A systematic review and meta-analysis:comparing the efficacy of the Ilizarov technique alone with lengthening over a nail for lower extremity bone defects.

PURPOSE: The task faced by surgeons becomes significantly more challenging when they encounter lower extremity bone defects due to a variety of causes requiring lengthening. The most discussed and successful approach is the Illizarov technique, or lengthening over a nail (LON):distraction osteogenesis is also widely performed with monoliteral external fixators and intramedullarylengthening nails have increasingly been used in the last decade. METHODS: The data were collected from PubMed, Cochrane Library, Embase, and the Web of Science for all available studies comparing the outcomes of Ilizarov technique alone and LON technique (from January 1, 1997, to November 30, 2023). The outcomes of interest encompassed the external fixation index (EFI) (month/cm), mean duration of follow-up (MFT) (month), length gained (LG) (cm), consolidation index (CIx) (month/cm), and bone healing index (BHI) (month/cm).Complications include pin tract infection rate (PTI), axial deviation rate (AD), occurrence of intramedullary infection (II), delayed consolidation rate (DC), as well as data categorized into three levels of problems, obstacles, and sequelae based on the severity of complications.Two reviewers independently assessed each study for quality and extracted data. The case-control or respective cohort studies were evaluated using the Newcastle-Ottawa scale (NOS) to determine their techniqueological rigor.The Cochrane Collaboration's risk assessment tool was employed to perform quality evaluations for randomized controlled trials. RESULTS: This review included thirteen studies comprising a total of 629 patients.The external fixation index (month/cm) was significantly smaller in the LON technique compared to the Ilizarov technique alone [Mean Difference(MD) = -29.59, 95% CI -39.68--19.49, P < 0.00001].In terms of the mean follow-up time(month) (MD = -0.92, 95% CI -3.49-1.65, P = 0.57), length gained (cm) (MD = -0.87, 95%CI -2.80-1.07, P = 0.38), consolidation index (month/cm) (MD = 0.66, 95% CI -3.44-4.77, P = 0.75), and bone healing index (month/cm) (MD = -3.33, 95% CI -13.07-6.41, P = 0.5), there were no significant differences observed. The LON technique exhibited a lower incidence of axial deviation [Odds Ratio(OR) = 0.06, 95%CI 0.03-0.16, P < 0.00001] and pin tract infection (OR = 0.30, 95%CI 0.18-0.50, P < 0.00001) compared to the Ilizarov technique alone.The remaining complications, such as intramedullary infection rate (OR = 0.93, 95%CI 0.42-2.06, P = 0.85) and delayed consolidation rate(OR = 0.61, 95%CI 0.20-1.86, P = 0.38), did not exhibit statistically significant differences.Our findings demonstrated that the LON technique results in lower incidences of problems (38.5%vs.58.6%) and sequelae (16.6% vs.30.9%) when compared to the Ilizarov technique alone. However, the rates of obstacles (32.4% vs.32.3%) were comparable between the two methods. CONCLUSIONS: Our findings indicate that patients treated with the LON technique experienced significantly shorter external fixation durations and a lower incidence of complications (e.g., pin tract infections and axial deviation) compared to those treated with the Ilizarov technique alone. Other outcome metrics showed no significant differences between the two techniques. However, the LON technique offers substantial benefits, including reduced external fixation times and increased comfort, which enhance patient compliance. In conclusion, the LON technique is a safe, reliable, and effective method for treating tibial and femoral defects.

Simultaneous correction of leg length discrepancy and angular deformity of the distal femur with retrograde Precice nails: a retrospective analysis of 45 patients.

BACKGROUND AND PURPOSE: Magnetically controlled motorized intramedullary lengthening nails (ILNs) can be employed for simultaneous correction of angular deformities of the distal femur and leg length discrepancy. This spares typical complications of external fixators but requires precise preoperative planning and exact intraoperative execution. To date, its results are insufficiently reported. We aimed to elucidate the following questions: (i) Is acute angular deformity correction and gradual femoral lengthening via a retrograde ILN a reliable and precise treatment option? (ii) What are the most common complications of treatment? METHODS: Acute angular deformity correction and subsequent gradual lengthening of the distal femur with retrograde ILN was retrospectively analyzed in 45 patients (median patient age: 15 years, interquartile range [IQR] 13-19 and median follow-up: 40 months, IQR 31-50). Outcome parameters were accuracy, precision, reliability, bone healing, and complications of treatment. RESULTS: The median distraction was 46 mm (IQR 29-49), median distraction and consolidation index 0.9 mm/day (IQR 0.7-1.0) and 29 days/cm (IQR 24-43), respectively. The median preoperative mechanical axis deviation (MAD) was 30 mm (IQR 23-39) in the varus cohort and -25 mm (IQR -29 to -15) in the valgus cohort and reduced to a mean of 8 mm (standard deviation [SD] 8) and -3 (SD 10), respectively. Accuracy, precision, and reliability of lengthening were 94%, 95% and 96%, respectively. Accuracy and precision of deformity correction were 92% and 89%, respectively. In total, 40/45 of patients achieved distraction with a difference of less than 1 cm from the initial plan and a postoperative MAD ranging from -10 mm to +15 mm. In 13/45 patients unplanned additional surgeries were conducted to achieve treatment goal with nonunion being the most frequent (4/45) and knee subluxation (3/45) the most severe complication. CONCLUSION: Acute deformity correction and subsequent lengthening of the distal femur with retrograde ILN is a reliable and accurate treatment achieving treatment goal in 89% but unplanned additional surgeries in 29% of patients should be anticipated.

Lengthening in congenital posteromedial bowing of tibia: a follow-up series at skeletal maturity.

PURPOSE: Congenital posteromedial bowing (CPMB) of tibia is a rare, usually self-resolving condition that is present at birth. The data on the long-term outcome of lengthening, choice of fixator, outcome in early and late age groups, and complications is sparse, hence the need for this study. METHODS: This retrospective study included 93 patients with 94 affected legs from 1991 to 2023. The patients were categorized into early (under 10 years) and late (10 years or above) intervention groups. Eighteen patients with nineteen lengthening episodes who attained skeletal maturity made the basis of this study and will be discussed in detail. RESULTS: The outcome for the lengthening group at maturity was satisfactory, with 5.53 cm of average length gained per lengthening episode, a mean LLD of 0.31 cm at final follow-up, a mean age of 23.63 years (range 14-38 years), and an average follow-up of 12.51 years (range 3-28 years) post-lengthening, but the procedure was associated with difficulties like ankle stiffness, tibial valgus, pin tract infections, and fractures through regenerate. CONCLUSION: This study represents a large single-centre series on CPMB. We recommend that surgery for lengthening should be done at an older age, close to skeletal maturity, wherever possible to reduce the risk of repeat lengthening procedures. Based on our experience, we recommend the use of a circular fixator. Uniplanar distractors should have an adequate number and spread of Schanz screws in each segment to reduce the risk of valgus malalignment of distracting segments of bone.

Distraction osteogenesis in combined sequential use of external fixation and nailing (lengthening and then nailing): An experimental study in rabbits.

Limb lengthening relies on the process of distraction osteogenesis. The active periosteal bone formation has been detected in clinical practice with a lengthening and then nail (LATN) technique but has not been confirmed by experimental studies to date. The aim of this study is to compare the tissue regeneration of the distraction regenerate during tibial lengthening in rabbits using a LATN technique. This study was performed on 54 mature rabbits of the Soviet Chinchilla breed, which were divided into three groups of 18 animals. In group 1 (control), the tibia was lengthened in an external fixator. In group 2, the LATN technique was modeled and in group 3, lengthening over nail (LON) was modeled. The total duration of the experiment was 45 days. On the 10th, 15th, 20th, 30th, and 45th day X-ray, computed tomography and morphological studies were performed. In the experimental groups (2 and 3), a more pronounced periosteal bone formation in the area of regenerate was noted when compared to group 1. In group 2 (LATN), wide cortical plates were formed from the intermediate and periosteal areas. In this group, the maximum densitometric density values were noted. Endosteal bone formation was preserved in all groups. The LON and LATN techniques, when compared with the classical Ilizarov lengthening, do not demonstrate any deficiency in the tissue regeneration of the bone tissue at the regenerate sites. The most powerful bone structures are formed with the sequential use of the external fixation and nailing (LATN).

Limb salvage reconstruction of the lower limb with complex ankle arthrodesis and magnetic internal lengthening nail.

PURPOSE: With advances in orthopedic implants, the use of intramedullary lengthening devices has gained increasing popularity as an alternative technique compared to lengthening with external fixators, with alleged comparable or better outcomes. The aim of this study is to report our single-center technique and outcomes of combined ankle arthrodesis and proximal tibial lengthening using external fixator with a motorized intramedullary nail, respectively. METHOD: Fourteen patients with post-traumatic advanced ankle arthritis underwent staged ankle arthrodesis with external fixator and proximal tibial lengthening using the PRECICE® ILN. Amount of shortening, length achieved, bone healing index, infection rate, ankle fusion rate, and ASAMI score were evaluated. RESULTS: The average age was 44 years old (range, 30-62). The mean follow up is 70 months (range, 43-121.4). The average amount of limb shortening for patients after ankle fusion was 36.7 mm (18-50) while lengthening was 35.9 mm (range, 18-50). Patients had the nail implanted for an average of 479 days (range, 248-730). Ankle fusions were healed in an average of 178.3 days. There were no surgical infections. All osteotomy-lengthening sites healed after an average 202 days (106-365). The mean bone healing index (BHI) was 56.0 days/cm (21.2-123.6) among the whole cohort. There were no cases of nonunion. ASAMI bone scores were excellent or good among all patients. CONCLUSION: Ankle arthrodesis with external fixation along with proximal tibial lengthening using motorized IMN yielded high rates of fusion and successful lengthening. This technique could be offered as a reasonable alternative to using external fixation for both purposes. LEVEL OF EVIDENCE: Level IV, Retrospective cohort study.

Is posterior vertebral arthrodesis at the end of the electromagnetic rod lengthening program necessary for all patients? Comparative analysis of sixty six patients who underwent definitive spinal arthrodesis and twenty four patients with in situ lengthening rods.

PURPOSE: Magnetically controlled growing rods (MCGR) should be removed or changed at most two years after their implantation in the treatment of patients with early-onset scoliosis (EOS) (Safety notice July 2021). However, in the face of patients at high risk of intraoperative complications and relying on the principle of auto-fusion of the spine, some surgeons would prefer a more wait-and-see attitude. The aim of this study was to report on patients who did not undergo final fusion at the end of the lengthening program with MCGR and to compare them with those who did. METHODS: This was a multicenter study with ten centres. We collected all graduate patients with EOS who had received MCGR between 2011 and 2022. RESULTS: A total of 66 patients had final fusion at the end of the lengthening program and 24 patients kept MCGRs in situ. The mean total follow-up time was 66 months (range, 25.3-109), and the mean follow-up time after final lengthening was 24.9 months (range, 3-67.7). Regarding the main curve and thoracic height, there was no significant difference in the percentage of correction over the whole follow-up between the two groups (p = 0.099, p = 0.176) although there was a significant difference between the end of lengthening and the last follow-up (p < 0.001). After completion of the lengthening program, 18 patients who had final fusion developed 24 of the 26 recorded complications (92.3%). CONCLUSION: Contrary to the manufacturer's published safety notice, not all patients systematically benefited from the removal of the MCGRs. Although arthrodesis significantly improved the scoliotic deformity, no significant difference was found in terms of radiographic outcome between patients who underwent spinal fusion and those who kept the MCGRs in situ.

Radiographs of 366 removed limb-lengthening nails reveal differences in bone abnormalities between different nail types.

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.

Early results from a single centre's experience with the STRYDE nail : a cause for concern?

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.

The STRYDE limb lengthening nail is susceptible to mechanically assisted crevice corrosion: an analysis of 23 retrieved implants.

Background and purpose - We noted several adverse events in patients in whom the first version of the STRYDE limb-lengthening nail (NuVasive Specialized Orthopaedics, San Diego, CA) had been implanted. Pain, osteolysis, periosteal reactions, and cortical hypertrophy at the nail junction were noted. Here, we present the analysis of 23 retrieved STRYDE implants.Materials and methods - We undertook visual inspection of the retrieved nails and screws, mechanical evaluation of the junction, micro-CT analyses, microscopic inspection of the bushing, screws, screw holes, and separated parts of the implants. Positive material identification (PMI) and energy-dispersive X-ray spectroscopy (EDS) were used to analyze the chemical composition. The hardness of the material was also investigated.Results - 20/23 retrieved nails had visible signs of corrosion, i.e., discoloration at the telescopic junction. Micro-CT verified corrosion attacks in 12/12 scanned bushings. Corrosion, predominantly mechanically assisted crevice corrosion, was observed at the locking screws and screw holes in 20/23 nails. Biological material inside the nail was observed in addition to oozing from the junction of 2 nails during hardware removal, which was experimentally reproducible. Notably, the mechanical construction of the bushing changed from PRECICE P2 to STRYDE nails.Interpretation - STRYDE nails are not hermetically sealed, and liquid can pass the bushing. Biodur 108 itself is corrosion resistant; however, mechanically assisted crevice corrosion of the bushing, locking screws, and screw holes may be aggravated due to manufacturing aiming for increased strength and hardness of the alloy.Observing several adverse events, we recently published a nationwide cross-sectional analysis of all 30 STRYDE limb- lengthening nails (NuVasive, Specialized Orthopedics, San Diego, CA) that were implanted in Denmark (Rölfing et al. 2021a). 27/30 STRYDE nails have now been removed and we present data from metallurgical analysis of 23 of the retrieved implants.

Has the Threshold for Epiphysiodesis Versus Lengthening Changed in the Era of Magnetically Controlled Nails?

INTRODUCTION: Limb length discrepancy (LLD) is common in both the pediatric and adult population. Length inequalities can be due to a multitude of etiologies including congenital, developmental, and acquired causes. There has been little consensus on the morbidity of LLD and, as a result, the threshold necessary for treatment of LLD to prevent morbidity. Advances in magnetically controlled lengthening devices achieve greater accuracy and patient satisfaction and create an opportunity to lower the threshold for limb lengthening. DISCUSSION: Asymptomatic LLD is relatively common in both pediatric and adult populations. Only ~10% of the population has equal leg length. LLD of <5 cm may lead to long-term morbidities such as scoliosis, lower back pain, gait abnormalities, stress on hip or knee joint, and lower extremity symptomatic versus asymptomatic osteoarthritis. The teaching in most orthopaedic textbooks is to adjust the shoe if symptomatic for discrepancies up to 2 cm; consider an orthotic, epiphysiodesis, or skeletal shortening for 2.5 to 5 cm; and possible limb reconstruction for >5 cm. The assumption is that there are no long-term consequences of mild LLD. However, data in recent literature show that small discrepancies may contribute to pathologic changes such as pain, gait abnormalities, and osteoarthritis. Major advances have been made in limb lengthening over the past 40 years. The increased accuracy and superior patient satisfaction of the magnetically controlled lengthening nail versus external fixation methods argue for including lengthening for LLD of <5 cm. CONCLUSION: If mild LLD can cause long-term pathology, it is important to counsel families on the full range of options for limb equalization no matter the size of the discrepancy. The evolution in technology and understanding of limb lengthening has provided additional safe surgical options. Therefore, the historic treatment protocol for addressing limb differences may need to include lengthening for smaller discrepancies even <2 cm.