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      Feasibility of Non-window Three-Dimensional–Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Pilot Trial

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          Abstract

          Background

          The commercially available design of a three-dimensional (3D)–printed titanium (3D-Ti) cage can be divided into two types according to the presence of a window: a cage with a window that allows filling of bone graft materials and a non-window cage for stand-alone use. This prospective observational case series study aimed to explore the clinical feasibility of using a non-window type 3D-Ti cage in cases of combined window and non-window cage implantation. Furthermore, we evaluated the bone in growth patterns of non-window cages and their correlation with published fusion grading systems.

          Methods

          A total of 31 consecutive patients who underwent single-level posterior lumbar interbody fusion surgery were included. Two 3D-Ti cages with different designs were inserted: a non-window cage on the left side and a window cage on the right side. Radiographic fusion was defined by the segmental angle between flexion and extension radiographs (F-E angle) and cage bridging bone (CBB) scores on computed tomography. The association between the F-E angle and osteointegration scoring system including the surface osteointegration ratio (SOR) score was analyzed.

          Results

          Radiographic fusion was achieved in 27 of 31 patients (87%) at 12 months postoperatively. Among the non-window cages, 23 of 31 (74.2%) had fair SOR scores, while 19 of 31 (61.3%) window cages had fair intra-cage CBB scores. The higher the SOR score was, the smaller the flexion-extension angle (SOR 0 vs. SOR 1: 6.30° ± 2.43° vs. 1.95° ± 0.99°, p < 0.001; SOR 0 vs. SOR 2: 6.03° ± 2.43° vs. 0.99°± 0.74°, p < 0.001).

          Conclusions

          The clinical feasibility of using a non-window 3D-Ti cage during lumbar interbody fusion might be acceptable. Furthermore, a newly suggested fusion criterion for the use of the non-window cage, the SOR score, showed a significant association with the published fusion grading systems, demonstrating its feasibility in determining interbody fusion in lumbar spinal surgery.

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          Most cited references33

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          The Oswestry Disability Index.

          The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders. This review is based on publications using the ODI identified from the authors' personal databases, the Science Citation Index, and hand searches of Spine and current textbooks of spinal disorders. To review the versions of this instrument, document methods by which it has been validated, collate data from scores found in normal and back pain populations, provide curves for power calculations in studies using the ODI, and maintain the ODI as a gold standard outcome measure. It has now been 20 years since its original publication. More than 200 citations exist in the Science Citation Index. The authors have a large correspondence file relating to the ODI, that is cited in most of the large textbooks related to spinal disorders. All the published versions of the questionnaire were identified. A systematic review of this literature was made. The various reports of validation were collated and related to a version. Four versions of the ODI are available in English and nine in other languages. Some published versions contain misprints, and many omit the scoring system. At least 114 studies contain usable data. These data provide both validation and standards for other users and indicate the power of the instrument for detecting change in sample populations. The ODI remains a valid and vigorous measure and has been a worthwhile outcome measure. The process of using the ODI is reviewed and should be the subject of further research. The receiver operating characteristics should be explored in a population with higher self-report disabilities. The behavior of the instrument is incompletely understood, particularly in sensitivity to real change.
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            Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up.

            Anterior cervical discectomy and fusion (ACDF) with titanium- or polyetheretherketone (PEEK)-cage reconstruction is widely used in the treatment of cervical spondylotic myelopathy (CSM). This study was to compare outcomes of titanium and PEEK cages in the treatment of multilevel CSM. Between November 2002 and December 2004, a total of 80 patients with 3-level CSM were randomized in a 1:1 ratio to titanium group and PEEK group. The overall follow-up period of the patients ranged from 86 to 116 months (average 99.7 months). Clinical and radiological results were compared between titanium group and PEEK group. At the final follow-up, the clinical outcomes including JOA score, NDI score, and the excellent and good rates of clinical outcomes in the PEEK group were better than those in the titanium group. More loss of the Cobb angles and the intervertebral height was observed in the titanium group, resulting in the radiological parameters in the titanium group becoming inferior to the PEEK group at the final follow-up. Cage subsidence rates were 34.5 and 5.4% in the titanium and PEEK groups, respectively. Fusion was observed in all patients of two groups at the final follow-up. Two patients presented with cage dislocation without clinical symptoms in the titanium group. In surgical treatment of multilevel CSM, PEEK cage is superior to titanium cage in maintenance of intervertebral height and cervical lordosis, resulting in better clinical outcomes in the long-term follow-up.
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              A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage.

              A prospective, concurrently controlled, randomized, multicenter trial of an anterior Bagby and Kuslich cervical fusion cage (BAK/C; Sulzer Spine-Tech, Minneapolis, MN) for treatment of degenerative disc disease of the cervical spine. To report clinical results with maximum 24-month follow-up of fusions performed with the BAK/C fusion cage. Threaded lumbar cages have been used during the past decade as a safe and effective surgical solution for chronic disabling low back pain. Threaded cages have now been developed for use in anterior cervical interbody fusions to obviate the need for allografts or autogenous bone grafting procedures while providing initial stability during the fusion process. Patients with symptomatic cervical discogenic radiculopathy were treated with either anterior cervical discectomy with uninstrumented bone-only fusion (ACDF) or BAK/C fusion cage(s). Independent radiographic assessment of fusion was made and patient-based outcome was assessed by visual analog pain scale and a Short Form (SF)-36 Health Status Questionnaire. Data analysis included 344 patients at 1 year and 180 at 2 years. When the two cage groups (hydroxya, patite-coated or noncoated) were compared with the ACDF group, similar outcomes were noted for duration of surgery, hospital stay, improvements in neck pain and radicular pain in the affected limb, improvements in the SF-36 Physical Component subscale and Mental Component subscale, and the patients' perception of overall surgical outcome. Symptom improvements were maintained at 2 years. A greater percentage of patients with ACDF needed an iliac crest bone harvest than did BAK/C patients (67% vs.- 3%). Successful fusion for one-level procedures at 12 months was 97.9% for the BAK/C groups and 89.7% for the ACDF group (P < 0.05). The complication rate for the ACDF group was 20.4% compared with an overall complication rate of 11.8% with BAK/C. There was no difference in complications that necessitated a second operative procedure. These results demonstrate that outcomes after a cervical fusion procedure with a threaded cage are the same as those of a conventional uninstrumented bone-only anterior discectomy and fusion with a low risk of complications and rare need for autogenous bone graft harvest.
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                Author and article information

                Journal
                Clin Orthop Surg
                Clin Orthop Surg
                CIOS
                Clinics in Orthopedic Surgery
                The Korean Orthopaedic Association
                2005-291X
                2005-4408
                December 2023
                01 September 2023
                : 15
                : 6
                : 960-967
                Affiliations
                Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.
                [* ]Department of Orthopedic Surgery, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
                []Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, Goyang, Korea.
                Author notes
                Correspondence to: Kwang-Sup Song, MD. Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul 06973, Korea. Tel: +82-2-6299-1589, Fax: +82-2-822-2017, ksong70@ 123456cau.ac.kr
                Author information
                https://orcid.org/0000-0003-4278-2701
                https://orcid.org/0000-0003-0570-160X
                https://orcid.org/0000-0001-6731-1063
                https://orcid.org/0000-0002-7904-2638
                https://orcid.org/0000-0002-9238-8908
                Article
                10.4055/cios22404
                10689219
                38045587
                45e6c89d-75c4-41b1-a231-8facd5c03938
                Copyright © 2023 by The Korean Orthopaedic Association

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 30 December 2022
                : 25 April 2023
                : 28 April 2023
                Categories
                Original Article

                Surgery
                titanium,printing,lumbar surgery,spinal fusion,osseointegration
                Surgery
                titanium, printing, lumbar surgery, spinal fusion, osseointegration

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