Midterm osteolysis-induced aseptic failure of the M6-C™ cervical total disc replacement secondary to polyethylene wear debris

Background According to published meta-analyses, cervical total disc replacement (CTDR) seems to be superior to anterior cervical decompression and fusion (ACDF) in most clinical parameters. Despite short-term clinical success of CTDR, there are concerns regarding long-term durability of these prostheses. Methods This prospective study involved 382 patients who received standalone CTDR or a hybrid procedure (ACDF/CTDR). A retrospective comparison between different CTDR devices was conducted regarding patient-reported outcome measures (PROMs), failure scenarios, and revision surgeries. The M6-C™ Artificial Cervical Disc (Orthofix, Lewisville, Texas) cohort was compared to the other CTDR devices clinically. Etiological reasons for revision, and the surgical technique of the revision was investigated. Results Fifty-three patients received M6-C CTDR. Eighteen patients (34%) were revised at an average of 67 months postoperatively for wear-induced osteolysis. There were three additional cases of pending revision. The PROMs of the two groups were similar, indicating that the failure mode (wear-induced osteolysis) is often asymptomatic. The demographics of the two groups were also similar, with more women undergoing revision surgery than men. There were three one-level CTDR, four two-level hybrids, seven three-level hybrids, and three four-level hybrids revised anteriorly. Sixteen patients underwent removal of the prosthesis and were treated according to the extent of osteolysis. There were four vertebrectomies, six revisions to ACDF, and six revisions to another CTDR. One patient underwent supplemental fixation using a posterior approach. The other CTDR cohort had an incidence of 3.3% at the equivalent time, and none of these were due to osteolysis or wear-related events. Conclusions There is a concerning midterm failure rate related to ultra-high-molecular-weight-polyethylene wear-induced osteolysis in the M6-C. Patients implanted with the M6-C prosthesis should be contacted, informed, and clinically and radiologically assessed.

Investigation into Cervical Spine Biomechanics Following Single, Multilevel and Hybrid Disc Replacement Surgery with Dynamic Cervical Implant and Fusion: A Finite Element Study

Cervical fusion has been a standard procedure for treating abnormalities associated with the cervical spine. However, the reliability of anterior cervical discectomy and fusion (ACDF) has become arguable due to its adverse effects on the biomechanics of adjacent segments. One of the drawbacks associated with ACDF is adjacent segment degeneration (ASD), which has served as the base for the development of dynamic stabilization systems (DSS) and total disc replacement (TDR) devices for cervical spine. However, the hybrid surgical technique has also gained popularity recently, but its effect on the biomechanics of cervical spine is not well researched. Thus, the objective of this FE study was to draw a comparison among single-level, bi-level, and hybrid surgery with dynamic cervical implants (DCIs) with traditional fusion. Reductions in the range of motion (ROM) for all the implanted models were observed for all the motions except extension, compared to for the intact model. The maximum increase in the ROM of 42% was observed at segments C5–C6 in the hybrid DCI model. The maximum increase in the adjacent segment’s ROM of 8.7% was observed in the multilevel fusion model. The maximum von Mises stress in the implant was highest for the multilevel DCI model. Our study also showed that the shape of the DCI permitted flexion/extension relatively more compared to lateral bending and axial rotation.

Investigation Into Cervical Spine Biomechanics Following Single, Multilevel and Hybrid Disc Replacement Surgery With Dynamic Cervical Implant and Fusion: A Finite Element Study

Cervical fusion has been a standard procedure for treating the abnormalities associated with the cervical spine. However, the reliability of anterior cervical discectomy and fusion (ACDF) has become arguable due to its adverse effects on the biomechanics of adjacent segments. One of the drawbacks associated with ACDF is adjacent segment degeneration (ASD) which has served as the base for the development of dynamic stabilization systems (DSS) and total disc replacement (TDR) devices for cervical spine. However, the hybrid surgical technique has also gained popularity recently but their effect on the biomechanics of cervical spine is not well researched. Thus, the objective of this FE study was to draw the comparison among single, bi-level and hybrid surgery with DCI implant with traditional fusion. Reduction in range of motion (ROM) for all the implanted models was observed for all the motions except extension, compared to intact model. The maximum increase in ROM of 42% was observed at C5-C6 level in Hybrid-DCI model. The maximum increase in adjacent segment’s ROM of 8.7% was observed in multilevel fusion model. The maximum von Mises stress in the implant was highest for the multilevel DCI model. Our study also showed that the shape of DCI implant permits flexion/extension relatively more compared to lateral bending and axial rotation.