSION: There is a strong association of the occurrence of HO with subsequent loss of movement of the implanted cervical artificial disc. We have found that sex and age are two possible risk factors in the development of HO after cervical disc replacement.