PMID- 31354252 OWN - NLM STAT- MEDLINE DCOM- 20191206 LR - 20231012 IS - 1178-1998 (Electronic) IS - 1176-9092 (Print) IS - 1176-9092 (Linking) VI - 14 DP - 2019 TI - Clinical performance of a bone-anchored annular closure device in older adults. PG - 1085-1094 LID - 10.2147/CIA.S208098 [doi] AB - 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. FAU - Bouma, Gerrit J AU - Bouma GJ AD - Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, Amsterdam, the Netherlands. FAU - Ardeshiri, Ardeshir AU - Ardeshiri A AD - Section for Spine Surgery, Klinikum Itzehoe, Itzehoe, Germany. FAU - Miller, Larry E AU - Miller LE AD - Miller Scientific Consulting, Asheville, NC, USA. FAU - Van de Kelft, Erik AU - Van de Kelft E AD - Department of Neurosurgery, AZ Nikolaas, Sint-Niklaas, Belgium. AD - Antwerp University, Antwerp, Belgium. FAU - Bostelmann, Richard AU - Bostelmann R AD - Department of Neurosurgery, University Clinic Dusseldorf, Duesseldorf, Germany. FAU - Klassen, Peter D AU - Klassen PD AD - Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany. FAU - Fluh, Charlotte AU - Fluh C AD - Department of Neurosurgery, University Medical Center Schleswig-Holstein, Kiel, Germany. FAU - Kursumovic, Adisa AU - Kursumovic A AD - Department of Neurosurgery, Donauisar Klinikum Deggendorf, Deggendorf, Germany. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20190619 PL - New Zealand TA - Clin Interv Aging JT - Clinical interventions in aging JID - 101273480 SB - IM MH - Adult MH - Age Factors MH - Aged MH - *Bone-Anchored Prosthesis MH - Disability Evaluation MH - Diskectomy/*methods/psychology MH - Female MH - Humans MH - Lumbar Vertebrae/*surgery MH - Male MH - Mental Health MH - Middle Aged MH - Pain/etiology MH - Registries MH - Reoperation MH - Sex Factors MH - Treatment Outcome PMC - PMC6590844 OTO - NOTNLM OT - annulus fibrosus OT - disc OT - elderly OT - herniation OT - lumbar OT - sciatica COIS- Dr Ardeshiri, Dr Miller, Dr Klassen, and Dr Kursumovic 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 Kursumovic reports personal fees from Intrinsic Therapeutics during the conduct of the study. The authors report no other conflicts on interest in this work. EDAT- 2019/07/30 06:00 MHDA- 2019/12/18 06:00 PMCR- 2019/06/19 CRDT- 2019/07/30 06:00 PHST- 2019/03/09 00:00 [received] PHST- 2019/05/14 00:00 [accepted] PHST- 2019/07/30 06:00 [entrez] PHST- 2019/07/30 06:00 [pubmed] PHST- 2019/12/18 06:00 [medline] PHST- 2019/06/19 00:00 [pmc-release] AID - 208098 [pii] AID - 10.2147/CIA.S208098 [doi] PST - epublish SO - Clin Interv Aging. 2019 Jun 19;14:1085-1094. doi: 10.2147/CIA.S208098. eCollection 2019.