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

We undertook a retrospective study of 50 consecutive patients (41 male, 9 female) with an infected nonunion and bone defect of the femoral shaft who had been treated by radical debridement and distraction osteogenesis. Their mean age was 29.9 years (9 to 58) and they had a mean of 3.8 (2 to 19) previous operations. They were followed for a mean of 5.9 years (2.0 to 19.0). The mean duration of the distraction osteogenesis was 24.5 months (2 to 39). Pin-track infection was observed in all patients. The range of knee movement was reduced and there was a mean residual leg-length discrepancy of 1.9 cm (0 to 8) after treatment. One patient required hip disarticulation to manage intractable sepsis. In all, 13 patients had persistant pain. Bony union was achieved in 49 patients at a mean of 20.7 months (12 to 35). Although distraction osteogenesis is commonly used for the treatment of infected femoral nonunion with bone defects, it is associated with a high rate of complications

Distraction osteogenesis (callotasis) has been widely used in patients with limb-length inequality or massive bone defects. This procedure, however, may be associated with a high incidence of physical and psychosocial complications. Callotasis telescoping on a locked intramedullary nail has been used to shorten the period of external fixation. Little attention has been given to the use of locked intramedullary nails in the treatment of complications after callotasis. Between 1990 and 1999, we used locked intramedullary nailing in 27 patients for the treatment of complications after distraction osteogenesis. There were 17 men and ten women with a mean age of 33.2 years (16 to 66). The nail was inserted at a mean of 3.4 weeks (0 to 15) after removal of the external fixator. Simultaneous autogenous bone grafting and soft-tissue reconstruction were also undertaken in seven and two patients, respectively. There was consolidation of the callus or docking site in all patients at a mean of 6.4 months (2 to 14) after surgery. The mean shortening of the callus was 0.7 cm (0 to 2.5). Two patients had infection at the site of a distal screw which resolved after removal of the nail. In 17 patients the nail was removed at a mean of 26 months after its insertion. Locked intramedullary nails are useful in treating complications after distraction osteogenesis in skeletally mature patients. The risk of infection should be borne in mind

We reviewed 173 patients undergoing distraction osteogenesis to determine the incidence, location and timing of fractures occurring as a complication of the procedure. There were 17 fractures in 180 lengthened segments giving an overall rate of fracture of 9.4%. Unexpectedly, the pattern and location of the fractures were very variable; six were within the regenerate itself, six at the junction between the regenerate and the original bone and five at distant sites in the limb. Of those occurring in the regenerate, five were noted to be associated with compression and partial collapse of the regenerate. In three patients collapse and deformity developed gradually in the distracted segment over the six months after removal of the frame. The method of treatment of these fractures should be chosen to take into account multiple factors, which are additional and often different from those to be considered during management of acute traumatic injuries. Internal fixation appears to be most appropriate for displaced fractures, although in small children, or in those in whom there has been, or is, infection of the screw tracks, a new period of treatment using external fixation may be needed. Fixation by intramedullary nailing was associated with a risk of infection, even if screw tracks were assessed as healthy at the time of insertion of the nail. Internal fixation with the use of plates is safe for displaced, unstable fractures in children

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In this randomized study, we aimed to compare quality of regenerate in monolateral versus circular frame fixation in 30 patients with infected nonunion of tibia.

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This is a prospective randomised study which compares the radiological and functional outcomes of ring and rail fixators in patients with an infected gap (> 3 cm) nonunion of the tibia.

In this retrospective study we evaluated the method of acute shortening and distraction osteogenesis for the treatment of tibial nonunion with bone loss in 17 patients with a mean age of 36 years (10 to 58). The mean bone loss was 5.6 cm (3 to 10). In infected cases, we performed the treatment in two stages. The mean follow-up time was 43.5 months (24 to 96). The mean time in external fixation was 8.0 months (4 to 13) and the mean external fixator index was 1.4 months/cm (1.1 to 1.8). There was no recurrence of infection. The bone evaluation results were excellent in 16 patients and good in one, while functional results were excellent in 15 and good in two. The complication rate was 1.2 per patient. We conclude that acute shortening and distraction osteogenesis is a safe, reliable and successful method for the treatment of tibial nonunion with bone loss, with a shorter period of treatment and lower rate of complication

Aims. The management of a significant bony defect following excision of a diaphyseal atrophic femoral nonunion remains a challenge. We present the outcomes using a combined technique of acute femoral shortening, stabilized with a long retrograde intramedullary nail, accompanied by bifocal osteotomy compression and distraction osteogenesis with a temporary monolateral fixator. Patients and Methods. Eight men and two women underwent the ‘rail and nail’ technique between 2008 and 2016. Proximal locking of the nail and removal of the external fixator was undertaken once the length of the femur had been restored and prior to full consolidation of the regenerate. Results. The mean lengthening was 7 cm (3 to 11). The external fixator was removed at a mean of 127 days (57 to 220). The mean bone healing index was 28 days/cm and the mean external fixation index was 20 days/cm (11 to 18). There were no superficial or deep infections. Conclusion. This small retrospective study shows encouraging results for a combined technique, enabling compression of the femoral osteotomy, alignment, and controlled lengthening. Removal of the fixator and proximal locking of the nail reduces the risk of complications and stabilizes the femur with the maximum working length of the nail. Cite this article: Bone Joint J 2018;100-B:634–9

Introduction. The management of a significant bone defect following excision of a diaphyseal atrophic femoral non-union remains a challenge. Traditional bone transport techniques require prolonged use of an external fixator with associated complications. We present our clinical outcomes using a combined technique of acute femoral shortening, stabilised with a deliberately long retrograde intramedullary nail, accompanied by bifocal osteotomy compression and distraction osteogenesis to restore segment length utilising a temporary monolateral fixator. Method. 9 patients underwent the ‘rail and nail’ technique for the management of femoral non-union. Distraction osteogenesis was commenced on the 6. th. post-operative day. Proximal locking of the nail and removal of the external fixator was performed approximately one month after length had been restored. Full weight bearing and joint rehabilitation was encouraged throughout. Consolidation was defined by the appearance of 3 from 4 cortices of regenerate on radiographs. Results. 7 males and 2 females of adult age underwent treatment between 2009 and 2016. The mean lengthening was 6.6cm (3–10cm). The external fixator was removed at a mean 123 days (57–220), with an external fixation index of 20 days/cm. The regenerate healing index was 28 days/cm. There were no deep infections. Significant complications were seen in 4 patients including knee stiffness, a foot drop, delayed union of the non-union osteotomy (requiring exchange nailing and bone grafting) and revision nailing due to a prominent proximal tip. Conclusion. The combined over-sized intramedullary nail and external fixator enables compression of the femoral osteotomy, alignment of the bone and controlled lengthening. Once the length has been restored, removal of the external fixator and proximal locking of the nail reduces the risk of complications associated with the fixator and stabilises the femur with the maximum working length of the nail. This small retrospective study demonstrates encouraging results for this complex clinical scenario

Several low energy osteotomy techniques are described in the literature but there is limited evidence comparing healing indices. We present a retrospective review of two techniques to evaluate an optimum method. Method:. Two cohorts of patients underwent osteotomy of the tibia using a Gigli saw (n=15) or DeBastiani corticotomy (n=12) technique. Indications for surgery included limb lengthening and bone transport for defect reconstruction with a minimal distraction of 2 cm. The patient radiographs were anonymised and the regenerate assessed by the two senior authors who were blinded to the osteotomy type. Bone quality was recorded along the anterior, posterior, medial and lateral cortices, graded 1–5 from absent to full consolidation over time in frame. The time to 3 cortices healed/regenerate length was calculated. The time to consolidation of the anterior, posterior, medial and lateral cortices were compared. Results:. The mean 3 cortices index in the Gigli group was 2.0 months/cm and in the DeBastiani group 1.8 months/cm, This was not a significant difference. In both groups anterior bone formation was slower, and in 50% and 33% of the Gigli and DeBastiani groups respectively the anterior cortex did not fully heal by the time of frame removal. Discussion:. Both Gigli saw and DeBastiani corticotomy techniques result in good bone formation following distraction osteogenesis. The anterior tibial cortex consolidates more slowly than the other cortices in both groups. This is likely due to deficient soft tissue cover and direct periosteal damage at time of osteotomy

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

A systematic literature review of distraction osteogenesis (DO) for the primary reconstruction of bone defects following resection of primary malignant tumours of long bones (PMTLB) is presented. Fewer than 50 cases were identified. Most reports relate to benign tumours or secondary reconstructive procedures. The outcomes of our own series of 7 patients is also presented (4 tibiae, 3 femora). All patients had isolated bone lesions without metastases and were assessed through the hospital sarcoma board. Mean follow-up was 59 months (17–144). Mean age was 42 years. Final histologic diagnoses were 3 chondrosarcoma, 2 malignant fibrous histiocytoma, 1 adamantinoma and 1 malignant intraosseous nerve sheath tumour. Mean bone defect after resection was 13.1cm (10–17) and bone transport was the reconstruction method in all. There was one local recurrence of tumour six months post-resection, necessitating amputation. Mean frame index for remaining cases was 30.9 days/cm (15.7–41.6). Complications included pin infection, docking site non-union, premature corticotomy union, soft-tissue infection and minor varus deformity. Six cases remain tumour-free with united, well-aligned bones and good long-term function. We conclude DO provides an effective biologic reconstruction option in select cases of PMTLB

Objective:. To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. Design:. A multicentre two arm patient and assessor double blind RCT. Setting:. Four UK centres (Edinburgh, Belfast, Liverpool, Bristol). Participants:. 62 skeletally mature adults undergoing distraction osteogenesis of 2.5–10cm at the proximal tibia. Patients with metabolic bone disorders were excluded. Interventions:. A metaphysial corticotomy was created and an Ilizarov frame applied. After 7 days, distraction was performed (0.75mm/day). After 1cm of distraction, an ‘ultrasound’ device was used for 20 minutes/day. Patients were randomised to either an active or a placebo (control) ultrasound device. Main outcome measures:. Primary outcome measure: time ready for removal of frame for both intension to treat (ITT) and per protocol (PP). Secondary outcomes: covariates affecting time to frame removal, return to weight bearing (>50% body weight), and compliance with device usage. Results:. 90% patients were managed as PP. There was no difference in time to frame removal for ITT (difference . in favour of control. group- 5.0days/cm, 95% CI −8.2 to18.21; p=0.23) or PP (difference . in favour of control. group-10.1days/cm, 95% CI −3.2 to 23.4; p=0.054). Smoking was the only covariate to increase frame removal time (hazard ratio 0.46, 95% CI 0.22 to 0.96; p=0.04). There was no difference in weight bearing between the two groups, after adjusting for distraction length, for the ITT cohort (p>0.5). The compliance was 78.8% & 81.6% in the PP group and 70.0 & 72.3% in the ITT group for active & control devices respectively. Conclusions:. Contrary to the existing literature, including NICE guidelines, this trial found no difference in bone healing between those who underwent low intensity pulsed ultrasound and those who did not. The trial was sufficiently powerful to demonstrate that smoking had a significantly deleterious effect on bone healing; approximately doubling the healing time

We have reviewed a series of 56 consecutive patients treated by the Ilizarov circular fixator for various combinations of nonunion, malunion and infection of fractures. We used segmental excision, distraction osteogenesis and gradual correction of the deformity as appropriate. Treatment was effective in eliminating 40 out of 46 nonunions and all 22 infections. There were two cases of refracture some months after removal of the frame, both of which healed securely in a second frame. Correction of malunion was good in the coronal plane but there was a tendency to anterior angulation, often occurring in the regenerate bone rather than at the original fracture site, after removal of the frame. This was associated with very slow maturation of regenerate bone in some patients, occurring largely, but not exclusively, in those who smoked heavily. Patients expressed high levels of satisfaction with the outcome, despite relatively modest improvements in pain and function, presumably because their longstanding and intractable nonunion had been treated. None the less, the degree of satisfaction correlated strongly with the degree of improvement in pain and function. We emphasise the importance of a multidisciplinary team in the assessment and support of patients undergoing long and demanding treatment. The Ilizarov method is valuable, but research is needed to overcome the problems of delayed maturation of the regenerate and slow or insecure healing of the docking site

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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.

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This study reviews the use of a titanium mesh cage (TMC) as an adjunct to intramedullary nail or plate reconstruction of an extra-articular segmental long bone defect.

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This study describes the use of the Masquelet technique to treat segmental tibial bone loss in 12 patients.

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.

Tibial nonunion represents a spectrum of conditions which are challenging to treat, and optimal management remains unclear despite its high rate of incidence. We present 44 consecutive patients with 46 stiff tibial nonunions, treated with hexapod external fixators and distraction to achieve union and gradual deformity correction. There were 31 men and 13 women with a mean age of 35 years (18 to 68) and a mean follow-up of 12 months (6 to 40). No tibial osteotomies or bone graft procedures were performed. Bony union was achieved after the initial surgery in 41 (89.1%) tibias. Four persistent nonunions united after repeat treatment with closed hexapod distraction, resulting in bony union in 45 (97.8%) patients. The mean time to union was 23 weeks (11 to 49). Leg-length was restored to within 1 cm of the contralateral side in all tibias. Mechanical alignment was restored to within 5° of normal in 42 (91.3%) tibias. Closed distraction of stiff tibial nonunions can predictably lead to union without further surgery or bone graft. In addition to generating the required distraction to achieve union, hexapod circular external fixators can accurately correct concurrent deformities and limb-length discrepancies.

Cite this article: Bone Joint J 2015;97-B:1417–22.

Heterotopic ossification occurring after the use of commercially available bone morphogenetic proteins has not been widely reported. We describe four cases of heterotopic ossification in patients treated with either recombinant bone morphogenetic protein 2 or recombinant bone morphogenetic protein 7. We found that while some patients were asymptomatic, heterotopic ossification which had occurred around a joint often required operative excision with good results.