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The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 157 - 163
1 Jan 2021
Takenaka S Kashii M Iwasaki M Makino T Sakai Y Kaito T

Aims

This study, using a surgeon-maintained database, aimed to explore the risk factors for surgery-related complications in patients undergoing primary cervical spine surgery for degenerative diseases.

Methods

We studied 5,015 patients with degenerative cervical diseases who underwent primary cervical spine surgery from 2012 to 2018. We investigated the effects of diseases, surgical procedures, and patient demographics on surgery-related complications. As subcategories, the presence of cervical kyphosis ≥ 10°, the presence of ossification of the posterior longitudinal ligament (OPLL) with a canal-occupying ratio ≥ 50%, and foraminotomy were selected. The surgery-related complications examined were postoperative upper limb palsy (ULP) with a manual muscle test (MMT) grade of 0 to 2 or a reduction of two grade or more in the MMT, neurological deficit except ULP, dural tear, dural leakage, surgical-site infection (SSI), and postoperative haematoma. Multivariate logistic regression analysis was performed.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 86 - 86
1 Dec 2020
Bal Z Kaito T Ishiguro H Okada R Kanayama S Kushioka J Kodama J Chijimatsu R Korkusuz P Dede EÇ Gizer M Yoshikawa H Korkusuz F
Full Access

To prevent the reported side effects of rhBMP-2, an important cytokine with bone forming capacity, the sustained release of rhBMP-2 is highly important. Synthetic copolymer polylactic acid-polyethylene glycol (PLA-PEG) is already shown to be a good carrier for rhBMP-2. The nano-sized hydroxyapatite (nHAp) is mentioned to be superior to conventional hydroxyapatite due to its decreased particle size which increases the surface area, so protein-cell adhesion and mechanical properties concomitantly. In the literature no study is reported with PLA-PEG / rhBMP-2/ nHAp for bone regeneration. In this study, we assessed the controlled release profile of rhBMP-2 from the novel biomaterial of PLA-PEG / rhBMP-2 / nHAp in vitro and evaluated the bone forming capacity of the composite in rat posterolateral spinal fusion (PSF) model in vivo.

Composites were prepared via addition of rhBMP-2 (0µg, 3µg or 10µg) and nHAp (12.5mg) into PLA-PEG (5mg) + acetone solution and shaping. The release kinetics of the cytokine from the composites with 5µg BMP-2 was investigated by ELISA. The effect of nHAp and nHAp with rhBMP-2 on cell differentiation (rat BMSC cells, passage 3) was tested with ALP staining. In vivo bone formation was investigated by PSF on L4-L5 in a total of 36 male SD rats and weekly µCT results and histology at 8th weeks post operation were used for assessment of the bone formation. All animal experiments was approved by the institutional review board confirming to the laws and regulations of Japan.

The composite showed an initial burst release in the first 24 hours (51.7% of the total released rhBMP-2), but the release was continued for the following 21 days. Thus, the sustained release of rhBMP-2 from the composite was verified. ALP staining results showed nHAp with rhBMP-2 contributed better on differentiation than nHAp itself. µCT and histology demonstrated that spinal fusion was achieved either one or both transverse processes in almost all BMP 3µg and BMP 10µg treated animals. On the contrary, only small or no bone formation was observed in the BMP0µg group (bilateral non-union / unilateral fusion/ bilateral fusion, BMP0µg group; 9/0/0, BMP3µg group; 1/0/11, BMP10µg group; 0/1/11).

We developed a new technology for bone regeneration with BMP-2/PLA-PEG/nHAp composite. With this composite, the required dose of BMP-2 for spinal fusion in rats (10µg) was decreased to 1/3 (3µg) which can be explained by the superior properties of nano-sized hydroxyapatite and by the achievement of sustainable release of rhBMP-2 from the composite.

This study is supported by Japanese Society of the Promotion of Science (JSPS) and Scientific and Technological Research Council of Turkey (TUBITAK). [Project No: 215S834]


The Bone & Joint Journal
Vol. 101-B, Issue 9 | Pages 1115 - 1121
1 Sep 2019
Takenaka S Makino T Sakai Y Kashii M Iwasaki M Yoshikawa H Kaito T

Aims

The aim of this study was to explore risk factors for complications associated with dural tear (DT), including the types of DT, and the intra- and postoperative management of DT.

Patients and Methods

Between 2012 and 2017, 12 171 patients with degenerative lumbar diseases underwent primary lumbar spine surgery. We investigated five categories of potential predictors: patient factors (sex, age, body mass index, and primary disease), surgical factors (surgical procedures, operative time, and estimated blood loss), types of DT (inaccessible for suturing/clipping and the presence of cauda equina/nerve root herniation), repair techniques (suturing, clipping, fibrin glue, polyethylene glycol (PEG) hydrogel, and polyglycolic acid sheet), and postoperative management (drainage duration). Postoperative complications were evaluated in terms of dural leak, prolonged bed rest, headache, nausea/vomiting, delayed wound healing, postoperative neurological deficit, surgical site infection (SSI), and reoperation for DT. We performed multivariable regression analyses to evaluate the predictors of postoperative complications associated with DT.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 28 - 28
1 Nov 2018
Bal Z Kaito T Ishiguro H Korkusuz P Dede E Korkusuz F
Full Access

Sustained release of BMP-2 is reported to be able to reduce the required dose of BMP-2 for bone induction. Nanohydroxyapatite (nHAp) has an osteoinduction capability which is lack in conventional hydroxyapatite. In this study, we combined PLA-PEG with nHAp and investigated the bone regenerative capacity of the newly established composite material of rhBMP-2/PLA-PEG/nHAp in a rat model of spinal fusion. The PLA-PEG was liquidized in acetone and mixed with nHAp and rhBMP-2. The sheet-shaped BMP-2/PLA-PEG (5mg)/nHAp (12.5mg) composites were prepared while evaporating the acetone. The release kinetics of rhBMP-2 from the composite was investigated by ELISA. In vivo bone formation was investigated by posterolateral spinal fusion in rats (the dosage of rhBMP-2; 0µg/ 0.5µg / 3µg). Bone formation was assessed by µCT and histology at post-op. 8 weeks. The composite showed the burst-release in the initial 24 hours (69% of total release) and the subsequent sustained-release for 25 days. According to µCT and histology of the spinal fusion experiment for all groups the bone formation was observed. While no bony bridging was observed in 0 µg and 0.5 µg BMP groups; in 3 µg group bony bridging and fusion were achieved. We developed a new technology for bone regeneration with rhBMP-2/PLA-PEG/nHAp composite. The reduction in the required dose of BMP-2 for bone induction was achieved. This result can be explained by the high bone induction ability of nHAp and sustainable release of BMP from PLA-PEG in the composite.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 990 - 996
1 Jul 2016
Fujiwara H Makino T Yonenobu K Honda H Kaito T

Aims

In this prospective observational study, we investigated the time-dependent changes and correlations of upper arm performance tests (ten-second test and Simple Test for Evaluating Hand Function (STEF), the Japanese Orthopaedic Association (JOA) score, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) in 31 patients with cervical myelopathy who had undergone surgery.

Patients and Methods

We hypothesised that all the indices correlate with each other, but show slightly different recovery patterns, and that the newly described JOACMEQ is a sensitive outcome measure.


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 666 - 671
1 May 2016
Makino T Kaito T Sakai Y Kashii M Yoshikawa H

Aims

To clarify the asymmetrical ossification of the epiphyseal ring between the convex and concave sides in patients with adolescent idiopathic scoliosis (AIS).

Patients and Methods

A total of 29 female patients (mean age, 14.4 years; 11 to 18) who underwent corrective surgery for AIS (Lenke type 1 or 2) were included in our study. In all, 349 vertebrae including 68 apical vertebrae and 87 end vertebrae in the main thoracic (MT) curve and thoracolumbar/lumbar (TL/L) curve were analysed. Coronal sections (anterior, middle and posterior) of the vertebral bodies were reconstructed from pre-operative CT scans (320-row detector; slice thickness, 0.5 mm) and the appearances of the ossification centre in the epiphyseal ring at four corners were evaluated in three groups; all vertebrae excluding end vertebrae, apical vertebrae and end vertebrae. The appearance rates of the ossification centre at the concave and convex sides were calculated and compared.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 9 | Pages 1210 - 1213
1 Sep 2008
Hosono N Sakaura H Mukai Y Kaito T Makino T Yoshikawa H

We evaluated 30 patients with cervical myelopathy before and after decompressive surgery and compared them with 42 healthy controls. All were asked to grip and release their fingers as rapidly as possible for 15 seconds. Films recorded with a digital camera were divided into three files of five seconds each. Three doctors independently counted the number of grip and release cycles in a blinded manner (N1 represents the number of cycles for the first five-second segment, N2 for the second and N3 for the third). N2 and N3 of the pre-operative group were significantly fewer than those of the control group, and the postoperative group’s results were significantly greater than those of the pre-operative group. In the control group, the numbers decreased significantly with each succeeding five-second interval (fatigue phenomenon). In the pre-operative myelopathy group there was no significant difference between N1 and N2 (freezing phenomenon).

The 15-second test is shown to be reliable in the quantitative evaluation of cervical myelopathy. Although it requires a camera and animation files, it can detect small changes in neurological status because of its precise and objective nature.