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1.
Med Eng Phys ; 120: 104056, 2023 10.
Article in English | MEDLINE | ID: mdl-37838405

ABSTRACT

This study presents a laser guidance system developed to enhance surgical accuracy and reduce radiation exposure in orthopedic surgeries. The system can project the actual position corresponding to the appointed position selected by the surgeon on a fluoroscopic image using a line laser and has laser projection ability to mark the corresponding point using a line laser. The surgeon does not have to perform anatomical marker placement for calibration. Three patients with bone tumors underwent surgeries using the laser guidance system, and the projection accuracy was evaluated by measuring the distance error between the appointed and laser-marking positions. The installation time, including calibration, was also assessed for clinical usability. The average projection accuracy in bone tumor surgery was 2.86 mm, and the average installation time was 7 min. These results demonstrate that the laser guidance system, with a projection error of <3 mm, could be useful in bone tumor surgeries.


Subject(s)
Bone Neoplasms , Orthopedic Procedures , Surgery, Computer-Assisted , Humans , Surgery, Computer-Assisted/methods , Lasers , Orthopedic Procedures/methods , Bone Screws , Fluoroscopy/methods , Bone Neoplasms/diagnostic imaging , Bone Neoplasms/surgery
2.
Spine J ; 21(9): 1580-1586, 2021 09.
Article in English | MEDLINE | ID: mdl-33872804

ABSTRACT

OBJECTIVES: To evaluate the differences in the pullout strength and displacement of pedicle screws in cadaveric thoracolumbar vertebrae with or without artificial demineralization. METHODS: Five human lumbar and five thoracic vertebrae from one cadaver were divided into two hemivertebrae. The left-side specimens were included in the simulated osteopenic model group and the right-side bones in a control group. In the model group, we immersed each specimen in HCl (1 N) solution for 40 minutes. We measured bone mineral density (BMD) using dual-energy X-ray absorptiometry and quantitative computerized tomography. We inserted polyaxial pedicle screws into the 20 pedicles of the cadaveric lumbar and thoracic spine after measuring the BMD of the 2 hemivertebrae of each specimen. We measured the pullout strength and displacement of the screws before failure in each specimen using an Instron system. RESULTS: The average pullout strength of the simulated osteopenic model group was 76% that of the control group. In the control and model groups, the pullout strength was 1678.87±358.96 N and 1283.83±341.97 N, respectively, and the displacement was 2.07±0.34 mm and 2.65±0.50 mm, respectively (p<.05). We detected positive correlations between pullout strength and BMD in the control group and observed a negative correlation between displacement and BMD in the model group. CONCLUSIONS: By providing an anatomically symmetric counterpart, the human cadaveric model with or without demineralization can be used as a test bed for pullout tests of the spine. In the simulated osteopenic model group, pullout strength was significantly decreased compared with the untreated control group. CLINICAL SIGNIFICANCE: Decreased bone mineral density may significantly reduce the pullout strength of a pedicle screw, even though the range is osteopenic rather than osoteoporotic.


Subject(s)
Pedicle Screws , Biomechanical Phenomena , Bone Density , Cadaver , Humans , Lumbar Vertebrae/surgery , Thoracic Vertebrae/surgery
3.
Injury ; 52(7): 1673-1678, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33906742

ABSTRACT

INTRODUCTION: As most patients with polytrauma or open fractures are converted from temporary external fixation to definite stabilization, the prevention of complications such as infection is especially important. To overcome the high risk of infection associated with the use of the conventional bicortical pin for temporary external fixation, the authors developed a novel unicortical pin and analyzed it in a biomechanical study. METHODS: The unicortical pin consisted of an inner screw, purchasing the cortical bone, and an outer sleeve with 6 spikes. A bicortical pin was used for the purpose of comparison. A fracture gap model was stabilized using a monoplanar configuration. Both the unicortical pins (Uni group) and bicortical pins (Bi group) underwent axial compressive and torsional load testing using a servo-hydraulic testing machine. Stiffness, load to failure, and mode of failure were documented. RESULTS: Stiffness and load to failure of the Uni group (average, 40.5 N/mm and 1098.4 N, respectively) were greater than that of the Bi group (average, 33.7 N/mm and 968.6 N, respectively) in the axial compressive load test (P = 0.008 and 0.032). Stiffness and load to failure of the Uni group (average, 1.2 Nm/degree and 1.7 Nm, respectively) were also significantly higher than those of the Bi group (average, 0.8 Nm/degree and 0.6 Nm, respectively) in the torsional load test (P = 0.008 and 0.016). All pins in the Bi group were bent at the pin-synthetic bone interface without synthetic bone failure. Contrarily, the Uni group did not show any pin bending or failure. However, in the axial compression test, partial cracks in the synthetic bone were found at the interface with spikes in the outer shell. In addition, in the torsion test, incomplete fractures were seen through the inner screws' holes. CONCLUSION: Compared with the conventional bicortical pin, the newly designed unicortical pin significantly increased fracture stability under both axial compressive and torsional loads. The unicortical pin can be considered an alternative biomechanical solution to obtain adequate stability when performing external fixation of fractures.


Subject(s)
Bone Plates , External Fixators , Biomechanical Phenomena , Fracture Fixation , Fracture Fixation, Internal , Humans
4.
Injury ; 50(10): 1593-1598, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31288939

ABSTRACT

INTRODUCTION: Lateral locked plating is a standard treatment option for distal femur fractures. However, the unstable conditions after lateral locked plating are increasing. The objective of this study was to investigate the biomechanical strength of additional medial plate fixation over the unstable lateral locked plating of distal femur fractures. MATERIALS AND METHODS: A distal femur fracture model (AO/OTA 33-A3) was created with osteotomies in the composite femur. Three study groups consisting of 6 specimens each were created for single-side lateral locked plating with 6 distal locking screws (LP-6), single-side lateral locked plating with 4 distal locking screws (LP-4), and additional medial locked plating on LP-4 construct (DP-4). A compressive axial load (10 mm/min) was applied in the failure test. Mode of failure, load to failure, and ultimate displacement were documented. RESULTS: All single-side lateral locked plating (LP-4 and LP-6) showed plate bending at the fracture gap, while none of the DP-4 showed plate bending at the fracture gap. Load to failure of DP-4 (mean 5522 N) was 17.1% greater than that of LP-6 (mean 4713.3 N, p < 0.05) and 29.2% greater than that of LP-4 (mean 4273.2 N, p < 0.05). Ultimate displacement of DP-4 (mean 5.6 mm) was significantly lower than that of LP-6 (mean 8.8 mm, p < 0.05) and LP-4 (mean 9.1 mm, p < 0.05). CONCLUSIONS: Additional fixation of medial plate significantly increased the fracture stability in distal femur fractures fixed with the lateral locked plating. Especially in the clinical situations where sufficient stability cannot be provided at the distal segment, the medial plate may be considered as a useful biomechanical solution to obtain adequate stability for fracture healing.


Subject(s)
Bone Substitutes , Femoral Fractures/surgery , Fracture Fixation, Internal/instrumentation , Tensile Strength/physiology , Weight-Bearing/physiology , Biomechanical Phenomena , Bone Plates , Bone Screws , Compressive Strength , Equipment Design , Humans , Materials Testing , Stress, Mechanical
5.
J Knee Surg ; 32(9): 841-846, 2019 Sep.
Article in English | MEDLINE | ID: mdl-30189435

ABSTRACT

The purpose of this study was to evaluate the usefulness of a three-dimensional (3D) printed model for open-wedge high tibial osteotomy (HTO). This study retrospectively evaluated 20 patients with medial knee osteoarthritis and varus deformity. Between October 2015 and July 2016, the patients underwent open-wedge HTO using a 3D printed model. The mean age of patients was 55.2 years (range, 51-60 years). The mean preoperative mechanical femorotibial angle (mFTA) was varus 7.8 degrees (range, varus 4.7-11.6 degrees). After measuring the target angle using full-length lower limb weight-bearing radiography, the osteotomy was simulated using 3D images obtained from computed tomography (CT) with the 3D Slicer program. On the basis of the simulated osteotomy section and the target angle, the model was then designed and printed. Open-wedge HTO was then performed by applying the 3D printed model to the opening gap. The accuracy of osteotomy and the change in posterior tibial slope (PTS) angle were evaluated. The weight-bearing line on the tibial plateau was corrected from a preoperative mean of 19.5 ± 9.8% to a postoperative mean of 63.1 ± 6.1% (p < 0.001). The postoperative values were not statistically significantly different from the preoperative target points (p = 0.688). The mFTA was corrected to a postoperative mean of valgus 3.8 ± 1.4 degrees. The PTS angle showed no significant change (p = 0.256). A 3D printed model using CT may be useful for preoperative planning of open-wedge HTO. Satisfactory correction can be obtained without a change in the PTS.


Subject(s)
Osteoarthritis, Knee/surgery , Osteotomy/methods , Printing, Three-Dimensional , Tibia/surgery , Female , Humans , Male , Middle Aged , Postoperative Period , Radiography , Retrospective Studies , Tomography, X-Ray Computed , Weight-Bearing
6.
Knee Surg Sports Traumatol Arthrosc ; 26(11): 3452-3458, 2018 Nov.
Article in English | MEDLINE | ID: mdl-29602970

ABSTRACT

PURPOSE: The purpose of this study was to compare the accuracy of the preoperative planning method using a three-dimensional (3D) printed model with that of a method using picture archiving and communication system (PACS) images in high tibial osteotomy (HTO). METHODS: Patients who underwent HTO using a 3D printed model (20 patients) and a method based on PACS images (20 patients) from 2012 to 2016 were compared. After obtaining the correction angle, in the 3D printed method, the wedge-shaped 3D printed model was designed. The PACS method used preoperative radiographs. The accuracy of HTO for each method was compared using radiographs obtained at the first postoperative year. The preoperative and postoperative posterior tibial slope angles were also compared. RESULTS: The weight-bearing line was corrected 21.2 ± 11.8% from preoperatively to 61.6 ± 3.3% postoperatively in the 3D group and from 19.4 ± 12.3% to 61.3 ± 8.1% in the PACS group. The mean absolute difference with the target point was lower in the 3D group (2.3 ± 2.5) than in the PACS group (6.2 ± 5.1; p = 0.005). The number of patients in an acceptable range was higher in the 3D group than in the PACS group. The posterior tibial slope angle was not significantly different in the 3D group (8.6°-8.9°), but was significantly different in the PACS group (9.9°-10.5°, p = 0.042). CONCLUSIONS: In open-wedge HTO, a more accurate correction for successful results could be obtained using the 3D printed model. LEVEL OF EVIDENCE: IV.


Subject(s)
Models, Anatomic , Osteotomy/methods , Printing, Three-Dimensional , Tibia/surgery , Female , Humans , Image Processing, Computer-Assisted , Male , Middle Aged , Preoperative Period , Retrospective Studies , Tibia/diagnostic imaging , Tomography, X-Ray Computed
7.
Arch Orthop Trauma Surg ; 137(11): 1523-1528, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28821936

ABSTRACT

INTRODUCTION: Exchange nailing is most acceptable for treating hypertrophic non-union of the long bones, requiring the removal of previously fixed implant. However, its main effect of mechanical stabilization is controversial in non-isthmal area. We hypothesized that minimally invasive plate augmentation over the non-union site may have a better option, without the need of bone grafting or removing pre-existing implants. MATERIALS AND METHODS: Seventeen patients with hypertrophic non-union of the long bones between 2010 and 2014 on radiography who previously underwent intramedullary (IM) nailing or plate osteosynthesis for long-bone fractures were included. A locking compression plate was inserted with at least three mono- or bicortical screws at each proximal and distal segment. Broken or loosened interlocking screws of IM nail were simultaneously re-fixed. Fracture site exposure, pre-fixed implant removal, and bone grafting were not performed. We investigated whether union occurred and analyzed functional outcomes and complications. RESULTS: Eleven femoral and six tibial non-unions were prospectively included. In the pre-existing implants, 13 nails and 4 plates were found. All cases achieved union at a mean 22.7 weeks. One case of superficial infection was managed with oral antibiotics. Deep infection or implant failure did not occur. CONCLUSIONS: Minimally invasive plate augmentation can achieve additional stability and promote healing of hypertrophic non-union of the long bones. When indicated, this technique is the least invasive alternative to exchange nailing and reduces surgical risks in the treatment of diaphyseal non-union.


Subject(s)
Bone Plates , Femur/surgery , Minimally Invasive Surgical Procedures , Orthopedic Procedures , Tibia/surgery , Cohort Studies , Humans , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/methods , Orthopedic Procedures/adverse effects , Orthopedic Procedures/methods
8.
J Orthop Sci ; 22(5): 919-923, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28688811

ABSTRACT

BACKGROUND: Guided growth using the eight-plate (8-plate) is the most commonly used method to correct angular deformities in children; however, implant failure has been reported. Recently, the 3.5-mm reconstruction plate (R-plate) has been used as an alternative option for guided growth; however, hardware prominence has been problematic. This study aimed to compare the coronal angular deformity correction results of guided growth between relatively thin 8-plates with cannulated screws and thick R-plates with solid screws. METHODS: Thirty-nine physes (24 distal femoral, 15 proximal tibial) in 20 patients underwent hemiepiphysiodesis using 8-plates, and 61 physes (40 distal femoral, 21 proximal tibial) in 35 patients underwent hemiepiphysiodesis using R-plates. Coronal angular corrections were measured and compared preoperatively, and after the completion of corrections. Amounts and rates of correction and complications were compared between the groups. RESULTS: Mean body mass index was 18.7 kg/m2 in the 8-plate group, and 22.7 kg/m2 in the R-plate group. Angular correction was achieved in all deformities at a mean of 13.7 months and 19.7 months in the 8-plate and the R-plate group, respectively. The mean corrected mechanical lateral distal femoral angle was 9.0° in the 8-plate group, and 9.9° in the R-plate group (P = 0.55). The mean corrected medial proximal tibial angle was 7.1° in the 8-plate group, and 9.0° in the R-plate group (P = 0.07). The mean rates of angular correction were also not significantly different in the distal femur (1.03°/month vs. 0.77°/month, P = 0.2) and the proximal tibia (0.66°/month vs. 0.63°/month, P = 0.77). There was one superficial infection in each group, and one case of implant failure in the R-plate group. Two rebound deformities were observed and needed repeat hemiepiphysiodesis. Permanent physeal arrest was not observed in this series.


Subject(s)
Bone Plates , Joint Diseases/surgery , Knee Joint/abnormalities , Knee Joint/surgery , Adolescent , Bone Screws , Child , Child, Preschool , Female , Humans , Knee Joint/growth & development , Male , Orthopedic Procedures/instrumentation , Orthopedic Procedures/methods , Prosthesis Design , Retrospective Studies
9.
Int J Comput Assist Radiol Surg ; 12(5): 855-864, 2017 May.
Article in English | MEDLINE | ID: mdl-28063078

ABSTRACT

PURPOSE: Radiographic measurements using two-dimensional (2D) plain radiographs or planes from computed tomography (CT) scans have several drawbacks, while measurements using images of three-dimensional (3D) reconstructed bone models can provide more consistent anthropometric information. We compared the consistency of results using measurements based on images of 3D reconstructed bone models (3D measurements) with those using planes from CT scans (measurements using 2D slice images). METHODS: Ninety-six of 561 patients who had undergone deep vein thrombosis-CT between January 2013 and November 2014 were randomly selected. We evaluated measurements using 2D slice images and 3D measurements. The images used for 3D reconstruction of bone models were obtained and measured using [Formula: see text] and [Formula: see text] (Materialize, Leuven, Belgium). RESULTS: The mean acetabular inclination, acetabular anteversion and femoral anteversion values on 2D slice images were 42.01[Formula: see text], 18.64[Formula: see text] and 14.44[Formula: see text], respectively, while those using images of 3D reconstructed bone models were 52.80[Formula: see text], 14.98[Formula: see text] and 17.26[Formula: see text]. Intra-rater reliabilities for acetabular inclination, acetabular anteversion, and femoral anteversion on 2D slice images were 0.55, 0.81, and 0.85, respectively, while those for 3D measurements were 0.98, 0.99, and 0.98. Inter-rater reliabilities for acetabular inclination, acetabular anteversion and femoral anteversion on 2D slice images were 0.48, 0.86, and 0.84, respectively, while those for 3D measurements were 0.97, 0.99, and 0.97. CONCLUSION: The differences between the two measurements are explained by the use of different tools. However, more consistent measurements were possible using the images of 3D reconstructed bone models. Therefore, 3D measurement can be a good alternative to measurement using 2D slice images.


Subject(s)
Femur/diagnostic imaging , Imaging, Three-Dimensional/methods , Plastic Surgery Procedures/methods , Tomography, X-Ray Computed/methods , Acetabulum/surgery , Aged , Female , Femur/surgery , Humans , Male , Middle Aged , Orientation, Spatial , Radiography , Reference Values , Reproducibility of Results , Venous Thrombosis/diagnostic imaging
10.
Injury ; 48(3): 751-757, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28093251

ABSTRACT

INTRODUCTION: Although minimally invasive plate osteosynthesis (MIPO) is a preferred operative treatment for fractures of the distal femur, malalignment is a significant concern because of indirect reduction of the fracture. The purpose of this study, therefore, was to evaluate radiologic alignment after MIPO for distal femoral fractures. PATIENTS AND METHODS: Of the 138 patients with fracture of the distal femur who underwent MIPO, we enrolled 51 patients in whom bilateral rotational alignment could be assessed by postoperative computed tomography (CT). The patients included 32 men and 19 women, with a mean age of 54.3 years. Thirteen patients had femoral shaft fractures (according to the AO/OTA classification: 32-A, n=2; 32-B, n=6; 32-C, n=5), whereas 38 patients had distal femoral fractures (33-A, n=7; 33-C, n=31). Coronal and sagittal alignments were assessed using simple radiography, whereas rotational alignment was assessed using CT. According to the difference between the affected and unaffected sides, we divided the patients into satisfactory and unsatisfactory groups (reference point of 8°, using Handolin's classification). Thereafter, we determined which factors can lead to malalignment, including fracture location (distal femoral shaft fracture or metaphyseal fracture), fracture pattern (simple fracture, n=15; complex fractures, n=36 patients), coronal and sagittal alignments, and combined ipsilateral long bone fractures. RESULTS: Coronal and sagittal alignment were satisfactory in 96.2% (average, 2.8°) and 98% (average, 2.2°), respectively, whereas the rotational alignment was satisfactory in 56.9% of patients. Leg length discrepancy was satisfactory in 92.3% of the patients (average, 10.9mm). Concerning rotational malalignment, an unsatisfactory result was obtained in 48.6% of subjects with complex fractures and 26.7% of subjects with simple fractures (p=0.114). No significant correlation was noted between the angular deformity in the coronal and sagittal planes and the degree of rotational alignment (p=0.607 and 0.774, respectively). CONCLUSIONS: Regardless of the fracture pattern, rotational malalignment may occur at an extremely high rate after MIPO for fractures of the distal femur.


Subject(s)
Bone Malalignment/diagnostic imaging , Bone Plates/adverse effects , Femoral Fractures/surgery , Fracture Fixation, Internal/adverse effects , Minimally Invasive Surgical Procedures/adverse effects , Tomography, X-Ray Computed , Adolescent , Adult , Aged , Aged, 80 and over , Bone Malalignment/etiology , Bone Malalignment/physiopathology , Bone Screws/adverse effects , Female , Femoral Fractures/diagnostic imaging , Femoral Fractures/physiopathology , Fracture Fixation, Internal/methods , Fracture Healing , Humans , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Republic of Korea/epidemiology , Treatment Outcome , Young Adult
11.
Knee ; 24(1): 16-22, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27876267

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the usefulness of three-dimensional (3D) printed models for open wedge high tibial osteotomy (HTO) in porcine bone. METHODS: Computed tomography (CT) images were obtained from 10 porcine knees and 3D imaging was planned using the 3D-Slicer program. The osteotomy line was drawn from the three centimeters below the medial tibial plateau to the proximal end of the fibular head. Then the osteotomy gap was opened until the mechanical axis line was 62.5% from the medial border along the width of the tibial plateau, maintaining the posterior tibial slope angle. The wedge-shaped 3D-printed model was designed with the measured angle and osteotomy section and was produced by the 3D printer. The open wedge HTO surgery was reproduced in porcine bone using the 3D-printed model and the osteotomy site was fixed with a plate. Accuracy of osteotomy and posterior tibial slope was evaluated after the osteotomy. RESULTS: The mean mechanical axis line on the tibial plateau was 61.8±1.5% from the medial tibia. There was no statistically significant difference (P=0.160). The planned and post-osteotomy correction wedge angles were 11.5±3.2° and 11.4±3.3°, and the posterior tibial slope angle was 11.2±2.2° pre-osteotomy and 11.4±2.5° post-osteotomy. There were no significant differences (P=0.854 and P=0.429, respectively). CONCLUSION: This study showed that good results could be obtained in high tibial osteotomy by using 3D printed models of porcine legs.


Subject(s)
Osteotomy/methods , Printing, Three-Dimensional , Surgery, Computer-Assisted/methods , Tibia/diagnostic imaging , Tibia/surgery , Animals , Joint Prosthesis , Models, Anatomic , Models, Animal , Swine , Tomography, X-Ray Computed
12.
J Bone Metab ; 23(3): 135-42, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27622177

ABSTRACT

BACKGROUND: In 1951, Ardran reported that metastatic bone lesions could be detectable on plain radiography with 30% to 50% of decalcification. Authors performed experimental study for minimum level of decalcification to detect the osteolytic bone metastasis of long bone with recent technique of radiographs. METHODS: One pair of fibula and humerus from two cadavers was cut into specimen 1 inch in length. Distal half of specimen was dipped into hydrochloride (HCl) with 15 min interval. All 16 specimens were checked by film-type radiography (FR), computed radiography (CR), digital radiography (DR). To exclude inter-observer's variance, 3 radiologists evaluated images. Calcium amount before and after decalcification was measured and expressed in percentage of decalcification. RESULTS: Osteolytic changes were detectable with 11% to 16% of decalcification for fibula and 3% to 8% for humerus on plain radiography with FR, CR, and DR. CONCLUSIONS: Our study showed that minimum of 3% and maximum of 16% of decalcification is necessary when osteolytic metastatic bone lesions of long bone could be detected on plain radiography.

13.
J Bone Metab ; 23(2): 85-93, 2016 May.
Article in English | MEDLINE | ID: mdl-27294080

ABSTRACT

BACKGROUND: To retrospectively assess whether the response of subtrochanteric lateral cortex (STLC) is different according to the bisphosphonate agents in terms of bone mineral density (BMD) change. METHODS: A total of 149 subjects, who had 2- to 4-year interval follow-up of BMD using dual energy X-ray absorptiometry (DXA), were included in this retrospective study divided into following 3 groups: control group (no consumption of any anti-osteoporotic drugs, n=38), alendronate group (naïve alendronate users, n=48), risedronate group (naïve risedronate users, n=63). BMD was measured at the STLC and subtrochanteric medial cortex (STMC) in each patient by drawing rectangular ROIs at the bone cortices. The percent change of BMD at the STLC were compared between the aforementioned 3 groups by using analysis of covariance model to control five independent variables of age, body mass index, percent change of STMC, hip axis length, time interval between DXA examinations. RESULTS: The least square mean values±standard deviation of the percent change of BMD in the control, alendronate, and risedronate groups were 1.46±1.50, 2.23±1.26, and 6.96±1.11, respectively. The risedronate group showed significantly higher change of BMD percentage compared with the control (adjusted P=0.012) or alendronate (adjusted P=0.016) groups. CONCLUSIONS: The percent change of BMD at the STLC in the risedronate user group was greater than the alendronate and control groups. The implication of these changes needs to be further verified.

14.
Yonsei Med J ; 57(4): 905-14, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27189284

ABSTRACT

PURPOSE: The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. MATERIALS AND METHODS: Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. RESULTS: Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. CONCLUSION: Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women.


Subject(s)
Asian People , Bone Density Conservation Agents/therapeutic use , Denosumab/therapeutic use , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/ethnology , Aged , Aged, 80 and over , Bone Density , Double-Blind Method , Female , Femur , Femur Neck , Humans , Lumbar Vertebrae , Middle Aged , Postmenopause , Republic of Korea
15.
Yonsei Med J ; 57(4): 923-7, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27189286

ABSTRACT

PURPOSE: Up to 71% of South Korean postmenopausal women have vitamin D deficiency {serum 25-hydroxyvitamin D [25(OH) D] level <50 nmol/L}. Data on vitamin D supplementation was collected during the screening phase of an efficacy/safety study of denosumab in Korean postmenopausal women with osteoporosis. This report describes the effect of vitamin D supplementation on repletion to 25(OH)D levels ≥50 nmol/L in Korean postmenopausal women with osteoporosis. MATERIALS AND METHODS: Vitamin D levels of Korean postmenopausal women (60-90 years old) were measured by extracting 25(OH)D2 and 25(OH)D3 from serum samples via protein precipitation and using liquid chromatography with tandem mass spectrometry detection. Calibration curves were constructed from the mass chromatograms to obtain total vitamin D levels. Subjects with serum 25(OH)D levels <50 nmol/L were supplemented with 1000 IU of vitamin D tablets during the 2.5-month-long screening period. Dose, frequency, and duration were determined by the investigator. If repletion was achieved (≥50 nmol/L) on retest, subjects were eligible to be rescreened for study entry. RESULTS: Of 371 subjects screened, 191 (52%) required vitamin D supplementation, and 88% (168 of 191) were successfully repleted. More than half of the subjects (58%) who were successfully repleted received doses of 2000 IU daily. The mean time to successful repletion was 31 days (standard deviation 8.4 days; range 11-48 days). CONCLUSION: Supplementation with daily median doses of 2000 IU vitamin D successfully repleted 88% of Korean postmenopausal women with osteoporosis within 48 days to a serum vitamin D level of 50 nmol/L.


Subject(s)
Asian People , Bone Density Conservation Agents/therapeutic use , Dietary Supplements , Osteoporosis, Postmenopausal/complications , Vitamin D Deficiency/drug therapy , Vitamin D/therapeutic use , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Middle Aged , Osteoporosis, Postmenopausal/drug therapy , Osteoporosis, Postmenopausal/ethnology , Postmenopause/blood , Republic of Korea , Vitamin D/analogs & derivatives , Vitamin D/blood , Vitamin D Deficiency/diagnosis , Vitamin D Deficiency/ethnology
16.
Injury ; 47(4): 832-6, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26606988

ABSTRACT

INTRODUCTION: Although tibia shaft fractures in children usually have satisfactory results after closed reduction and casting, there are several surgical indications, including associated fractures and soft tissue injuries such as open fractures. Titanium elastic nails (TENs) are often used for pediatric tibia fractures, and have the advantage of preserving the open physis. However, complications such as delayed union or nonunion are not uncommon in older children or open fractures. In the present study, we evaluated children up to 10 years of age with closed or open tibial shaft fractures treated with elastic nailing technique. METHODS: A total of 16 tibia shaft fractures treated by elastic nailing from 2001 to 2013 were reviewed. The mean patient age at operation was 7 years (range: 5-10 years). Thirteen of 16 cases were open fractures (grade I: 4, grade II: 6, grade IIIA: 3 cases); the other cases had associated fractures that necessitated operative treatments. Closed, antegrade intramedullary nailing was used to insert two nails through the proximal tibial metaphysis. All patients were followed up for at least one year after the injury. Outcomes were evaluated using modified Flynn's criteria, including union, alignment, leg length discrepancies, and complications. RESULTS: All fractures achieved union a mean of 16.1 weeks after surgery (range: 11-26 weeks). No patient reported knee pain or experienced any loss of knee or ankle motion. There was a case of superficial infection in a patient with grade III open fracture. Three patients reported soft tissue discomfort due to prominent TEN tips at the proximal insertion site, which required cutting the tip before union or removing the nail after union. At the last follow-up, there were no angular or rotational deformities over 10° in either the sagittal or coronal planes. With the exception of one case with an overgrowth of 15 mm, no patient showed shortening or overgrowth exceeding 10mm. Among final outcomes, 15 were excellent and 1 was satisfactory. SUMMARY: Even with open fractures or soft tissue injuries, elastic nailing can achieve satisfactory results in young children, with minimal complications of delayed bone healing, or infection.


Subject(s)
Bone Nails , Fracture Fixation, Intramedullary , Fractures, Open/surgery , Soft Tissue Injuries/surgery , Tibial Fractures/surgery , Child , Female , Follow-Up Studies , Fracture Fixation, Intramedullary/instrumentation , Fracture Fixation, Intramedullary/methods , Fracture Healing , Fractures, Open/physiopathology , Humans , Male , Retrospective Studies , Tibial Fractures/physiopathology , Treatment Outcome
17.
Proc Inst Mech Eng H ; 229(10): 693-702, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26297136

ABSTRACT

Epiduroscopic laser neural decompression is an emerging therapeutic modality to treat lumbar spine pathologies including chronic low back pain, spinal stenosis, and disk herniation via catheter insertion followed by laser ablation of the lesion. Despite the efficacy of epiduroscopic laser neural decompression, excessive radiation doses due to fluoroscopy during epiduroscopic laser neural decompression have limited its widespread application. To address the issue, we propose a surgical navigation system to assist in epiduroscopic laser neural decompression procedures using radiation-free image guidance. An electromagnetic tracking system was used as the basic modality to track the internal location of the surgical instrument with respect to the patient body. Patient-to-image registration was carried out using the point-based registration method to determine the transformation between the coordinate system of the patient and that of the medical images. We applied the proposed system in epiduroscopic laser neural decompression procedures to assess its effectiveness, and the outcomes confirmed its clinical feasibility. To the best of our knowledge, this is a report on the first surgical navigation applied for epiduroscopic laser neural decompression procedure.


Subject(s)
Decompression, Surgical/methods , Epidural Space/surgery , Laser Therapy/methods , Surgery, Computer-Assisted/methods , Epidural Space/diagnostic imaging , Fluoroscopy , Humans
18.
J Bone Metab ; 21(3): 205-12, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25247158

ABSTRACT

INTRODUCTION: Bone mineral density (BMD) is an important index in diagnosis of osteoporosis and other metabolic bone diseases, prediction of fractures, and monitoring treatment. This study was to find a more feasible technique for prediction of osteoporotic fracture between dual energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT) and to reveal the actual change of bone strength when BMD was changed. METHODS: Ten of these 20 specimens were used as the demineralized group and the other 10 as the control. Each specimen was immersed in HCl solution at for a period of at least 10 minutes, up to 100 minutes, at an interval of 10 minutes for different levels of demineralization. BMD was measured using DXA and QCT. Uniaxial compression tests were conducted to measure biomechanical parameters. Pearson correlation analysis was used respectively between BMD and biomechanical parameters and between DXA and QCT. RESULTS: Elastic modulus (r=0.87) and yield stress (r=0.84) showed a statistically significant correlation with DXA BMD. Through correlation analysis with QCT BMD and elastic modulus, correlation coefficient showed hemi-vertebra (r=0.80) and trabecular (r=0.68). In yield stress, there was a statistically significant correlation in hemi-vertebra (r=0.87) and trabecular bone (r=0.84). CONCLUSION: DXA is a current standard technique not only for diagnosis of osteoporosis but also for prediction of fracture risk compared to QCT. Actual decrease of bone strength was much greater than that of BMD by both DXA and QCT.

19.
Article in English | MEDLINE | ID: mdl-25571575

ABSTRACT

In femoral fracture reduction, orthopedic surgeons must pull distal bone fragments with great traction force and return them to their correct positions, by referring to 2D-fluoroscopic images. Since this method is physically burdensome, the introduction of robotic assistance is desirable. While such robots have been developed, adequate control methods have not yet been established because of the lack of experimental data. It is difficult to obtain accurate data using cadavers or animals because they are different from the living human body's muscle characteristics and anatomy. Therefore, an experimental model for simulating human femoral characteristics is required. In this research, human muscles are reproduced using a McKibben-type pneumatic rubber actuator (artificial muscle) to develop a model that simulates typical femur muscles using artificial muscles.


Subject(s)
Artificial Organs , Femoral Fractures/pathology , Models, Biological , Animals , Femoral Fractures/therapy , Femur/anatomy & histology , Fluoroscopy , Humans , Muscle Contraction , Robotics
20.
BMC Womens Health ; 13: 7, 2013 Feb 14.
Article in English | MEDLINE | ID: mdl-23410131

ABSTRACT

BACKGROUND: A vast amount of literature describes the incidence of fracture as a risk for recurrent osteoporotic fractures in western and Asian countries. Osteoporosis evaluation and treatment after a low-trauma fracture, however, has not been well characterized in postmenopausal women in Asia. The purpose of this study was to characterize patient and health system characteristics associated with the diagnosis and management of osteoporosis among postmenopausal women hospitalized with a fragility fracture in Asia. METHODS: Patient surveys and medical charts of postmenopausal women (N=1,122) discharged after a fragility hip fracture from treatment centers in mainland China, Hong Kong, Singapore, South Korea, Malaysia, Taiwan, and Thailand between July 1, 2006 and June 30, 2007 were reviewed for bone mineral density (BMD) measurement, osteoporosis diagnosis, and osteoporosis treatment. RESULTS: The mean (SD) age was 72.9 (11.5) years. A BMD measurement was reported by 28.2% of patients, 51.5% were informed that they had osteoporosis, and 33.0% received prescription medications for osteoporosis in the 6 months after discharge. Using multivariate logistic regression analyses, prior history of fracture decreased the odds of a BMD measurement (OR 0.63, 95% CI 0.45-0.88). Having a BMD measurement increased the odds of osteoporosis diagnosis (OR 10.1, 95% CI 6.36-16.0), as did having health insurance (OR 4.95, 95% CI 1.51-16.21 for private insurance with partial self-payment relative to 100% self-payment). A history of fracture was not independently associated with an osteoporosis diagnosis (OR 0.80, 95% CI 0.56-1.15). Younger age reduced the odds of receiving medication for osteoporosis (OR 0.59, 95% CI 0.36-0.96 relative to age ≥65), while having a BMD measurement increased the odds (OR 1.79, 95% CI 1.23-2.61). CONCLUSIONS: Osteoporosis diagnosis and treatment in Asian countries were driven by BMD measurement but not by fracture history. Future efforts should emphasize education of general practitioners and patients about the importance of fracture.


Subject(s)
Osteoporosis, Postmenopausal/diagnostic imaging , Osteoporosis, Postmenopausal/epidemiology , Osteoporotic Fractures/diagnostic imaging , Osteoporotic Fractures/epidemiology , Postmenopause , Adult , Bone Density , China/epidemiology , Comorbidity , Female , Hong Kong/epidemiology , Humans , Logistic Models , Malaysia/epidemiology , Middle Aged , Odds Ratio , Osteoporosis, Postmenopausal/therapy , Osteoporotic Fractures/therapy , Radiography , Republic of Korea/epidemiology , Retrospective Studies , Risk Factors , Singapore/epidemiology , Taiwan/epidemiology , Thailand/epidemiology , Women's Health/statistics & numerical data
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