In an interdisciplinary project involving electronic engineers and clinicians, a telemetric system was developed to measure the bending load in a titanium internal femoral fixator. As this was a new device, the main question posed was: what clinically relevant information could be drawn from its application? As a first clinical investigation, 27 patients (24 men, three women) with a mean age of 38.4 years (19 to 66) with femoral nonunions were treated using the system. The mean duration of the nonunion was 15.4 months (5 to 69). The elasticity of the plate-callus system was measured telemetrically until union. Conventional radiographs and a CT scan at 12 weeks were performed routinely, and healing was staged according to the CT scans. All nonunions healed at a mean of 21.5 weeks (13 to 37). Well before any radiological signs of healing could be detected, a substantial decrease in elasticity was recorded. The relative elasticity decreased to 50% at a mean of 7.8 weeks (3.5 to 13) and to 10% at a mean of 19.3 weeks (4.5 to 37). At 12 weeks the mean relative elasticity was 28.1% (0% to 56%). The relative elasticity was significantly different between the different healing stages as determined by the CT scans. Incorporating load measuring electronics into implants is a promising option for the assessment of bone healing. Future application might lead to a reduction in the need for exposure to ionising radiation to monitor fracture healing

This article presents a unified clinical theory that links established facts about the physiology of bone and homeostasis, with those involved in the healing of fractures and the development of nonunion. The key to this theory is the concept that the tissue that forms in and around a fracture should be considered a specific functional entity. This ‘bone-healing unit’ produces a physiological response to its biological and mechanical environment, which leads to the normal healing of bone. This tissue responds to mechanical forces and functions according to Wolff’s law, Perren’s strain theory and Frost’s concept of the “mechanostat”. In response to the local mechanical environment, the bone-healing unit normally changes with time, producing different tissues that can tolerate various levels of strain. The normal result is the formation of bone that bridges the fracture – healing by callus. Nonunion occurs when the bone-healing unit fails either due to mechanical or biological problems or a combination of both. In clinical practice, the majority of nonunions are due to mechanical problems with instability, resulting in too much strain at the fracture site. In most nonunions, there is an intact bone-healing unit. We suggest that this maintains its biological potential to heal, but fails to function due to the mechanical conditions. The theory predicts the healing pattern of multifragmentary fractures and the observed morphological characteristics of different nonunions. It suggests that the majority of nonunions will heal if the correct mechanical environment is produced by surgery, without the need for biological adjuncts such as autologous bone graft. Cite this article: Bone Joint J 2016;98-B:884–91

Objectives. The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. Materials and Methods. An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur. Results. A total of 39 cases of clinical application were reviewed for this study. In total, four different types of healing curves were observed: fast healing; slow healing; plateau followed by healing; and non-healing. Conclusion. The electronically instrumented internal fixator proved to be valuable for the assessment of bone healing in difficult healing situations. Cost-effective manufacturing is possible because the used electronic components are derived from large-scale production. The incorporation of microelectronics into orthopaedic implants will be an important innovation in future clinical care. Cite this article: B. Kienast, B. Kowald, K. Seide, M. Aljudaibi, M. Faschingbauer, C. Juergens, J. Gille. An electronically instrumented internal fixator for the assessment of bone healing. Bone Joint Res 2016;5:191–197. DOI: 10.1302/2046-3758.55.2000611

Aims. Postoperative malalignment of the femur is one of the main complications in distal femur fractures. Few papers have investigated the impact of intraoperative malalignment on postoperative function and bone healing outcomes. The aim of this study was to investigate how intraoperative fracture malalignment affects postoperative bone healing and functional outcomes. Methods. In total, 140 patients were retrospectively identified from data obtained from a database of hospitals participating in a trauma research group. We divided them into two groups according to coronal plane malalignment of more than 5°: 108 had satisfactory fracture alignment (< 5°, group S), and 32 had unsatisfactory alignment (> 5°, group U). Patient characteristics and injury-related factors were recorded. We compared the rates of nonunion, implant failure, and reoperation as healing outcomes and Knee Society Score (KSS) at three, six, and 12 months as functional outcomes. We also performed a sub-analysis to assess the effect of fracture malalignment by plates and nails on postoperative outcomes. Results. The rates of nonunion and reoperation in group U were worse than those in group S (25.0% vs 14.3%; 15.6% vs 5.6%), but the differences were not significant (p = 0.180 and p = 0.126, respectively). Mean KSS in group U at all follow-up periods was significantly worse that in group S (75.7 (SD 18.8) vs 86.0 (SD 8.7); p < 0.001; 78.9 (SD 17.2) vs 89.1 (SD 9.8); p < 0.001; 85.0 (SD 11.9) vs 91.1 (SD 7.2); p = 0.002, respectively). In the sub-analysis of plates, mean KSS was significantly worse in group U at three and six months. In the sub-analysis of nails, the rate of reoperation was significantly higher in group U (28.6% vs 5.8%; p = 0.025), and mean KSS at six and 12 months was significantly worse in Group U. Conclusion. To obtain good postoperative functional results, intraoperative alignment of the coronal plane should be accurately restored to less than 5°. Cite this article: Bone Jt Open 2022;3(2):165–172

In patients with traumatic brain injury and fractures of long bones, it is often clinically observed that the rate of bone healing and extent of callus formation are increased. However, the evidence has been unconvincing and an association between such an injury and enhanced fracture healing remains unclear. We performed a retrospective cohort study of 74 young adult patients with a mean age of 24.2 years (16 to 40) who sustained a femoral shaft fracture (AO/OTA type 32A or 32B) with or without a brain injury. All the fractures were treated with closed intramedullary nailing. The main outcome measures included the time required for bridging callus formation (BCF) and the mean callus thickness (MCT) at the final follow-up. Comparative analyses were made between the 20 patients with a brain injury and the 54 without brain injury. Subgroup comparisons were performed among the patients with a brain injury in terms of the severity of head injury, the types of intracranial haemorrhage and gender. Patients with a brain injury had an earlier appearance of BCF (p < 0.001) and a greater final MCT value (p < 0.001) than those without. There were no significant differences with respect to the time required for BCF and final MCT values in terms of the severity of head injury (p = 0.521 and p = 0.153, respectively), the types of intracranial haemorrhage (p = 0.308 and p = 0.189, respectively) and gender (p = 0.383 and p = 0.662, respectively). These results confirm that an injury to the brain may be associated with accelerated fracture healing and enhanced callus formation. However, the severity of the injury to the brain, the type of intracranial haemorrhage and gender were not statistically significant factors in predicting the rate of bone healing and extent of final callus formation

We reviewed 59 bone graft substitutes marketed by 17 companies currently available for implantation in the United Kingdom, with the aim of assessing the peer-reviewed literature to facilitate informed decision-making regarding their use in clinical practice. After critical analysis of the literature, only 22 products (37%) had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita), Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question the need for so many different products, especially with limited published clinical evidence for their efficacy, and conclude that there is a considerable need for further prospective randomised trials to facilitate informed decision-making with regard to the use of current and future bone graft substitutes in clinical practice.

Cite this article: Bone Joint J 2013;95-B:583–97.

Aims. To clarify the effectiveness of the induced membrane technique (IMT) using beta-tricalcium phosphate (β-TCP) for reconstruction of segmental bone defects by evaluating clinical and radiological outcomes, and the effect of defect size and operated site on surgical outcomes. Methods. A review of the medical records was conducted of consecutive 35 lower limbs (30 males and five females; median age 46 years (interquartile range (IQR) 40 to 61)) treated with IMT using β-TCP between 2014 and 2018. Lower Extremity Functional Score (LEFS) was examined preoperatively and at final follow-up to clarify patient-centered outcomes. Bone healing was assessed radiologically, and time from the second stage to bone healing was also evaluated. Patients were divided into ≥ 50 mm and < 50 mm defect groups and into femoral reconstruction, tibial reconstruction, and ankle arthrodesis groups. Results. There were ten and 25 defects in the femur and tibia, respectively. Median LEFS improved significantly from 8 (IQR 1.5 to 19.3) preoperatively to 63.5 (IQR 57 to 73.3) at final follow-up (p < 0.001). Bone healing was achieved in all limbs, and median time from the second stage to bone healing was six months (IQR 5 to 10). Median time to bone healing, preoperative LEFS, or postoperative LEFS did not differ significantly between the defect size groups or among the treatment groups. Conclusion. IMT using β-TCP provided satisfactory clinical and radiological outcomes for segmental bone defects in the lower limbs; surgical outcomes were not influenced by bone defect size or operated part. Cite this article: Bone Joint J 2021;103-B(3):456–461

Aims. Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures. Methods. A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages. Results. The meta-analysis included eight studies, 2,285 observations, and 304 events (nonunion). The random effects model predicted a pooled risk ratio (RR) of 3.68 (95% confidence interval 1.87 to 7.23), which can be considered significant (p = 0.003). It indicates that smoking more than triples the risk of nonunion when a fracture is treated conservatively. Conclusion. Smoking confers a RR of 3.68 for developing a nonunion in patients with a displaced middle third clavicle fracture treated conservatively. We know that most patients with pseudarthrosis will have pain and a poor functional outcome. Therefore, patients should be informed of the significantly higher risks of nonunion and offered smoking cessation efforts and counselling. Moreover, surgery should be considered for any patient who smokes with this type of fracture. Cite this article: Bone Joint J 2023;105-B(7):801–807

Aims. The study objective was to prospectively assess clinical outcomes for a pilot cohort of tibial shaft fractures treated with a new tibial nailing system that produces controlled axial interfragmentary micromotion. The hypothesis was that axial micromotion enhances fracture healing compared to static interlocking. Methods. Patients were treated in a single level I trauma centre over a 2.5-year period. Group allocation was not randomized; both the micromotion nail and standard-of-care static locking nails (control group) were commercially available and selected at the discretion of the treating surgeons. Injury risk levels were quantified using the Nonunion Risk Determination (NURD) score. Radiological healing was assessed until 24 weeks or clinical union. Low-dose CT scans were acquired at 12 weeks and virtual mechanical testing was performed to objectively assess structural bone healing. Results. A total of 37 micromotion patients and 46 control patients were evaluated. There were no significant differences between groups in terms of age, sex, the proportion of open fractures, or NURD score. There were no nonunions (0%) in the micromotion group versus five (11%) in the control group. The proportion of fractures united was significantly higher in the micromotion group compared to control at 12 weeks (54% vs 30% united; p = 0.043), 18 weeks (81% vs 59%; p = 0.034), and 24 weeks (97% vs 74%; p = 0.005). Structural bone healing scores as assessed by CT scans tended to be higher with micromotion compared to control and this difference reached significance in patients who had biological comorbidities such as smoking. Conclusion. In this pilot study, micromotion fixation was associated with improved healing compared to standard tibial nailing. Further prospective clinical studies will be needed to assess the strength and generalizability of any potential benefits of micromotion fixation. Cite this article: Bone Jt Open 2021;2(10):825–833

Aims. Demineralised bone matrix (DBM) is rarely used for the local delivery of prophylactic antibiotics. Our aim, in this study, was to show that a graft with a bioactive glass and DBM combination, which is currently available for clinical use, can be loaded with tobramycin and release levels of antibiotic greater than the minimum inhibitory concentration for Staphylococcus aureus without interfering with the bone healing properties of the graft, thus protecting the graft and surrounding tissues from infection. Materials and Methods. Antibiotic was loaded into a graft and subsequently evaluated for drug elution kinetics and the inhibition of bacterial growth. A rat femoral condylar plug model was used to determine the effect of the graft, loaded with antibiotic, on bone healing. Results. We found that tobramycin loaded into a graft composed of bioglass and DBM eluted antibiotic above the minimum inhibitory concentration for three days in vitro. It was also found that the antibiotic loaded into the graft produced no adverse effects on the bone healing properties of the DBM at a lower level of antibiotic. Conclusion. This antibiotic-loaded bone void filler may represent a promising option for the delivery of local antibiotics in orthopaedic surgery. Cite this article: Bone Joint J 2016;98-B:1126–31

Aims. The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis. Patients and Methods. A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame. Results. There was no difference in the time to removal of the frame between the PP (difference in favour of the control group was 10.1 days/cm, 95% confidence interval (CI) -3.2 to 23.4, p = 0.054) or ITT (difference 5.0 days/cm, 95% CI -8.2 to 18.21, p = 0.226) groups. The smoking status was the only covariate which increased the time to removal of the frame (hazard ratio 0.47, 95% CI 0.22 to 0.97, p = 0.042). Conclusion. LIPUS does not influence the rate of bone healing in patients who undergo distraction osteogenesis. Smoking may influence bone healing. . Cite this article: Bone Joint J 2017;99-B:494–502

Introduction. Our unit has extensive experience with the use of Ilizarov circular frames for acute fracture and nonunion surgery. We have observed and analysed fracture healing patterns which question the role of relative stability in fracture healing and we offer limb mechanical axis restoration as a more important determinant. Aim. To assess for the presence of external callus, when only relative stability has been achieved but with anatomical restoration of the mechanical axis (ARMA). Methods. We retrospectively reviewed diametaphyseal proximal and distal tibial fractures treated with Ilizarov frame fixation in our unit between 2009 and 2017. We also reviewed cases where the Ilizarov frame technique had been used for complex femoral and humeral non-unions. Radiographs in 4 views were reviewed to assess bone healing, the presence of external callus and correction of lower limb mechanical axis. Results. 45 tibial plateau fractures, 42 distal tibial fractures and 20 humeral and 3 femoral non-unions were reviewed. Where ARMA was achieved, bone healing was observed to occur without external callus. ARMA proved more challenging in the distal tibia and where ARMA was not achieved external callus was visible during fracture healing. Conclusion. ARMA bone healing is reliable and occurs without formation of external callus, despite relative stability. This would suggest that external callus is produced not in response to just the magnitude of strain but also the direction of strain. Restoration of the mechanical axis is an important step in achieving union and needs to be considered when fixing fractures or treating non-unions

Aims

The aim of the present study was to assess the outcomes of the induced membrane technique (IMT) for the management of infected segmental bone defects, and to analyze predictive factors associated with unfavourable outcomes.

Aim. Previous studies of primary internal fixation of infected non-unions have reported high failure rates. Local antibiotic carriers and coatings have been advocated to reduce infection around implants and allow bone healing. We evaluated the effect of a calcium sulphate/hydroxyapatite antibiotic-loaded composite on bone healing and the eradication of infection in combination with internal fixation. Method. Twelve cases of established infected non-union, with segmental bone loss of up to 1cm were treated using a multidisciplinary protocol. This included; excision, deep sampling, stabilisation, local and systemic antibiotics, and soft-tissue closure. We treated 5 femurs, 4 humeri, 1 tibia and 2 periarticular non-unions at the ankle. Mean age was 59.8 years (34–75) and 9 patients had systemic co-morbidities (C-M Type B hosts). 9 patients had single stage surgery, with 5 IM Nails and 4 plates. Three patients had planned second stage internal fixation after external fixation to correct deformity. Staph. aureus was the commonest pathogen (5 cases) with polymicrobial infection in 3 cases. Results. All 12 patients were infection-free at a mean follow-up of 23 months (range 13–34 months). Union was achieved in 11/12 (92%) with the primary surgery alone. The single failure was the tibial case, who remains with an infection-free, stiff non-union. Conclusion. This protocol offered good results, mainly with a single stage treatment. Primary internal fixation was possible in 9 cases, without recurrent infection. The combination of excision of infected dead bone and a high level of local antibiotics above the Minimum Inhibitory Concentration and Minimum Biofilm Eradication Concentration levels for common bacteria, allowed a high success rate in these difficult cases

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The aim of this study was to assess the safety and clinical outcome of patients with a femoral shaft fracture and a previous complex post-traumatic femoral malunion who were treated with a clamshell osteotomy and fixation with an intramedullary nail (IMN).

Aims

Though most humeral shaft fractures heal nonoperatively, up to one-third may lead to nonunion with inferior outcomes. The Radiographic Union Score for HUmeral Fractures (RUSHU) was created to identify high-risk patients for nonunion. Our study evaluated the RUSHU’s prognostic performance at six and 12 weeks in discriminating nonunion within a significantly larger cohort than before.

Introduction. We investigated the usefulness of flap surgery for Gustilo type IIIB and C severe open fracture of the tibia, for which treatment is difficult. Materials & Methods. The subjects were 16 patients with severe open fracture of the tibia who received a treatment at our division between April 2000 and October 2008. There were 13 males and 3 females, and the mean age at injury was 41.2 years. Radical debridement and temporal external fixation were performed on the day of injury, and soft tissue reconstruction and definitive osteosynthesis were performed within a few days after injury to the best. Results. The affected limb was salvaged in all patients. Primary bone healing was obtained in 13 of the 16 patients, and the mean bone healing time was 5.5 months (3–7 months). The patient with delayed bone healing underwent additional bone grafting and achieved bone healing. Concomitant osteomyelitis occurred in 4 of 16 patinets (25%). Leg shortening was observed in 1 patient, but the shortening was only 2 cm. No patient exhibited 10 or more degrees of angular deformity or malrotation. In addition, relatively good ranges of motion of the knee and ankle joints were maintained, and all patients became able to walk without a stick within 1 year after injury. Discussion & Conclusion. Early flap surgery was effective for severe open fracture of the tibia

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To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial.

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Musculoskeletal infection is a devastating complication in both trauma and elective orthopaedic surgeries that can result in significant morbidity. Aim of this study was to assess the effectiveness and complications of local antibiotic impregnated dissolvable synthetic calcium sulphate beads (Stimulan Rapid Cure) in the hands of different surgeons from multiple centres in surgically managed bone and joint infections.

We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing