Introduction. Management of deformity involving limb length discrepancy (LLD) using intramedullary devices offers significant benefits to both patients and clinicians over traditional external fixation. Following the withdrawal of the PRECICE nail, the Fitbone became the primary implant available for intramedullary lengthening and deformity correction within our service. This consecutive series illustrates the advantages and complications associated with the use of this device, and describes a novel technique modification for antegrade intramedullary lengthening nails. Materials & Methods. A retrospective cohort review was performed of patient outcomes after treatment with the Fitbone nail at two tertiary referral limb reconstruction services (one adult, one paediatric) between January 2021 to December 2023. Aetiology, indications, initial and final LLD, use of concomitant rail assisted deformity correction (ORDER), removal time and healing index were assessed. Complications of treatment were evaluated and described in detail, alongside technique modifications to reduce the rate of these complications. Results. 21 nails (18 femoral, 2 tibial, 1 humeral) were inserted in 6 adult and 13 paediatric patients. Post-traumatic and congenital/developmental LLD were the most common indications for surgery in the adult and paediatric cohorts respectively. ORDER was employed in 11 cases (9 femurs and 2 tibias). Treatment goals were achieved in all but one case. Complications included superficial infection, locking bolt migration, periprosthetic fracture and component failure. Seven patients required unplanned returns to theatre. Conclusions. The Fitbone nail is an established option for intramedullary limb lengthening, however its use in the UK has been relatively limited compared to the PRECICE until 2021. Our data helps to define its place for limb lengthening and complex deformity correction in both adult and paediatric patients, including in humeral lengthening and retrograde femoral insertion across an open physis. We have identified important potential risks and novel techniques to simplify surgery and avoid complications

Aims

As an alternative to external fixators, intramedullary lengthening nails (ILNs) can be employed for distraction osteogenesis. While previous studies have demonstrated that typical complications of external devices, such as soft-tissue tethering, and pin site infection can be avoided with ILNs, there is a lack of studies that exclusively investigated tibial distraction osteogenesis with motorized ILNs inserted via an antegrade approach.

Introduction. The FitBone lengthening nail (Orthofix UK) is an intramedullary device licensed for the lengthening of long bones in adults in the UK. It contains a motor powered by electricity transmitted via an induction coil placed underneath the skin. It was developed in Germany two decades ago but uptake in the UK has only started more recently. The aim of this study was to review the first cohort of FitBone lengthening nails in a unit with significant experience of other lengthening nails (including PRECICE and Stryde). Materials & Methods. Demographic, clinical and radiological data was prospectively collected on all FitBone cases starting in February 2022. Accuracy of lengthening rate, patient satisfaction and implant issues were all considered. Complications and learning points were recorded and discussed by the multidisciplinary team involved in the patients care. Results. Eleven lengthening nails were inserted between February and November 2022 (6 right femurs, 5 left femurs). The average patient age was 31 (16–57) with 4 females and 7 males. The average lengthening achieved was 44mm (13– 70) over an average of 59 days (35 to 104). Significant technical issues were encountered in this cohort of patients including slow opening up at osteotomy site (3 requiring speeding up of programme), early consolidation (one requiring re-do osteotomy) and backing out of locking screws (3 out of 11 nails). There were also patient use concerns with difficulty using the motor and the inability to reverse the lengthening without an additional component to the motor. Conclusions. We present the first UK cohort of patients with femoral lengthening using the FitBone implant and device. We highlight the technical and patient issues encountered during this learning curve and propose solutions to avoid these pitfalls

Introduction. There is no doubt that the future of limb lengthening lies with internal lengthening. Complication rates are reduced and patient satisfaction is increased. The evolution of internal lengthening peaked with the dual direction, easily inserted and externally controlled PRECICE Nail. It has excelled in performance in accuracy and satisfaction. Its versatility increased with smaller sizes and increased excursion. A field safety notice was issued was issued in October 2021 by the parent company NuVasive. The advice was monitoring of current cases and a hold on implantation until after a review of process. At the National Orthopaedic Hospital Cappagh we elected to remove all implanted nails and assess the nail integrity and physiological changes associated with implantation. Materials & Methods. All patients in who a retained Precice nail at the time of the field safety notice were identified. Patients and families were contacted to explain the issued safety notice from the company and explain that we would be scheduling them for nail removal. This was part of our standard care but we prioritised this group on our waiting list. Consent was obtained for nail removal but also for histological assessment of canal scrapings, blood ion level analysis and independent assessment of the retrieved nail by our academic collaborators at University College Dublin. Ion levels were then repeated at an interval post removal with consent. Results. We identified 7 Precice nails in 5 patients still implanted. All patients had consolidated after lengthening and were ready for nail removal. Elevated Titanium blood ion levels were identified at the time of retrieval. Histological abnormalities consistent with metalosis were identified. In all cases the nail was grossly intact and examination of the motor showed no evidence of wear or failure. Follow up ion levels obtained post retrieval showed persistent elevation. Conclusions. Our retrieval audit shows persistent elevation of Titanium ion levels and abnormal histology despite apparent nail integrity. These findings require further evaluation in a larger retrieval series to determine if there is a high incidence of this phenomenon and if ion levels have a clinical effect

Introduction. Intramedullary lengthening devices have been in use in older children with closed /open growth plates with good success. This study aims to present the early experience of the FITBONE nail since withdrawal of the PRECICE nail. Materials & Methods. Retrospective analysis of both antegrade and retrograde techniques were utilized. Only patients where union was achieved and full weight bearing commenced were included. The complication rate, length gained, distraction index, weight bearing index (WBI) as well as mechanical axes were analysed. Results. 14 (7 males, 7 females) of a total of 16 (7 males, 7 females) patients with a mean age of 16.9 years with varied diagnosis of LLD were analysed. The mean length gained was 38 mm with an average distraction index of 0,74 mm/day. WBI in these patients on average was 59,6 days/cm lengthened. 6 complications were observed, including two nonunions (successfully treated) and a knee subluxation. Mechanical axis deviation improved from 13,3 mm to 6 mm on average. Overall there has been a nonsignificant tendency for WBI to decrease (Spearman's rank correlation coefficient −0.47, p=0.08) with increasing number of cases done, while no correlation between length gained and WBI (−0.01, p=0.96, respectively) was observed. Some nuances will be discussed. Conclusions. Limb lengthening with the FITBONE nail is relatively safe and efficient, however no significant change was seen in the outcome with previous motorized nails

Aims. Distraction osteogenesis with intramedullary lengthening devices has undergone rapid development in the past decade with implant enhancement. In this first single-centre matched-pair analysis we focus on the comparison of treatment with the PRECICE and STRYDE intramedullary lengthening devices and aim to clarify any clinical and radiological differences. Methods. A single-centre 2:1 matched-pair retrospective analysis of 42 patients treated with the STRYDE and 82 patients treated with the PRECICE nail between May 2013 and November 2020 was conducted. Clinical and lengthening parameters were compared while focusing radiological assessment on osseous alterations related to the nail’s telescopic junction and locking bolts at four different stages. Results. Osteolysis next to the telescopic junction was observed in 31/48 segments (65%) lengthened with the STRYDE nail before implant removal compared to 1/91 segment (1%) in the PRECICE cohort. In the STRYDE cohort, osteolysis initially increased, but decreased or resolved in almost all lengthened segments (86%) after implant removal. Implant failure was observed in 9/48 STRYDE (19%) and in 8/92 PRECICE nails (9%). Breakage of the distal locking bolts was found in 5/48 STRYDE nails (10%) compared to none in the PRECICE cohort. Treatment-associated pain was generally recorded as mild and found in 30/48 patients (63%) and 39/92 (42%) in the STRYDE and PRECICE cohorts, respectively. Temporary range of motion (ROM) limitations under distraction were registered in 17/48 (35%) segments treated with the STRYDE and 35/92 segments (38%) treated with the PRECICE nail. Conclusion. Osteolysis and periosteal reaction, implant breakage, and pain during lengthening and consolidation is more likely in patients treated with the STRYDE nail compared to the PRECICE nail. Temporary ROM limitations during lengthening occurred independent of the applied device. Implant-related osseous alterations seem to remodel after implant removal. Cite this article: Bone Joint J 2023;105-B(1):88–96

Aims

The aim of this retrospective cohort study was to assess and investigate the safety and efficacy of using a distal tibial osteotomy compared to proximal osteotomy for limb lengthening in children.

Introduction. Motorised intramedullary lengthening nails are considered more expensive than external fixators for limb lengthening. This research aims to compare the cost of femoral lengthening in children using the PRECICE magnetic lengthening nail with external fixation. Materials and Methods. Patients: Retrospective analysis of 50 children who underwent femoral lengthening. One group included patients who were treated with PRECICE lengthening nails, the other group included patients who had lengthening with external fixation. Each group included 25 patients aged between 11–17 years. The patients in both groups were matched for age. Cost analysis was performed following micro-costing and analysis of the used resources during the different phases of the treatments. Results. : Each group's mean patient age was 14.7 years. Lengthening nails were associated with longer operative times compared to external fixators, both for implantation and removal surgery (P-value 0.007 and <0.0001 respectively). Length of stay following the implantation surgery, frequency of radiographs, frequency of outpatient department appointments were all more favourable with lengthening nails. The overall cost of lengthening nails was £1393 more than external fixators, although this difference was not statistically significant (P-value 0.088). Conclusions. The cost of femoral lengthening with lengthening nails was not significantly higher than the external fixators’ cost. Further research to review the effectiveness of the devices and the quality of life during the lengthening process is crucial for robust health economic evaluation

Abstract

MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods.

Cite this article: Bone Jt Open 2022;3(2):155–157.

Aims. Limb-lengthening nails have largely replaced external fixation in limb-lengthening and reconstructive surgery. However, the adverse events and high prevalence of radiological changes recently noted with the STRYDE lengthening nail have raised concerns about the use of internal lengthening nails. The aim of this study was to compare the prevalence of radiological bone abnormalities between STRYDE, PRECICE, and FITBONE nails prior to nail removal. Methods. This was a retrospective case series from three centres. Patients were included if they had either of the three limb-lengthening nails (STYDE, PRECICE, or FITBONE) removed. Standard orthogonal radiographs immediately prior to nail removal were examined for bone abnormalities at the junction of the telescoping nail parts. Results. In total, 306 patients (168 male, 138 female) had 366 limb-lengthening nails removed. The mean time from nail insertion to radiological evaluation was 434 days (36 to 3,015). Overall, 77% of STRYDE nails (20/26) had bone abnormalities at the interface compared with only 2% of FITBONE (4/242) and 1% of PRECICE nails (1/98; p < 0.001). Focal osteolysis in conjunction with periosteal reaction at the telescoping interface was only observed in STRYDE nails. Conclusion. Bone abnormalities at the interface of telescoping nail parts were seen in the majority of STRYDE nails, but only very rarely with FITBONE or PRECICE nails. We conclude that the low prevalence of radiological changes at the junctional interface of 242 FITBONE and 98 PRECICE nails at the time of nail removal does not warrant clinical concerns. Cite this article: Bone Joint J 2021;103-B(11):1731–1735

Aims. The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. Methods. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. Results. All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate – severe junction corrosion. Conclusion. We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: Bone Jt Open 2021;2(8):599–610

Aims. This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. Methods. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed. Results. Adjacent to the nail’s telescoping junction, osteolytic changes were observed in bi-planar radiographs of 20/57 segments (35%) after a mean of 9.5 months (95% confidence interval 7.2 to 11.9) after surgery. A total of 8/20 patients with osseous alterations (40%) reported rest and ambulation pain of the lengthened segment during consolidation. So far, 24 Stryde nails were retrieved and in 20 (83%) macroscopic corrosion was observed at the nail’s telescoping junction. Before implant removal 11/20 radiographs (55%) of lengthened segments with these 20 nails revealed osteolysis. Implant retrieval analysis by means of SEM showed pitting and crevice corrosion. EDX detected chromium as the main metallic element of corrosion. Conclusion. Patients are exposed to the risk of implant-related osteolysis of unclear short- and long-term clinical consequences. The authors advocate in favour of an early implant removal after osseous consolidation. Cite this article: Bone Joint Res 2021;10(7):425–436

Aims. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited regarding outcomes and potential problems. We report on our early experience and raise awareness for the potential of adverse effects from this device. Methods. This is a retrospective review of prospective data collected on all patients treated in our institution using this implant. We report the demographics, nail accuracy, reliability, consolidation index, and cases where concerning clinical and radiological findings were encountered. There were 14 STRYDE nails implanted in nine patients (three male and six female) between June 2019 and September 2020. Mean age at surgery was 33 years (14 to 65). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. Results. At the time of reporting, eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localized pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusion. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered concerning clinical and radiological findings in several patients. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally. Cite this article: Bone Joint J 2021;103-B(6):1168–1172

Introduction. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited with regards to both outcomes and potential issues. In this paper we report on our early experience and raise awareness for the potential of adverse effects from this device. Materials and Methods. This is a review of all patients treated in our institution using this implant. Data were prospectively recorded. We report on demographics, nail accuracy, reliability, consolidation index and cases where concerning clinical and radiological findings were encountered. Results. 14 Stryde nails were implanted in nine patients (three males and six females) between June 2019 and September 2020. Mean age at surgery was 33 years old (14–65 years old). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. By the time of this report eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localised pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusions. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered cases with concerning clinical and radiological findings. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally

Introduction. We have previously published limb lengthening using external fixation in pathological bone diseases. We would like to report a case series of femoral lengthening using the PRECICE system in a similar pathological group especially looking at it's feasibility and complications. Materials and Methods. This is a case series of four patients, two patients with osteogenesis imperfecta and two with Ollier's disease, who underwent femoral lengthening via distraction osteogenesis using the PRECICE intramedullary nail system. It was a retrospective study from a prospective database from clinical records and radiographs. Results. The mean age at the time of surgery was 15.5 years, the mean preoperative leg length discrepancy was 30mm, and the mean distraction distance achieved was 28.75mm. Since these patients were of shorter heigh, limb lengthening was considered. All 4 patients had successful insertion of the nail. The outcomes noted from the 4 patients are collated, with several complications occurring including delayed femoral union, fixed flexion deformity of the hip, persisting pain and quadriceps weakness. Those with Ollier's disease underwent an increased rate of distraction to prevent premature healing. The implications of long-term bisphosphonate therapy in OI are discussed with regards to the risk of delayed femoral union and intra-operative fracture. Conclusions. Intramedullary femoral lengthening in pathological bone disease is possible, but the surgeon needs to give attention to certain details. The regenerate formation is based on the background pathology irrespective of the hardware used. There is much more compliance with the nail technique

Introduction. Pixel Value Ratio (PVR) is a radiographic measure of the relative density of the regenerate to the adjacent bone. This has been reported as an objective criterion for regenerate healing and a guide for when to allow full weight bearing (FWB) in lengthening with intramedullary telescopic nails. The threshold for which magnitude of PVR is adequate to allow bearing full weight is not yet agreed. The aim of this study was to identify from our cohort of adult limb lengthening patients the time to FWB following lengthening, the PVR at this point, and how this compared with the recommended values in the literature. Materials and Methods. A retrospective database review identified 30 adult patients treated with the PRECICE femoral nail by two senior authors. Time from completion of lengthening to instruction to fully weight bear was noted. The PVR was calculated for each cortex on plain radiographs taken at each postoperative visit following completion of lengthening. Significance was set at p <0.05. Results. The median age was 30.5 years (IQR 22.5 – 42.5), 19 male and 11 female patients were included. The underlying cause of shortening was post traumatic in 12 (40%) with the remaining due to a wide variety of causes including congenital, infective, and idiopathic leg length discrepancies. Twenty-two nails were antegrade and the mean distance lengthened was 42 mm. Median time from completion of lengthening to full weight bearing was 42 days (IQR 28 – 69). The overall mean PVR at FWB was 0.79. Each surgeon had differing protocols for weightbearing, however there was no statistical difference between time to weight bearing, nor the mean PVR at FWB. There were no implant failures, shortening, or regenerate fractures. Conclusions. We report on our cohort of adult patients treated with intramedullary lengthening nails with a mean PVR of 0.79 at time of full weightbearing. This is considerably lower than the values reported in the literature ranging from 0.90 to 0.93. We therefore suggest that weightbearing following lengthening nails can be permitted earlier than previously reported without an increased risk of complication