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Purpose: To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II. Methods: The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates. Results: Both TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively. Conclusion: In terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups. Registration: Registration was completed at ClinicalTrials.gov NCT03635320. [ABSTRACT FROM AUTHOR]

Although S2 alar‐iliac screw technique has been widely used in spinal surgery, its applicability to pelvic fractures is largely unknown. This study aimed to evaluate the biomechanical stability of S2 alar‐iliac screw and S1 pedicle screw fixation in the treatment of Denis II sacral fractures. Twenty‐eight artificial pelvic fracture models were treated with unilateral lumbopelvic fixation, sacroiliac screw fixation, S2 alar‐iliac screw and S1 pedicle screw fixation, and S2 alar‐iliac screw and contralateral S1 pedicle screw fixation (Groups 1–4, respectively; N = 7 per group). Each model was cyclically tested under increasing axial compression. Optical motion‐tracking was used to assess relative displacement and gap angle, and the number of failure cycles. Relative displacement was significantly smaller in Group 3 than in Groups 1 (p = 0.004) and 4 (p < 0.001) but not significantly different between Groups 3 and 2 (p = 0.290). The gap angle in Group 3 was significantly smaller than that in Group 1 (p = 0.009) on the sagittal plane but significantly larger than that in Group 4 (p = 0.006) on the horizontal plane. A number of failure cycles was significantly higher in Group 3 than in Groups 1 (p = 0.002) and 4 (p = 0.004) but not significantly different between Groups 3 and 2 (p = 0.910). From a biomechanical perspective, S2 alar‐iliac screw and S1 pedicle screw fixation can provide good stability in the treatment of Denis II sacral fractures. [ABSTRACT FROM AUTHOR]

Introduction: Perioperative blood transfusion is not without risk and effort should be made to limit patients' exposure to allogeneic blood. However, there is conflicting data regarding the impact of anaemia on postoperative recovery in patients with repaired hip fractures. It is hypothesised that for a given baseline functional status and fracture type, lower postoperative haemoglobin will increase rehabilitation time and prolong total length of hospital stay. Methods: This is a retrospective study on data collected prospectively on patients entered into the Clinical Pathway aged >65 years admitted to Queen Mary Hospital (QMH) with a fractured neck of femur during 2011–2013. Potential predictor variables were analysed with linear regression with respect to total length of stay and those that reached a significance level of 0.05 were included in further analysis. Results: 1092 patients were admitted to QMH with a suspected fractured neck of femur; data from 747 patients were analysed. The fracture sites were neck of femur (50%), intertrochanteric (48%) and subtrochanteric fracture (2%). Approximately 30% of patients received blood transfusions. Of these only the development of postoperative medical complications statistically prolonged hospital stay. No relationship was seen with haemoglobin levels cut-off above and below 10 g/dl with the result remaining non-significant down to a cut-off of above and below 8 g/dl. Discussion: This study revealed that post-surgical haemoglobin level of between 8 g/dl and 10 g/dL did not have an impact on the total length of hospital stay. The development of postoperative medical complications was the only factor that prolonged the total length of stay. [ABSTRACT FROM AUTHOR]

ABSTRACT: A novel computational model of implant migration in trabecular bone was developed using smoothed‐particle hydrodynamics (SPH), and an initial validation was performed via correlation with experimental data. Six fresh‐frozen human cadaveric specimens measuring 10 × 10 × 20 mm were extracted from the proximal femurs of female donors (mean age of 82 years, range 75–90, BV/TV ratios between 17.88% and 30.49%). These specimens were then penetrated under axial loading to a depth of 10 mm with 5 mm diameter cylindrical indenters bearing either flat or sharp/conical tip designs similar to blunt and self‐tapping cancellous screws, assigned in a random manner. SPH models were constructed based on microCT scans (17.33 µm) of the cadaveric specimens. Two initial specimens were used for calibration of material model parameters. The remaining four specimens were then simulated in silico using identical material model parameters. Peak forces varied between 92.0 and 365.0 N in the experiments, and 115.5–352.2 N in the SPH simulations. The concordance correlation coefficient between experimental and simulated pairs was 0.888, with a 95%CI of 0.8832–0.8926, a Pearson ρ (precision) value of 0.9396, and a bias correction factor Cb (accuracy) value of 0.945. Patterns of bone compaction were qualitatively similar; both experimental and simulated flat‐tipped indenters produced dense regions of compacted material adjacent to the advancing face of the indenter, while sharp‐tipped indenters deposited compacted material along their peripheries. Simulations based on SPH can produce accurate predictions of trabecular bone penetration that are useful for characterizing implant performance under high‐strain loading conditions. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1114–1123, 2018. [ABSTRACT FROM AUTHOR]

ABSTRACT: Developing effective treatment for osteoarthritis (OA), a prevalent and disabling disease, has remained a challenge, primarily because of limited understanding of its pathogenesis and late diagnosis. In the subchondral bone, rapid bone loss after traumatic injuries and bone sclerosis at the advanced stage of OA are well‐recognized hallmarks of the disease. Recent studies have further demonstrated the crucial contribution of subchondral bone in the development of OA. However, the microstructural basis of these bone changes has not been examined thoroughly, and the paradox of how abnormal resorption can eventually lead to bone sclerosis remains unanswered. By applying a novel microstructural analysis technique, individual trabecula segmentation (ITS), to micro‐computed tomography (μCT) images of human OA knees, we have identified a drastic loss of rod‐like trabeculae and thickening of plate‐like trabeculae that persisted in all regions of the tibial plateau, underneath both severely damaged and still intact cartilage. The simultaneous reduction in trabecular rods and thickening of trabecular plates provide important insights to the dynamic and paradoxical subchondral bone changes observed in OA. Furthermore, using an established guinea pig model of spontaneous OA, we discovered similar trabecular rod loss and plate thickening that preceded cartilage degradation. Thus, our study suggests that rod‐and‐plate microstructural changes in the subchondral trabecular bone may play an important role in the development of OA and that advanced microstructural analysis techniques such as ITS are necessary in detecting these early but subtle changes. With emerging high‐resolution skeletal imaging modalities such as the high‐resolution peripheral quantitative computed tomography (HR‐pQCT), trabecular rod loss identified by ITS could potentially be used as a marker in assessing the progression of OA in future longitudinal studies or clinical diagnosis. © 2017 American Society for Bone and Mineral Research. [ABSTRACT FROM AUTHOR]

Bone defects caused by trauma have become increasingly common in aged populations. Clinically, because of the relatively decreased bone healing capacity compared with the youth adults, bone defect repair in the elderly remains challenging. The development of effective biomaterials targeted at bone defects in the elderly is a key component of bone-tissue engineering strategies. However, little attention has been paid to bone regeneration in the elderly. Here, we developed a new scaffold chitosan-Strontium chondroitin sulfate (CH-SrCS) and evaluated its effect on improving bone regeneration. We find that the CH-SrCS scaffold displayed positive effects on downregulation of inflammation and osteoclastogenesis related mRNA expressions while demonstrating a significant increase in the expression level of BMP2. Finally, we show that the bone defects healing effects as assessed using an aged rats' bone defects model. Ultimately, this work also provides insights into the design of effective biomaterials targeted at bone defects in the elderly., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

To prevent the attachment of bacteria to implant surfaces, the 1D zinc oxide nanowire-coating has been successfully developed on material surfaces by using a custom-made hydrothermal approach. The chemical nature, surface topography and wettability of spike-like 1D ZnO nanowire-coating are comprehensively investigated. The anti-adhesive and antimicrobial properties of 1D nanowire-coating are tested against Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli by using in vitro live/dead staining and scanning electron microscopy. We find that the adhesion of bacteria can be reduced via the special spike-like topography and that the release of Zn(2+) ions can help suppress the growth of attached bacteria. Furthermore, the antimicrobial effect is also evaluated under in vivo conditions by using a rat model infected with bioluminescent S. aureus. The amount of live bacteria in the rat implanted with a nanowire-coated sample is less than that of the control at various time points. Hence, it is believed that the nanowire-coated material is promising for application in orthopaedic implantation after the long-term animal studies have been completed., (Copyright © 2016 Elsevier B.V. All rights reserved.)

A newly developed magnesium implant is used to stimulate bone formation in vivo. The magnesium implant after undergoing dual aluminum and oxygen plasma implantation is able to suppress rapid corrosion, leaching of magnesium ions, as well as hydrogen gas release from the biodegradable alloy in simulated body fluid (SBF). No released aluminum is detected from the SBF extract and enhanced corrosion resistance properties are confirmed by electrochemical tests. In vitro studies reveal enhanced growth of GFP mouse osteoblasts on the aluminum oxide coated sample, but not on the untreated sample. In addition to that a small amount (50 ppm) of magnesium ions can enhance osteogenic differentiation as reported previously, our present data show a low concentration of hydrogen can give rise to the same effect. To compare the bone volume change between the plasma-treated magnesium implant and untreated control, micro-computed tomography is performed and the plasma-treated implant is found to induce significant new bone formation adjacent to the implant from day 1 until the end of the animal study. On the contrary, bone loss is observed during the first week post-operation from the untreated magnesium sample. Owing to the protection offered by the Al2O3 layer, the plasma-treated implant degrades more slowly and the small amount of released magnesium ions stimulate new bone formation locally as revealed by histological analyses. Scanning electron microscopy discloses that the Al2O3 layer at the bone-implant interface is still present two months after implantation. In addition, no inflammation or tissue necrosis is observed from both treated and untreated implants. These promising results suggest that the plasma-treated magnesium implant can stimulate bone formation in vivo in a minimal invasive way and without causing post-operative complications., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: To determine the clinical results of locking plate system in the treatment of distal radial fractures., Methods: From May 2004 to November 2006, 75 patients were treated with 2.4 mm locking plate system. There were 41 males and 34 females, with a mean age of 51 years old (range, 13-82 years old). The locations were left side in 34 cases and right side in 41 cases. The cause of injury was a low energy fall in 49 cases, falling from height in 14 cases, traffic accident in 6 cases and sports injuries in 6 cases. All patients were diagnosed as having closed fracture. According to Müller-AO classification, there were 14 cases(18.7%) of type A, 5 cases(6.7%) of type B, and 56 cases(74.6%) of type C. The time from injury to operation was 5 hours to 27 days (mean 6 days)., Results: A total of 75 patients were followed up at 3 months, 71 patients at 6 months, 68 patients at 1 year and 51 patients at 2 years. Healing by first intention of incision was achieved in 73 cases, and infection occurred in 2 cases. Fracture reduction failed at 1 month, 3 months and 6 months in 1 case, respectively; 1 case received plaster fixation and 2 cases received re-fixation and autograft of ilium; and fracture healed in 3 cases at last follow-up. Two patients complained of skin numbness at site of superficial branch of radial nerve after 1 day, 1 patient had wound pain after operation, and 1 patient had infection of tendon at 3 days and 5 days in 1 case respectively. At last follow-up, the ranges of motion of wrist joint were (80 +/- 9) degrees for pronation, (86 +/- 7) degrees for supination, (57 +/- 10) degrees for dorsal flexion, (51 +/- 13) degrees for palmar flexion, (18 +/- 7) degrees for radial inclination, and (28 +/- 7) degrees for ulnar deviation. According to modified Green scoring, the results were excellent in 66 cases, good in 6 cases and poor in 3 cases. At last follow-up, according to Knirk criterion for osteoarthritis, there were 22 cases of grade I and 5 cases of grade II, and all were classified as type C., Conclusion: Internal fixation of distal radial fractures with 2.4 mm locking plate system provided a stable fixation with good clinical outcomes.

Objective: To evaluate the application of minimally invasive plate osteosynthesis (MIPO) technique in treatment of distal tibia fractures with locking compression plate (LCP)., Methods: From August 2002 to August 2007, 62 subjects were recruited (36 males and 26 females) at mean age of 44 years old (range, 21-87 years old). According to AO classification, there were 8 cases of type A1, 15 cases of type A2, 9 cases of type A3, 7 cases of type B3, 11 cases of type C1, and 12 cases of type C2. Of them, 52 patients had closed fractures and 10 had open fractures. Ten open fractures included 6 Grade I fracture and 4 Grade II fracture. The time from injury to operation was 8 hours to 6 days. The X-ray films were taken after 3 months of operation., Results: Near anatomical reduction was achieved in 56 fractures and acceptable reduction in 6 fractures. Mean operation time was 43 minutes (range, 37-120 minutes). Primary healing of surgical wounds was observed in all cases. Subjects were followed up for 23 months on average (ranged, 18-45 months). All fractures healed with a mean healing time of 19.5 weeks (range, 16-32 weeks). According to Teens and Wiss ankle scoring system, 30 patients got excellent results, 25 good, and 7 fair; and the excellent and good rate was 88.7% at 12-month follow-up. There were 7 cases of delayed soft tissue infection which needed implant removal. There was one complication of compartment syndrome which required fasciotomy. There was one case with loss of reduction (valgus tilting of tibial plafond) that required bone grafting., Conclusion: The results of MIPO LCP in treatment of distal tibia fractures were satisfactory. This technique was safe with no incidence of serious complications.

Objective: To evaluate the clinical and radiological outcomes of minimally invasive plate osteosynthesis (MIPO) with locking compression plate (LCP) in the treatment of proximal humeral shaft fracture., Methods: From July 2004 to April 2008, 26 patients with displaced fractures of the proximal humeral shaft were recruited, including 8 males and 18 females. Age of patients averaged 66 years old (range, 34-82 years old). According to AO classification, there were 4 cases of type A1, 2 cases of type A2, 8 cases of type B1, 4 cases of type B2, 2 cases of type B3, 4 cases of type C1 and 2 cases of type C2. The time from injury to surgery averaged 2 days (range, 1-5 days). There were 8 osteoporotic fractures., Results: All surgical wound healed primarily, and there was no wound infection. Three patients had postoperative radial nerve neurapraxia, which recovered at 4, 6, 8 months respectively. All patients were followed up for 6-24 months with an average of 14.1 months. Radiological examination revealed bony union within 6 months in 25 cases. There was 1 delayed union which remained asymptomatic and eventually healed at 8 months with acceptable Constant-Murley score. There were 3 cases of shoulder impingement syndrome diagnosed at 3 months post-operatively. After implant removal, they all achieved an acceptable Constant-Murley score. According to Constant-Murley scoring system, there were 11 excellent, 10 good and 5 acceptable results. The excellent or good rate was 80.8%., Conclusion: MIPO technique using LCP is an effective method to treat proximal humeral shaft fractures, which facilitates functional recovery of the shoulder joint. During the surgery, it is important to achieve a good fracture reduction and to avoid complications.