Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

2021 ◽  
pp. 1-9

OBJECTIVE Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent-segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP? METHODS This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was graded according to the Miyazaki classification system. RESULTS Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI −5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21). CONCLUSIONS This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior decompression for cervical degenerative radiculopathy.

2015 ◽  
Vol 15 (10) ◽  
pp. S129
Author(s):  
Jeffrey M. Spivak ◽  
Jack E. Zigler ◽  
Michael E. Janssen ◽  
Bruce V. Darden ◽  
Kris E. Radcliff

2019 ◽  
Vol 30 (3) ◽  
pp. 323-331 ◽  
Author(s):  
Anna MacDowall ◽  
Nuno Canto Moreira ◽  
Catarina Marques ◽  
Martin Skeppholm ◽  
Lars Lindhagen ◽  
...  

OBJECTIVEThe method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, long-term follow-up evaluations using MRI are needed to investigate if this intent is achieved.METHODSThe authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.RESULTSScores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.CONCLUSIONSIn patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.Clinical trial registration no.: 44347115 (ISRCTN).


2012 ◽  
Vol 12 (9) ◽  
pp. S62 ◽  
Author(s):  
Jeffrey M. Spivak ◽  
Rick B. Delamarter ◽  
Daniel B. Murrey ◽  
Jack E. Zigler ◽  
Michael E. Janssen ◽  
...  

2014 ◽  
Vol 21 (6) ◽  
pp. 949-953 ◽  
Author(s):  
Gregory M. Malham ◽  
Rhiannon M. Parker ◽  
Ngaire J. Ellis ◽  
Philip G. Chan ◽  
Dinesh Varma

2020 ◽  
pp. 219256822093581
Author(s):  
Joep Kitzen ◽  
Timon F. G. Vercoulen ◽  
Martijn G. M. Schotanus ◽  
Sander M. J. van Kuijk ◽  
Nanne P. Kort ◽  
...  

Study Design: Retrospective cohort study. Objectives: Total disc replacement (TDR) has been introduced in order to preserve segmental motion and thus reduce adjacent segment disease (ASD) as seen after spinal fusion. However, it is uncertain whether these presumed beneficial effects remain. The aim of this study was to evaluate the long-term incidence of ASD and residual-mobility in relation to clinical outcome. Methods: A total of 210 patients treated with lumbar TDR for degenerative disc disease were invited for follow-up. ASD was reported in case of severe degeneration in an adjacent disc at latest follow-up, or if an increase in disc degeneration was observed in these adjacent segments as compared to direct postoperative radiographs. Residual-mobility of the TDR was defined as a minimal rotation of 4.6° on flexion-extension radiographs. Patient-reported outcome measures were obtained. Results: Fifty-seven patients (27.1%) were lost to follow-up. In 32 patients (15.3%) a revision by spinal fusion had been performed. In 20 patients this revision had occurred ≥5 years after TDR and were included. Consequently, 141 patients were available for analysis (mean follow-up of 16.7 years). Residual-mobility was noted in 38.0%. No significant associations were observed between residual-mobility and the occurrence of ASD, or with clinical outcome. In addition, ASD and clinical outcome were not related either. Conclusions: It appears that long-term preservation of motion after TDR is met for only a third of patients. However, residual-mobility is not associated with the occurrence of ASD, and both residual-mobility and ASD do not appear to be related to long-term clinical outcome.


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