Phase III clinical trial of autologous CD34 + cell transplantation to accelerate fracture nonunion repair.

BACKGROUND: We previously demonstrated that CD34 + cell transplantation in animals healed intractable fractures via osteogenesis and vasculogenesis; we also demonstrated the safety and efficacy of this cell therapy in an earlier phase I/II clinical trial conducted on seven patients with fracture nonunion. Herein, we present the results of a phase III clinical trial conducted to confirm the results of the previous phase studies using a larger cohort of patients. METHODS: CD34 + cells were mobilized via administration of granulocyte colony-stimulating factor, harvested using leukapheresis, and isolated using magnetic cell sorting. Autologous CD34 + cells were transplanted in 15 patients with tibia nonunion and 10 patients with femur nonunion, who were followed up for 52 weeks post transplantation. The main outcome was a reduction in time to heal the tibia in nonunion patients compared with that in historical control patients. We calculated the required number of patients as 15 based on the results of the phase I/II study. An independent data monitoring committee performed the radiographic assessments. Adverse events and medical device failures were recorded. RESULTS: All fractures healed during the study period. The time to radiological fracture healing was 2.8 times shorter in patients with CD34 + cell transplantation than in the historical control group (hazard ratio: 2.81 and 95% confidence interval 1.16-6.85); moreover, no safety concerns were observed. CONCLUSIONS: Our findings strongly suggest that autologous CD34 + cell transplantation is a novel treatment option for fracture nonunion. TRIAL REGISTRATION: UMIN-CTR, UMIN000022814. Registered on 22 June 2016.

Development and Analysis of Mouse Medial Meniscus Posterior Root Tear Model.

Medial meniscus posterior root tears (MMPRT) are often associated with osteoarthritis (OA) progression and subchondral bone insufficiency fractures. This study aimed to develop the first MMPRT mouse model. The MMPRT model was created by sectioning the medial meniscus posterior root of 12-week-old CL57BL/6J male mice under stereomicroscopic observation. The sham operation and the destabilization of the medial meniscus (DMM) model groups were also created. OA progression and subchondral bone changes were evaluated histologically using the Osteoarthritis Research Society International (OARSI) subchondral bone scoring system at 2, 4, 8, and 12 weeks after surgery. Microcomputed tomography (µCT) was performed to evaluate the presence of insufficient fractures. OA progression and medial meniscus extrusion were observed in the MMPRT and DMM models 12 weeks after surgery. OA progressed in both models during the time course, without a significant difference in the OARSI score between the two groups. The subchondral bone score was significantly higher at 12 weeks than at 2 and 4 weeks in the MMPRT group, while no significant difference was found between the two groups. In the µCT analysis, destruction of the medial tibial plateau was observed in 4/40 knees, while none were observed in the DMM group. Of the four knees, destruction of the medial femoral condyle was also observed in three knees. Characteristic pathological changes were observed in the mouse MMPRT model. The mouse MMPRT model may be useful for investigating pathological changes after MMPRT.

Prosthetic orientation, limb alignment, and soft tissue balance with bi-cruciate stabilized total knee arthroplasty: a comparison between the handheld robot and conventional techniques.

PURPOSE: This study aimed to examine the prosthetic orientations, limb alignment, intraoperative soft tissue balance, and early clinical outcomes associated with the use of the relatively new handheld robot technique compared to those associated with the use of the conventional alignment guide for bi-cruciate stabilized total knee arthroplasty (TKA). METHODS: This retrospective cohort study compared the prosthetic orientation and limb alignment of 35 patients who underwent TKA using robotic assistance (robot group) with those of patients who underwent TKA using a conventional alignment guide (control group). The coronal femoral component alignment (FCA), coronal tibial component alignment (TCA), and the hip-knee-ankle (HKA) angle were compared between groups. Intraoperative soft tissue balance, including the joint component gap and varus/valgus balance assessed by an offset-type tensor, were also compared between groups. One year postoperatively, the clinical outcomes, including the range of motion and 2011 Knee Society Score (KSS), were compared between groups. RESULTS: The HKA angle and FCA were 0.1° varus and 0.1° varus, respectively, in the robot group and 1.3° varus and 1.3° varus, respectively, in the control group. The difference in the HKA angle and the FCA, but not the TCA, between groups was statistically significant (p < 0.05). The intraoperative soft tissue balance showed more stable joint component gaps and varus/valgus balances throughout the range of motion in the robot group than in the control group. Clinical outcomes of the robot group showed superior 2011 KSS subscales compared to those of the control group. CONCLUSION: The accuracy of the implantations and stable soft tissue balance in the robot group were superior to those of the control group. The robot group also had superior patient-reported scores for early clinical outcomes.

Risk factors of residual pivot-shift after anatomic double-bundle anterior cruciate ligament reconstruction.

INTRODUCTION: Although anterior cruciate ligament reconstruction (ACLR) is considered a successful procedure, residual pivot-shift after surgery remains to be solved. The purpose of this study was to comprehensively evaluate the risk factors of residual pivot-shift after anatomic double-bundle (DB) ACLR. MATERIALS AND METHODS: A total of 164 patients who underwent primary anatomic DB-ACLR between January 2014 and December 2019 and screw removal after the index ACLR in our hospital were included in this retrospective case-control study. The manual pivot-shift test was performed under general anesthesia during screw removal surgery, and patients with grade 1 or higher pivot-shift were classified as the positive pivot-shift group, and those with grade 0 were defined as the negative pivot-shift group. Univariate and logistic regression analyses were performed to identify the factors associated with postoperative residual pivot-shift. Assessment included sex, age, time to surgery, preoperative Tegner activity scale, preoperative pivot-shift grade, preoperative anterior tibial translation by the KT-2000 arthrometer measurement, meniscus injury and its surgical procedure, knee hyperextension, cartilage damage, Segond fracture, medial and lateral posterior tibial slope, lateral-medial slope asymmetry, participation in pivoting sport/activity at the time of injury, and return to sports at postoperative one year line. RESULTS: Postoperative positive pivot-shift was observed in 14 (8.5%) of 164 patients. The KT-2000 measurement at 1-year postoperatively was significantly higher in the residual pivot-shift-positive group than in the negative group (P < 0.05). Logistic regression analysis revealed that age of patients < 20 years [P < 0.05, odds ratio (OR): 6.1)], preoperative pivot-shift grade (P < 0.05, OR: 4.4), and hyperextended knee (P < 0.05, OR: 11.8) were risk factors of postoperative pivot-shift. There were no statistically significant differences between other variables. CONCLUSIONS: Patients < 20 years of age, with high-grade preoperative pivot-shift, or hyperextended knees had a higher risk of residual postoperative pivot-shift.

Human Non-Hypertrophic Nonunion Tissue Contains Osteoblast Lineage Cells and E-BMP-2 Activates Osteogenic and Chondrogenic Differentiation.

In this study, we examined the proliferation capability and osteogenic and chondrogenic differentiation potential of non-hypertrophic nonunion cells (NHNCs), and the effect of Escherichia coli-derived BMP-2 (E-BMP-2) on them. We enrolled five patients with non-hypertrophic nonunion. NHNCs isolated from nonunion tissue sampled during surgery were cultured, passaged, counted every 14 days, and analyzed. NHNCs were homogenous fibroblastic adherent cells and long-lived through at least 10 passages, with a slight decline. The cells were consistently positive for mesenchymal stem cell-related markers CD73 and CD105, and negative for the hematopoietic markers CD14 and CD45. NHNCs could differentiate into osteoblast lineage cells; however, they did not have strong calcification or sufficient chondrogenic differentiation capability. E-BMP-2 did not affect the proliferative capability of the cells but improved their osteogenic differentiation capability by increasing alkaline phosphatase activity and upregulating the gene expression of osterix, bone sialoprotein, and osteocalcin. E-BMP-2 enhanced their chondrogenic differentiation capability by upregulating the gene expression of aggrecan and collagen type II. We showed, for the first time, that NHNCs have the capacity to differentiate into osteoblast-lineage cells, although the chondrogenic differentiation potential was poor. Local application of E-BMP-2 with preservation of nonunion tissue is a potential treatment option for non-hypertrophic nonunion.

Antioxidant effect of nicotinamide mononucleotide in tendinopathy.

BACKGROUND: A link between tendinopathy and oxidative stress has been recently reported. Nicotinamide mononucleotide (NMN) is a precursor of nicotinamide adenine dinucleotide, which plays an important role in cell redox homeostasis. The aim of this study was to evaluate the antioxidant effect of NMN on tendinopathy in vitro and in vivo. METHODS: Tenocytes from healthy Sprague-Dawley rats were cultured in regular glucose (RG) and high-glucose (HG) conditions with or without NMN, and were divided into four groups: RG NMN(-), RG NMN(+), HG NMN(-), and HG NMN(+). Cell viability, reactive oxygen species (ROS) accumulation, apoptotic rate, and mRNA expression of nicotinamide adenine dinucleotide phosphate oxidase (NOX)1, NOX4, interleukin (IL)6, sirtuin (SIRT)1, and SIRT6 were investigated. In addition, rats with collagenase-induced tendinopathy were treated with or without NMN. Immunostaining of NOX1 and NOX4; mRNA expression of SIRT1, SIRT6, and IL6; and superoxide dismutase (SOD) activity measurements in the Achilles tendon were performed. RESULTS: NMN increased the expression of SIRT1 and SIRT6 in rat tenocytes, but decreased the levels of NOX1, NOX4, IL6, ROS, and apoptosis. In Achilles tendons with collagenase-induced tendinopathy, NMN increased the mRNA expression of SIRT1 and SIRT6, as well as SOD activity; while suppressing protein expression of NOX1 and NOX4, and mRNA expression of IL6. CONCLUSION: The in vitro and in vivo results of this study show that NMN exerts an antioxidant effect on tendinopathy by promoting the expression of SIRT while inhibiting that of NOX.

Effectiveness of an accelerometer-based portable navigation for intraoperative adjustment of leg length discrepancy in total hip arthroplasty in the supine position.

BACKGROUND: This study aimed to examine the accuracy of the HipAlign® accelerometer-based portable navigation system by measuring the intraoperative leg length change of patients who underwent total hip arthroplasty (THA) and comparing the measured leg length discrepancy (LLD) determined by the navigation system and a freehand technique. METHODS: A total of 61 patients who underwent THA using the anterolateral approach in the supine position were included in this study and divided into two groups: those who underwent THA with navigation (Group N; N = 31) and with the freehand technique (Group F; N = 30). Statistical analyses were performed to compare the intraoperative leg length change, pre- and post-LLD, absolute values of post-LLD, and the number of patients with the postoperative LLD within 10 mm and 5 mm between the two groups. Additionally, we examined the correlation between the leg length change obtained through intraoperative navigation and measured from the radiographs. Moreover, to evaluate the navigation accuracy, we examined the correlation between the absolute error of leg length change and cup orientation. RESULTS: The postoperative LLD was significantly lower and the number of patients with the postoperative LLD within 5 mm was significantly higher in Group N, compared with Group F. Additionally, the amount of leg length change measured intraoperatively by the navigation system was strongly correlated with the values obtained by the postoperative radiographic measurement with a small absolute error and minimal wasted time. Moreover, a significant positive correlation was found between the absolute error of the leg length change and that of the cup inclination. CONCLUSIONS: Our study demonstrates that the accelerometer-based portable navigation system is useful for the intraoperative adjustment of leg length discrepancy during THA for patients in the supine position, as it provides good accuracy and minimizes required time for use.

The severity of preoperative varus deformity affects the feasibility of correcting lower limb alignment with medial unicompartmental knee arthroplasty.

BACKGROUND: The relationship between the severity of preoperative varus deformity and the amount of its correction in unicompartmental knee arthroplasty (UKA) as well as the thickness of the insert has not been well known. METHODS: One hundred and three patients who underwent medial fixed-bearing UKA with the use of the spacer block method were assessed. After the component gap in extension was measured using a UKA tensor, the pre-osteotomy gap was calculated from the thickness of the bone cuts. The relationship between the preoperative hip-knee-ankle (HKA) angle as well as the pre-osteotomy gap and the amount of change in HKA angle were analysed. Also, preoperative HKA angle and the thickness of the bone cuts were compared among groups by the insert thickness. RESULTS: The mean preoperative HKA angle was 7.7 ± 3.1° varus. Patients with more varus deformity and those with a wider pre-osteotomy gap showed a more valgus change in HKA angle. As for the thickness of the insert, the preoperative HKA angle of the patients with the thinnest insert was significantly smaller (less varus) than that of those with the thicker insert while no statistically significant difference was found among the insert groups regarding the amount of the bone cuts. CONCLUSIONS: The severity of the preoperative varus deformity as well as the intraoperative pre-osteotomy gap related to the amount of change in HKA angle. As thick inserts tended to be used in severe varus knees, the tibial bone cut can be reduced in such cases.

Hydroxyapatite-coated compaction short stem represents a characteristic pattern of peri-prosthetic bone remodelling after total hip arthroplasty.

PURPOSE: We aimed to investigate the differences in peri-prosthetic bone remodelling between the full hydroxyapatite (HA)-collared compaction short stem and the short tapered-wedge stem. METHODS: This retrospective cohort study enrolled 159 consecutive patients (159 joints) undergoing total hip arthroplasty (THA) using the full HA compaction short (n = 64) and short tapered-wedge (n = 95) stems. Body mass index (BMI), peri-prosthetic bone mineral density (BMD), and clinical factors, including the Japanese Orthopaedic Association score and the University of California Los Angeles (UCLA) activity score were assessed and compared. RESULTS: Stem related complications were seen in three cases. Both groups showed similar peri-prosthetic BMD changes. Peri-prosthetic BMD was almost maintained in the distal femur and Gruen zone 6 with both type of stems, but significant BMD loss was found in zones 1 and 7 in both groups and in zone 2 of the full HA compaction stem group. No significant correlations were found between the proximal femoral BMD changes and the age, BMI, and UCLA score in both the full HA compaction and tapered-wedge stem groups. Femoral bone shape affected the peri-prosthetic BMD changes in the tapered-wedge stem group but not in the full HA compaction group. The stem collar of the full HA compaction stem did not affect peri-prosthetic BMD, but unique bone remodelling in the calcar region was observed in 27.6% cases. A significant difference in the peri-prosthetic BMD changes at Gruen zone 2 was found in patients with or without thigh pain. CONCLUSION: Peri-prosthetic bone remodelling remained unaffected by clinical and radiographic factors after THA with the new short full HA compaction stem. Therefore, this new stem may be useful in a variety of cases.

Preoperative uncorrectable tibiofemoral subluxation can worsen clinical outcomes after fixed-bearing unicompartmental knee arthroplasty: a retrospective analysis.

INTRODUCTION: The presence of tibiofemoral subluxation (TFS) in patients with unicompartmental arthritis, a potential contraindication to unicompartmental knee arthroplasty (UKA), remains controversial and is not commonly discussed. This study aimed to determine the predictability of postoperative TFS before surgery and the effect of TFS on clinical outcomes after fixed-bearing UKA. MATERIALS AND METHODS: In total, 70 patients with anteromedial osteoarthritis and osteonecrosis of the knee who underwent fixed-bearing UKA from January 2015 to January 2017 were included. The preoperative TFS was assessed using plain anteroposterior and valgus stress radiographs. The patients were classified into three groups as follows: group A (acceptable TFS, n = 36) comprising patients with preoperative TFS less than 5.0 mm; group C (correctable TFS, n = 17) comprising patients with preoperative TFS of more than 5.0 mm but corrected to less than 5.0 mm under valgus stress; and group U (uncorrectable TFS, n = 17) comprising patients with preoperative TFS of more than 5.0 mm under valgus stress. Patient-derived clinical scores were assessed with the 2011 Knee Society Score preoperatively and 2 years postoperatively. The results were compared among the three groups using analysis of variance. RESULTS: Group U showed significantly higher postoperative TFS than groups A and C. Improvements in "symptoms" and "patient satisfaction" scores 2 years after surgery were significantly higher in groups A and C than in group U. CONCLUSION: Preoperative assessment of TFS under valgus stress could be a predictor of postoperative TFS. Furthermore, preoperative uncorrectable TFS could increase pain and decrease patient satisfaction 2 years after undergoing fixed-bearing UKA.

Utilization of Mechanical Stress to Treat Osteoporosis: The Effects of Electrical Stimulation, Radial Extracorporeal Shock Wave, and Ultrasound on Experimental Osteoporosis in Ovariectomized Rats.

Current treatment options for osteoporosis primarily involve pharmacotherapies, but they are often accompanied by undesirable side effects. Utilization of mechanical stress which can noninvasively induce bone formation has been suggested as an alternative to conventional treatments. Here, we examined the efficacy of mechanical stress induced by electrical stimulation, radial extracorporeal shock waves, and ultrasound for estrogen-deficient osteoporosis. Female Wistar rats were divided into following five groups: sham-operated group, untreated after ovariectomy, and treated with electrical stimulation, radial extracorporeal shock wave, or ultrasound starting at 8 weeks after ovariectomy for 4 weeks. Trabecular bone architecture of the femur was assessed by micro-CT and its biomechanical properties were obtained by mechanical testing. The femurs were further evaluated by histochemical, immunohistochemical, and real-time PCR analyses. Radial extracorporeal shock wave and ultrasound treatment improved trabecular bone microarchitecture and bone strength in osteoporotic rats, but not electrical stimulation. The shock wave decreased osteoclast activity and RANKL expression. The exposure of ultrasound increased osteoblast activity and ß-catenin-positive cells, and they decreased sclerostin-positive osteocytes. These findings suggest that mechanical stress induced by radial extracorporeal shock wave and ultrasound can improve estrogen-deficient bone loss and bone fragility through promoted bone formation or attenuated bone resorption.

Obesity is associated with less favorable outcomes following hip arthroscopic surgery: a systematic review and meta-analysis.

PURPOSE: The aim of this study was to systematically review the existing literature comparing the postoperative outcomes after following hip arthroscopy in obese and non-obese patients. METHODS: Studies comparing the outcomes following hip arthroscopy of obese and non-obese patients were systematically identified via a computer-assisted literature search of Pubmed (Medline), EMBASE, and Cochrane Library using the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Studies comparing the outcome of hip arthroscopy in different body mass index (BMI) groups were included. Data including patient-reported outcome measures (PROMs), revision arthroscopy rate, conversion rate to total hip arthroplasty (THA), and complications were collected. The methodological index for non-randomized studies (MINORS) and Newcastle-Ottawa Scale (NOS) were used to assess the quality of each study quality. The effect of heterogeneity was quantified by calculating the I2 value. RESULTS: A total of eight studies were finally included in the qualitative analysis, and three studies of high quality involving 373 hips were included in the quantitative assessment. All the studies defined obesity as a BMI of ≥ 30 kg/m2. The modified Harris Hip Score and the Non-Arthritic Hip Score were 5.1 (95% CI 1.1-9.1) and 9.0 (95% CI 5.0-13.1) points lower, respectively, in the obese group than in the non-obese group. The pooled odds ratios were 1.2 (95% CI 0.5-2.7) for revision arthroscopy, 2.4 (95% CI 1.3-4.6) for conversion to THA, and 3.2 (95% CI 1.2-8.6 for complications in favor of the non-obese group. The heterogeneity was low in all outcome assessments (I2 0-18%). CONCLUSION: Obese patients had significantly lower PROMs than non-obese patients following hip arthroscopic surgery, and the THA conversion and complication rates were 2.4 times and 3.2 times higher, respectively. Understanding the effect of obesity on hip arthroscopy will allow appropriate surgical indications for surgery to be further refined and help obese patients to understand their individual risk profile. LEVEL OF EVIDENCE: Systematic review of Level III-IV studies, Level IV.

The sagittal cutting plane affects evaluation of the femoral bone tunnel position on three-dimensional computed tomography after anterior cruciate ligament reconstruction.

PURPOSE: To investigate how the femoral sagittal cutting plane affects evaluation of the bone tunnel position after anterior cruciate ligament (ACL) reconstruction using the quadrant method in three-dimensional computed tomography (CT) imaging. METHODS: Thirty patients who underwent primary anatomic double-bundle ACL reconstruction and CT 2 weeks after surgery were enrolled. Three sagittal cutting planes with respect to the condylar axis were created using the CT images: at the top of the intercondylar notch (C-plane), 5% medial (M-plane), and 5% lateral (L-plane). The center of the bone tunnel position regarding depth and height of the anteromedial (AMB) and posterolateral bundle (PLB) were quantitatively evaluated using the quadrant method on the three different planes. RESULTS: The mean depths of AMB and PLB were 27.4 ± 4.4% and 39.7 ± 5.1%, 27.0 ± 4.2% and 37.6 ± 4.9%, and 27.4 ± 4.5% and 38.5 ± 6.0%, at the M, C and L planes, respectively. The mean heights of AMB and PLB were 30.8 ± 6.3% and 56.2 ± 5.6%, 30.4 ± 6.2% and 56.6 ± 5.6%, and 25.4 ± 7.0% and 52.9 ± 6.9% at the M, C, and L planes, respectively. Both AMB and PLB bone tunnels were evaluated as higher positions in the L-plane than the C-plane (p < 0.01, p = 0.02, respectively) and M-plane (p < 0.01, p = 0.04, respectively), but there were no significant differences between the C-plane and M-plane (n.s.). There was no significant difference in the anteroposterior direction for all planes. CONCLUSION: In evaluations of the bone tunnel position with the quadrant method using three-dimensional CT, the bone tunnel position depends on the femoral sagittal cutting plane. A consistent evaluation method should be used when evaluating the bone tunnel position after ACL reconstruction to enable correct evaluation clinically. LEVEL OF EVIDENCE: Case-control study, Level III.

Relationship between glenohumeral internal rotation deficit and shoulder conditions in professional baseball pitchers.

BACKGROUND: Previous studies have reported that glenohumeral internal rotation deficit (GIRD) may increase the risk of throwing-shoulder injuries. The purpose of this study was to analyze the conditions of the throwing shoulder in professional baseball pitchers with GIRD by comparing with those in pitchers without GIRD. METHODS: In total, 26 male professional baseball pitchers participated in this study. We evaluated passive range of motion (ROM) and isometric muscle strength at internal rotation (IR) and external rotation (ER) at 90° of abduction, as well as the muscle thickness of the supraspinatus (SSP) and infraspinatus (ISP) by ultrasound. The pitchers were divided into 2 groups: those who exhibited a loss of IR of ≥20° in the throwing shoulder (GIRD group) and those who did not (non-GIRD group). RESULTS: In the GIRD group, the total ROM deficit (throwing side - non-throwing side) (P < .001), the muscle thickness ratio (throwing to non-throwing) of the SSP and ISP (P = .017 and P = .014, respectively), and the muscle strength ratio (throwing to non-throwing) of ER (P = .028) were significantly lower than those in the non-GIRD group. In contrast, the muscle strength ratio (throwing to non-throwing) of IR was significantly higher in the GIRD group than in the non-GIRD group (P = .0064). CONCLUSIONS: We have shown that GIRD has significant correlations with several conditions, such as atrophy of the SSP and ISP, weakness of ER strength, enhancement of IR strength, limitation of total ROM, and throwing side, all of which could be important factors for throwing-shoulder injuries.

Clinical experience of the use of reamer irrigator aspirator in Japanese patients: A report of the first 42 cases.

BACKGROUND: A reamer irrigator aspirator (RIA) can be used to harvest substantial amounts of autologous bone and debride the intramedullary canal. Clinical experience using reamer irrigator aspirators in Japan is very limited. The applicability of the reamer irrigator aspirator head with a minimum diameter of 12 mm for Japanese people is often questioned as the Japanese are smaller than Americans and Europeans. There are no reports of complications in Japanese patients. This study aimed to retrospectively review clinical cases and describe reamer irrigator aspirator use in Japanese patients. METHODS: All patients for whom a reamer irrigator aspirator was used during surgery at our hospital between January 2014 and September 2018 were included. The patients' clinical and radiographic data were retrospectively reviewed. RESULTS: Data of 40 patients (42 cases) were collected. The reamer irrigator aspirator was used for bone graft harvesting in 32 cases, intramedullary debridement and irrigation in 9 cases, and reaming for exchange nailing in 1 case. The diameter of the reamer irrigator aspirator reamer head was 12 mm in 22 cases (53.7%), 12.5 mm in 4 cases (9.8%), 13 mm in 9 cases (22.0%), 13.5 mm in 1 case (2.4%), 14.0 mm in 1 case (2.4%), 14.5 mm in 1 case (2.4%), and 15 mm in 4 cases (9.8%). Mean intraoperative bleeding volume was 1158.6 mL (range, 100-3800 mL). We experienced no difficulty inserting the reamer irrigator aspirator into the intramedullary canals and no cases of insertion-related intraoperative fracture. Five cortical perforations (11.9%) were observed on postoperative computed tomography scans, although no patient was symptomatic. One case (2.4%) of postoperative femur fracture occurred. CONCLUSIONS: Reamer irrigator aspirators can be used in Japanese patients. Smaller reamer head sizes were mainly used in our experience. We should manage complications as in previous reports from Western countries.

Migration Measurement of Pins in Postoperative Recovery of the Proximal Femur Fractures Based on 3D Point Cloud Matching.

Background and objectives: Internal fixation is one of the most effective methods for the treatment of proximal femur fractures. The migration of implants after the operation can seriously affect the reduction of treatment and even cause complications. Traditional diagnosis methods can not directly measure the extent of displacement. Methods: Based on the analysis of Hansson pins, this paper proposes a measurement method based on three-dimensional matching, which uses computerized tomography (CT) images of different periods of patients after the operation to analyze the implants' migration in three-dimensional space with the characteristics of fast speed and intuitive results. Results and conclusions: The measurement results show that the method proposed in this paper has more minor errors, more flexible coordinate system conversion, and more explicit displacement analysis than the traditional method of manually finding references in CT images and measuring displacement.

Percutaneous CO2 Treatment Accelerates Bone Generation During Distraction Osteogenesis in Rabbits.

BACKGROUND: Distraction osteogenesis has been broadly used to treat various structural bone deformities and defects. However, prolonged healing time remains a major problem. Various approaches including the use of low-intensity pulsed ultrasound, parathyroid hormone, and bone morphogenetic proteins (BMPs) have been studied to shorten the treatment period with limited success. Our previous studies of rats have reported that the transcutaneous application of CO2 accelerates fracture repair and bone-defect healing in rats by promoting angiogenesis, blood flow, and endochondral ossification. This therapy may also accelerate bone generation during distraction osteogenesis, but, to our knowledge, no study investigating CO2 therapy on distraction osteogenesis has been reported. QUESTIONS/PURPOSES: We aimed to investigate the effect of transcutaneous CO2 during distraction osteogenesis in rabbits, which are the most suitable animal as a distraction osteogenesis model for a lengthener in terms of limb size. We asked: Does transcutaneous CO2 during distraction osteogenesis alter (1) radiographic bone density in the distraction gap during healing; (2) callus parameters, including callus bone mineral content, volumetric bone mineral density, and bone volume fraction; (3) the newly formed bone area, cartilage area, and angiogenesis, as well as the expression of interleukin-6 (IL-6), BMP-2, BMP-7, hypoxia-inducible factor (HIF) -1α, and vascular endothelial growth factor (VEGF); and (4) three-point bend biomechanical strength, stiffness, and energy? METHODS: Forty 24-week-old female New Zealand white rabbits were used according to a research protocol approved by our institutional ethical committee. A distraction osteogenesis rabbit tibia model was created as previously described. Briefly, an external lengthener was applied to the right tibia, and a transverse osteotomy was performed at the mid-shaft. The osteotomy stumps were connected by adjusting the fixator to make no gap. After a 7-day latency phase, distraction was continued at 1 mm per day for 10 days. Beginning the day after the osteotomy, a 20-minute transcutaneous application of CO2 on the operated leg using a CO2 absorption-enhancing hydrogel was performed five times per week in the CO2 group (n = 20). Sham treatment with air was administered in the control group (n = 20). Animals were euthanized immediately after the distraction period (n = 10), 2 weeks (n = 10), and 4 weeks (n = 20) after completion of distraction. We performed bone density quantification on the plain radiographs to evaluate consolidation in the distraction gap with image analyzing software. Callus parameters were measured with micro-CT to assess callus microstructure. The newly formed bone area and cartilage area were measured histologically with safranin O/fast green staining to assess the progress of ossification. We also performed immunohistochemical staining of endothelial cells with fluorescein-labeled isolectin B4 and examined capillary density to evaluate angiogenesis. Gene expressions in newly generated callus were analyzed by real-time polymerase chain reaction. Biomechanical strength, stiffness, and energy were determined from a three-point bend test to assess the mechanical strength of the callus. RESULTS: Radiographs showed higher pixel values in the distracted area in the CO2 group than the control group at Week 4 of the consolidation phase (0.98 ± 0.11 [95% confidence interval 0.89 to 1.06] versus 1.19 ± 0.23 [95% CI 1.05 to 1.34]; p = 0.013). Micro-CT demonstrated that bone volume fraction in the CO2 group was higher than that in the control group at Week 4 (5.56 ± 3.21 % [95% CI 4.32 to 6.12 %] versus 11.90 ± 3.33 % [95% CI 9.63 to 14.25 %]; p = 0.035). There were no differences in any other parameters (that is, callus bone mineral content at Weeks 2 and 4; volumetric bone mineral density at Weeks 2 and 4; bone volume fraction at Week 2). At Week 2, rabbits in the CO2 group had a larger cartilage area compared with those in the control group (2.09 ± 1.34 mm [95% CI 1.26 to 2.92 mm] versus 5.10 ± 3.91 mm [95% CI 2.68 to 7.52 mm]; p = 0.011). More newly formed bone was observed in the CO2 group than the control group at Week 4 (68.31 ± 16.32 mm [95% CI 58.19 to 78.44 mm] versus 96.26 ± 19.37 mm [95% CI 84.25 to 108.26 mm]; p < 0.001). There were no differences in any other parameters (cartilage area at Weeks 0 and 4; newly formed bone area at Weeks 0 and 2). Immunohistochemical isolectin B4 staining showed greater capillary densities in rabbits in the CO2 group than the control group in the distraction area at Week 0 and surrounding tissue at Weeks 0 and 2 (distraction area at Week 0, 286.54 ± 61.55 /mm [95% CI 232.58 to 340.49] versus 410.24 ± 55.29 /mm [95% CI 361.78 to 458.71]; p < 0.001; surrounding tissue at Week 0 395.09 ± 68.16/mm [95% CI 335.34 to 454.83] versus 589.75 ± 174.42/mm [95% CI 436.86 to 742.64]; p = 0.003; at Week 2 271.22 ± 169.42 /mm [95% CI 122.71 to 419.73] versus 508.46 ± 49.06/mm [95% CI 465.45 to 551.47]; p < 0.001 respectively). There was no difference in the distraction area at Week 2. The expressions of BMP -2 at Week 2, HIF1-α at Week 2 and VEGF at Week 0 and 2 were greater in the CO2 group than in the control group (BMP -2 at Week 2 3.84 ± 0.83 fold [95% CI 3.11 to 4.58] versus 7.32 ± 1.63 fold [95% CI 5.88 to 8.75]; p < 0.001; HIF1-α at Week 2, 10.49 ± 2.93 fold [95% CI 7.91 to 13.06] versus 20.74 ± 11.01 fold [95% CI 11.09 to 30.40]; p < 0.001; VEGF at Week 0 4.80 ± 1.56 fold [95% CI 3.43 to 6.18] versus 11.36 ± 4.82 fold [95% CI 7.13 to 15.59]; p < 0.001; at Week 2 31.52 ± 8.26 fold [95% CI 24.27 to 38.76] versus 51.05 ± 15.52 fold [95% CI 37.44 to 64.66]; p = 0.034, respectively). There were no differences in any other parameters (BMP-2 at Week 0 and 4; BMP -7 at Weeks 0, 2 and 4; HIF-1α at Weeks 0 and 4; IL-6 at Weeks 0, 2 and 4; VEGF at Week 4). In the biomechanical assessment, ultimate stress and failure energy were greater in the CO2 group than in the control group at Week 4 (ultimate stress 259.96 ± 74.33 N [95% CI 167.66 to 352.25] versus 422.45 ± 99.32 N [95% CI 299.13 to 545.77]; p < 0.001, failure energy 311.32 ± 99.01 Nmm [95% CI 188.37 to 434.25] versus 954.97 ± 484.39 Nmm [95% CI 353.51 to 1556.42]; p = 0.003, respectively). There was no difference in stiffness (216.77 ± 143.39 N/mm [95% CI 38.73 to 394.81] versus 223.68 ± 122.17 N/mm [95% CI 71.99 to 375.37]; p = 0.92). CONCLUSION: Transcutaneous application of CO2 accelerated bone generation in a distraction osteogenesis model of rabbit tibias. As demonstrated in previous studies, CO2 treatment might affect bone regeneration in distraction osteogenesis by promoting angiogenesis, blood flow, and endochondral ossification. CLINICAL RELEVANCE: The use of the transcutaneous application of CO2 may open new possibilities for shortening healing time in patients with distraction osteogenesis. However, a deeper insight into the mechanism of CO2 in the local tissue is required before it can be used in future clinical practice.

Larger Acetabular Labrum Is Associated With Hip Dysplasia, Joint Incongruence, and Clinical Symptoms.

PURPOSE: To evaluate the association of labral length with acetabular morphology and clinical symptoms. METHODS: Patients treated at our hip joint clinic between January 2015 and December 2018 were retrospectively enrolled in the study. Our sample included patients who received a diagnosis of one or more of the following: hip labral tear, femoroacetabular impingement (FAI), and developmental dysplasia of the hip. Patients with osteoarthritis and/or osteonecrosis were excluded. Bilateral labral length was measured as the distance from the acetabular rim to the edge of the labrum at the level of the central coronal T1-weighted magnetic resonance imaging scan cross-referenced to the axial plane (3- to 9-o'clock position). The lateral center-edge angle (LCEA) and acetabular roof obliquity (ARO) were evaluated with plain radiographs. An LCEA of 25° or less was defined as developmental dysplasia of the hip, whereas a positive crossover sign in the presence of an LCEA of 30° or greater, an LCEA greater than 40°, or acetabular inclination lower 0° was defined as pincer FAI. An alpha angle greater than 50° or head-neck offset lower 8 mm was considered cam FAI. The severity of hip symptoms was evaluated bilaterally using the Japanese Orthopaedic Association pain scale, on which hips scoring full points (i.e., a perfect score) were defined as asymptomatic whereas hips with all other scores were considered symptomatic. We used simple linear regression to examine the correlations of labral length with the LCEA and ARO. Labral length was also compared according to patient hip symptom status using the Mann-Whitney U test. RESULTS: The study included 102 patients (14 with bilateral symptoms and 88 with unilateral symptoms). Labral length was strongly correlated with the LCEA (r = -0.612, P < .001) and ARO (r = 0.635, P < .001). Additionally, patients with symptomatic hips had significantly larger labra (9.5 ± 3.0 mm) than those with asymptomatic hips (7.9 ± 2.1 mm, P = .004). CONCLUSIONS: Acetabular labral length is significantly greater in dysplastic, irregularly congruent, symptomatic hips. LEVEL OF EVIDENCE: Level Ⅳ, retrospective cross-sectional study.

The Influences of Chronicity and Meniscal Injuries on Pivot Shift in Anterior Cruciate Ligament-Deficient Knees: Quantitative Evaluation Using an Electromagnetic Measurement System.

PURPOSE: To investigate the influences of time from injury to surgery and meniscal injuries on knee rotational laxity in anterior cruciate ligament (ACL)-deficient knees using the electromagnetic system retrospectively. METHODS: Ninety-four unilateral ACL-injured patients (44 male and 50 female, mean age: 27.3 ± 11.8 years) were included. The pivot-shift test was performed before ACL reconstruction, as was a quantitative evaluation using the electromagnetic system to determine tibial acceleration. Patients were divided into 4 groups according to the chronicity: group 1, within 3 months (22 patients); group 2, between 3 and 6 months (29 patients); group 3, between 6 and 12 months (23 patients); and group 4, more than 12 months (20 patients). The presence of meniscal injuries was examined arthroscopically. RESULTS: The tibial acceleration was significantly greater in group 4. There was a positive correlation between tibial acceleration and the time from injury to surgery (r = 0.47, P = .02). In groups 1, 2 and 3, the tibial acceleration in patients with a lateral meniscal injury was significantly greater than in patients with a medial meniscal injury and without meniscal injury. When patients with lateral meniscal injury were excluded (leaving those with medial meniscus injury or without meniscal injury), group 4 had significantly greater accelerations than other groups. CONCLUSIONS: In ACL-deficient knees, rotational laxity increased with time and the increased rotational laxity was evident more than 1 year after injury whereas it increased with concomitant lateral meniscal injuries within 1 year after injury. LEVEL OF EVIDENCE: Ⅳ, diagnostic study of nonconsecutive patients.

Varus deformity in the proximal tibia and immediate postoperative varus alignment result in varus progression in limb alignment in the long term after total knee arthroplasty.

PURPOSE: The aim of this study was to examine and evaluate the factors associated with changes in limb alignment 10 years after total knee arthroplasty (TKA). The hypothesis was that bone morphology and immediate postoperative alignment could be correlated with long-term post-operative alignment changes following TKA. METHODS: This study retrospectively analysed 136 consecutive primary TKA cases for varus deformity, performed from 2006 to 2008, that could be followed for at least 10 years postoperatively. Anteroposterior long-leg weight-bearing radiographs were obtained within 1 month and at least 10 years after surgery. The hip-knee-ankle (HKA) angle immediately after surgery was compared with that 10 years later; factors correlating with the change in HKA angle (δHKA) were evaluated. RESULTS: The mean HKA angles were significantly different between immediate and long-term postoperative assessments (0.1° ± 1.9° vs. 1.2° ± 2.9°, p < 0.001). Furthermore, a significant difference was observed in the outlier ratio (> 3° deviation from the 0° of HKA angle) (10% vs. 24%, p = 0.002). δHKA strongly correlated with a higher preoperative tibial plateau tip-to-proximal tibial shaft (TPTPS) angle, higher postoperative HKA angle, lateral distal femoral angle, and lower postoperative medial proximal tibial angle. CONCLUSION: Varus deformity in the proximal part of the tibia, immediate postoperative varus alignment, and varus position of the femoral and tibial components may lead to varus progression in limb alignment in the long term, even 10 years after TKA; the surgeon should, therefore, weigh the risks of leaving a varus alignment during surgery. Moreover, if the preoperative TPTPS angle is high, the alignment may become varus after TKA, even in patients who have acquired neutral alignment. LEVEL OF EVIDENCE: IV.