![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Background: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear.
Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results.
Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries.
Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.
Acknowledgment
There were no contributors to the article other than the authors. No writing assistance regarding this study was received.
Abbreviation list
ACD, annular closure device; MCID, minimal clinically important difference; MCS, Mental Component Summary; ODI, Oswestry Disability Index; PCS, Physical Component Summary.
Data sharing statement
All authors have agreed to the submission and publication of this manuscript. The authors confirm that requests for data underlying the findings described in this manuscript may be made to the corresponding author starting 1 year following publication of this article.
Supplementary material
Table 1 Preoperative characteristics of older versus younger patients treated with lumbar discectomya
Table 2 Predictors of symptomatic reherniation and reoperation risk over 3 years after lumbar discectomy
Table 3 Results of annular closure device postmarket registries by age group
Table S1 List of participating centers and patient enrollment totals
Author Contributions
All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
Dr Ardeshiri, Dr Miller, Dr Klassen, and Dr Kuršumović disclose consultancy with Intrinsic Therapeutics. Dr Ardeshiri reports personal fees and non-financial support from Intrinsic Therapeutics outside the submitted work. Dr Miller reports personal fees from Intrinsic Therapeutics during the conduct of the study. Dr Klassen reports personal fees from Intrinsic Therapeutics and non-financial support from Intrinsic Therapeutics during the conduct of the study. Dr Kuršumović reports personal fees from Intrinsic Therapeutics during the conduct of the study. The authors report no other conflicts on interest in this work.