Abstract

<h3>BACKGROUND CONTEXT</h3> Many patients with symptomatic lumbar degenerative disc disease (DDD) are affected at more than one level. When nonoperative treatment fails to provide adequate relief, multilevel surgery may be considered. Lumbar total disc replacement (TDR) was introduced as an option to fusion. Some disc levels are not amenable to TDR and fusion is preferable at that level. Hybrid surgery, involving TDR at one level and fusion at the adjacent segment, has been introduced as an option to fusing multiple levels. <h3>PURPOSE</h3> The purpose of this study was to investigate the long-term clinical outcome of patients undergoing lumbar hybrid surgery for treating symptomatic lumbar DDD at more than one level. <h3>STUDY DESIGN/SETTING</h3> The study was a retrospective record review combined with a mailing and/or telephone calls to patients to collect current outcome data. <h3>PATIENT SAMPLE</h3> A consecutive series of 296 patients undergoing lumbar hybrid surgery was identified beginning with the first case experience in 2005. All patients were treated for painful disc degeneration unresponsive to nonoperative care and were at least two years postoperative. <h3>OUTCOME MEASURES</h3> The primary outcome measures were visual analog scales (VAS) separately assessing back and leg pain, and the Oswestry Disability Index (ODI). Data on re-operations were also collected. <h3>METHODS</h3> General descriptive data, surgical data and outcomes were collected for the consecutive series of hybrid patients. For patients who had not been seen recently in the clinic, mailing and/or telephone calls were conducted to collect VAS, ODI, and re-operation data. <h3>RESULTS</h3> The mean follow-up duration was 71.4 months with a maximum of 196 months. A total of 649 levels were operated with TDR implanted in 318 levels and 331 levels undergoing either stand-alone ALIF or combined anterior/posterior fusion. The most common combination for hybrid surgery was TDR at L4-5 and fusion at L5-S1. The mean blood loss was 99.1 ml. There were statistically significant improvements (p <0.001) in the mean values of all three clinical <h3>OUTCOME MEASURES</h3> VAS back pain scores improved from 6.7 to 3.2; VAS leg pain scores improved from 4.2 to 2.0; and ODI scores improved from 45.7 to 25.4. There were no significant differences in the pain and function scores for patients with minimum 10-year follow-up vs those with shorter follow-up duration. Re-operation occurred in 16.2% of patients. The most common reason for re-operation was the removal of painful posterior instrumentation at the fusion level of the hybrid (31.3% of re-operations; 6.1% of the study group). Re-operations involving the TDR level occurred in 9 patients (3.0%). These included 3 cases of TDR migration, 1 posterior fusion for facet joint arthrosis, 4 patients underwent decompression at the TDR and fusion levels, and one patient underwent re-operations at both hybrid levels related to multilevel deformity. One patient reported multiple re-operations on the returned mailing, but insufficient detail was provided to determine the procedure(s) performed. <h3>CONCLUSIONS</h3> The results of this study support that for many patients with symptomatic DDD arising from more than one disc, hybrid surgery is a viable surgical option. Significant improvement was demonstrated in pain and function scores with no difference in scores among patients with more than 10-year follow-up. The most commonly occurring re-operation was removal of painful posterior fixation, unrelated to the TDR. <h3>FDA DEVICE/DRUG STATUS</h3> Charite, ProDisc-L, activL (Not approved for this indication)

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