|Year : 2020 | Volume
| Issue : 1 | Page : 13-19
Tibial lengthening evolution: Classic ilizarov, lengthening and then nailing, motorized internal lengthening nail
Austin T Fragomen1, Thomas D Falls2, Jaehee Suh1, Nathan Khabyeh-Hasbani1, S Robert Rozbruch1
1 Limb Lengthening and Complex Reconstruction Service, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, NY, USA
2 Private Practice, Louisville, KY, USA
|Date of Submission||03-Feb-2020|
|Date of Decision||25-Mar-2020|
|Date of Acceptance||02-Apr-2020|
|Date of Web Publication||30-Jun-2020|
Dr. Austin T Fragomen
Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021
Source of Support: None, Conflict of Interest: None
Introduction: Distraction osteogenesis is an effective method for the treatment of congenital and acquired limb length discrepancy. Lengthening and then nailing (LATN) was developed to decrease the time in external fixation. With the advent of motorized internal lengthening nails (MILN), external fixation has been eliminated and lengthening of the tibia has become a less burdensome process for patients. Methods: We performed a retrospective review of three groups of patients: Twenty-four patients (27 tibiae) using MILN, 20 patients (32 tibiae) using LATN and 24 patients (34 tibiae) using a classic Ilizarov technique. Results: In the MILN group, the average bone healing index (BHI) was 1.5 months/cm, with an average BHI of 0.9 months/cm for LATN patients and 1.9 months/cm for classic patients. There was a statistically significant difference among the three groups (P < 0.001). There were no deep infections in the internal lengthening nail group. There were no nonunions, persistent joint contractures, or significant unintended changes in alignment in any of the groups. Discussion: Applied appropriately, all three techniques are effective and lead to healing without any significant deformity. Conclusion: Motorized internal lengthening of the tibia is an effective treatment option. The LATN technique still allows for longer lengthenings and faster healing than MILN, however, it does require an additional surgery and the need to wear an external fixator.
Keywords: Bone healing index, external fixation, ilizarov, intramedullary nail, lengthening, lengthening and then nailing, osteotomy, precice, tibia
|How to cite this article:|
Fragomen AT, Falls TD, Suh J, Khabyeh-Hasbani N, Rozbruch S R. Tibial lengthening evolution: Classic ilizarov, lengthening and then nailing, motorized internal lengthening nail. J Limb Lengthen Reconstr 2020;6:13-9
|How to cite this URL:|
Fragomen AT, Falls TD, Suh J, Khabyeh-Hasbani N, Rozbruch S R. Tibial lengthening evolution: Classic ilizarov, lengthening and then nailing, motorized internal lengthening nail. J Limb Lengthen Reconstr [serial online] 2020 [cited 2022 May 20];6:13-9. Available from: https://www.jlimblengthrecon.org/text.asp?2020/6/1/13/288566
| Introduction|| |
Distraction osteogenesis using the Ilizarov method has been a mainstay for treatment of limb length discrepancy and deformity correction for many years. The original (classic) technique has been modified over time to decrease healing times and make treatment more tolerable. Lengthening and then nailing (LATN) was previously developed to decrease the burden of external fixation time for patients. Other treatments, such as lengthening over a nail (LON) or lengthening and then plating were developed to decrease the external fixation time required, but, like LATN, all require at least one additional surgery. Internal lengthening with a fully implantable lengthening nail has been available for some time; however, previous mechanically actuated devices have been fraught with increased complications., A newer generation of remote controlled magnetic motorized internal lengthening nail (MILN) has been developed and proved successful for treating limb length discrepancy.,, The aim of this study was to compare these three bone lengthening techniques (MILN, LATN, and classic Ilizarov external fixation).
The following questions were asked: (1) What is the bone healing index (BHI) for each of the three lengthening techniques? (2) How well does each technique maintain alignment during lengthening? (3) Do these techniques affect joint motion differently after tibia lengthening?
| Methods|| |
We performed a retrospective, institutional review board (IRB) approved, comparison between three groups of tibial lengthening patients treated by two senior surgeons using MILN, LATN, or classic Ilizarov techniques. Data were reviewed in a retrospective manner from our IRB approved limb lengthening database. For the MILN patients, a review of the patient charts and radiographs was performed for tibial lengthenings. Both unilateral and bilateral lengthening patients were included. Patients were excluded who had surgery primarily for angular deformity correction, who lacked data for review, or who had not completed treatment. The LATN and classic Ilizarov patient data were extracted from previously collected databases used in older investigations. These patients had incomplete charts and radiographs available, and hence, we elected to use the information available from existing data spreadsheets.
There was a mix of etiology for limb length discrepancy in each group, with equal numbers of congenital versus acquired cases in the classic group, but more congenital than acquired cases in both the LATN and MILN groups [Table 1]. There was no significant difference in patient age or length of follow-up between all three groups [Table 2]. The average follow-up in the classic group was 36.8 months (range 7.5–84.3 months). The average follow-up in the LATN group was 36.2 months (range 8.5–69.2 months). The average follow-up in the MILN group was 31.1 months (range 7.6–55.5 months). There was a difference in the amount of lengthening between the groups, with a mean lengthening in the LATN group of 5.7 cm (range 2.5–10 cm). The mean lengthening in the classic group was 3.9 cm (range 1.2–7.5 cm) and a mean of 4.1 cm (range 1.7–6.5 cm) in the MILN group (P < 0.001) [Table 2].
In all cases, a percutaneous osteotomy was performed using fluoroscopy. This was accomplished with a small incision where multiple drill holes were made in one transverse plane with a 4.8-mm drill bit. A 7–10 mm osteotome was used to perform a corticotomy through the same limited incision. A rotational osteoclasis then ensured successful completion of the osteotomy. The distance of the osteotomy to the knee joint was recorded in the MILN cohort with an average of 124 mm (range 80-170 mm). In the LATN group, the distance was not recorded but the surgical protocol was to make the osteotomy 100 mm from the joint line. The classic cohort was the most diverse, and osteotomy site varied significantly based on the apex of the deformity. Lengthening ensued after 7–10 days latency at the rate of 0.75–1.0 mm per day based on radiographic regenerate quality, a practice that was independent of the technique used.
In the classic and LATN groups, patients underwent lengthening using a Taylor spatial frame (TSF) (Smith and Nephew, Memphis, TN, USA) with a mix of tensioned wires and hydroxyapatite coated half pins. Tensioned wires were used to secure the proximal and distal syndesmosis joints. Adjacent joints were not spanned in any of these cases. In the LATN group, fixation was isolated to the metaphyseal regions of the bone for later insertion of a reamed, intramedullary (IM) tibial nail. The fixation elements were aimed away from the IM canal for later nail insertion with the frame in place. At the end of distraction, an infra-patellar approach was used to insert a locked IM nail. The nail was modified to include an additional proximal locking hole closer to the Herzog bend to allow for locking without interference from the Schantz pins proximally. The targeting arm for proximal locking was also modified to fit over the proximal tibial ring. The Biomet (Warsaw, Indiana, USA) tibial trauma nail was used in LATN cases. In addition to locking screws, a distal syndesmotic screw was inserted to prevent fibular recoil. The frame was then removed. Patients in the MILN group were treated with a Precice (NuVasive, San Diego, CA, USA) magnetic motorized internal lengthening nail. Both distal and proximal fibular length stabilization screws (syndesmotic screws) were used. Blocking screws were used in some cases to prevent flexion deformity of the tibia. Vent holes were created at the osteotomy site. The IM canal was over-reamed by 2 mm with flexible reamers.
Weight-bearing as tolerated (WBAT) ambulation was allowed in the classic and LATN patients while in the frame. Once the frame was removed for classic patients (when ¾ cortices were united) weight-bearing was reduced to 50% for 2 weeks and then advanced based on repeat radiographs. When the LATN patients were converted to IM nail and the frame removed, they were restricted to 50% weight-bearing until 2/4 cortices were seen to be united at which point WBAT ambulation was allowed. The patients undergoing lengthening with the MILN were allowed partial weight-bearing as per the specifications of the nail used, 50lbs for 10.7 mm diameter nails and 70lbs for 12.5 mm diameter nails. WBAT was permitted when 2/4 cortices were united at the regenerate site. Patients were evaluated in the physician's office every two weeks during lengthening and then monthly during consolidation.
Physiotherapy started immediately postsurgery in the hospital. Knee and ankle range of motion exercises were reinforced. The patients were discharged with rehab instructions. Most patients performed joint motion exercises on their own. Some were referred to physical therapy usually based on the patient's need and ability to access outpatient rehabilitation.
Bone healing was determined in all groups using plain radiographs in the anteroposterior and lateral views as is the standard practice. For the MILN cohort, patient records were reviewed, and the date of consolidation stated in the chart was officially recorded for study purposes. In cases where the consolidation date was not explicitly mentioned, the radiographs were reviewed by one of the authors who was not the surgeon. When three of the four cortices of the tibia at the lengthening site were bridged with a solid white continuous cortical line the regenerate was declared united. For the classic and LATN groups, the date of union was stated in the records for all cases. This determination of this date in these cohorts was made in a similar fashion in previous studies. The time to healing was then determined by recording the number of days that passed between the osteotomy being performed and the regenerate being called united. The BHI was calculated by dividing the time to healing in months by the length of the regenerate in cm (months/cm). For the MILN cohort, the date of union was determined by this study group. For LATN and classic patients, the date of union was retrieved from the dataset.
Any change in the medial proximal tibial angle (MPTA) or posterior proximal tibial angle (PPTA) was interpreted as an angular deformity occurring as a result of the lengthening process. MPTA and PPTA were measured de novo for all patients in the MILN cohort by the lead author. Radiographic analysis for the MILN group was completed using Sectra Ortho Toolbox (Shelton, CT, USA). MPTA data for the classic and LATN cohorts were retrieved from previously published datasheets. The PPTA data were not available for the historical patients and most images predated our picture archiving and communication system making novel collection impossible. The PPTA was felt to be more meaningful in the MILN group as a loss of alignment in the sagittal plane after a proximal tibia osteotomy fixated with an IM nail is impossible to fix with the same nail and may be more common.
Clinical knee and ankle range of motion both preoperative and at the time of the latest follow-up were obtained from patient charts or dataset. Pre and postoperative functional outcome scores became a routine part of our practice just prior to the emergence of the Precice nail and were available for some of the MILN group patients. The Limb Deformity-Scoliosis Research Society (LD-SRS) score was used for functional assessment, which is a validated, modified version of the SRS score focusing on LD. These scores were not available for the classic and LATN patients.
There were 20 patients (32 tibiae) from the LATN group and 24 patients (34 tibiae) from the classic Ilizarov group chosen from an original dataset of 35 tibiae for each of the techniques. Three tibiae were eliminated from the LATN group and 1 from the classic Ilizarov group due to missing data points. In the internal lengthening group, 27 tibiae in 24 patients were included. This represented a sample from 25 consecutive cases, for which adequate follow-up for healing was available. One patient was excluded from data analysis because of mechanical failure of the nail to lengthen. This case was included as a complication.
Descriptive statistics were obtained on all variables. One-way analysis of variance with alpha set at 0.05 was used to compare age, length of follow-up, magnitude of lengthening, and BHI between the three groups. We used paired t-tests to compare the pre and postoperative joint ranges of motion, joint orientation angles, and functional outcome scores. There were occasional missing values. We completed all statistical analysis using the Analysis ToolPak in Microsoft Excel (Redmond, WA, USA).
| Results|| |
The BHI [Table 3] in the LATN group was the lowest among the three groups with a mean of 0.8 months/cm (range 0.4–1.3 months/cm). In the classic group, the mean BHI was 1.9 months/cm (range 1–4 months/cm), while in the MILN group, the mean was 1.5 months/cm (range 0.9–3 months/cm). The BHI was significantly lower (P < 0.001) in the LATN group compared to the MILN and classic groups. There was a significant difference in the amount of lengthening between the three groups which can affect the BHI [Table 2].
There was no statistically significant change in the MPTA postoperatively in any of the groups [Table 4]. The angles remained stable or were restored to near-normal over the course of treatment. This minimal change in coronal alignment indicates that the patients who underwent varus correction and lengthening all had mild deformity preoperative. In the MILN group, there was a statistically significant change in the PPTA after treatment; however, the mean change was only one degree, which is not clinically significant. The use of a posterior blocking screw did not seem to have any effect on PPTA. A posterior blocking screw was used in twelve of the 27 patients that underwent IM nailing with no notable difference in PPTA change when compared with the 15 patients where the screw was not utilized. The decision to use the screw was not random but instead was based on the space between the nail and the posterior cortex after nail insertion. If a screw would fit (>5mm of space) then it was inserted. There was one patient that sustained an intraoperative proximal propagation of the osteotomy that led to a significant flexion deformity of the proximal tibia after nailing. This outlier patient did not represent the MILN performance and was excluded from analysis but included in complications.
There were no significant changes in knee or ankle ranges of motion postoperatively among patients from the three groups [Table 5]. Some patients had contractures of the knee and/or ankle before treatment, however there was no change in the magnitude of these contractures. As post traumatic shortening due to ankle (including tibiotalocalcaneal and tibiocalcaneal) fusion was a common etiology, those patients were excluded from the ankle rough order of magnitude analysis. Of the 24 MILN patients, 9 had functional outcome data available for the analysis. Despite the small sample size, there was a significant change in the LD-SRS score after the surgery for these patients from a mean of 2.8 (range 1.6–4.3) before surgery to a mean of 4.3 (range 3.6–4.95) after the surgery (5 is the maximum score possible in this scoring system), with a value of P = 0.002.
There were no deep infections in the MILN group, compared to one in the LATN group and one in the classic group. There was one implant failure of a first generation (P1) Precice nail. This patient was excluded from the analysis as they elected not to proceed with further treatment. One patient had a residual deformity after lengthening that required a later corrective osteotomy. There were two cases of proximal interlocking screws that backed out during lengthening, one requiring replacement. One patient required a repeat osteotomy of the fibula due to premature consolidation. Eight tibiae in the MILN group were treated with percutaneous bone marrow aspirate concentrate (BMAC) injection into the regenerate. In some of these cases, the BMAC injection was done at the time of gastroc recession to speed the consolidation phase others were perceived to have slow consolidation, but these indications were not well documented. We recall that the same practice was done in the other groups, but documentation was too poor to comment on this making comparison for need for BMAC between groups impossible. There were no nonunions in any group, and no patient required open bone grafting. Ankle contractures were treated with gastrocsoleus recession as needed either prophylactically (12 limbs) or in response to failure to progress with physical therapy (5 limbs). LATN patients also underwent gastrocsoleus recession with 4/32 done prophylactically and 15/32 done for a post distraction ankle contracture. The classic group did not have gastrocsoleus recession well documented. There were no significant residual contractures in any of the groups.
| Discussion|| |
Although many studies have been published focusing on LATN, MILN or classic Ilizarov surgical outcomes, to our knowledge, no other study has tried to compare the clinical outcomes of these three different surgical procedures. In a retrospective study, 23 tibiae lengthened using the classic Ilizarov method were compared to 51 tibiae lengthened using the LON technique. In this study, there was found to be no difference in lengthening index or consolidation index between the two groups, however those in the Ilizarov group had a higher complication rate when compared to those in the LON group (1.0 vs. 0.47 per tibia). LATN was originally developed to decrease the amount of external fixation time required for limb lengthening. However successful, LATN still required external fixation for the lengthening phase. In a systematic review compiled by Xu, the author concluded that LATN is a superior method compared to the conventional Ilizarov method due to the significant mean differences in external fixation indices and consolidation indices between the two groups. The study demonstrated that the mean difference of the external fixation indices was −50.21 days/cm (P < 0.00001) between the LATN and Ilizarov groups, and the mean difference of the consolidation indices was −19.97 days/cm (P < 0.00001) between the two groups. In another study, 78 tibial lengthenings that were performed with longitudinal S-osteotomy and LATN technique was compared to 98 tibial lengthenings that were performed with the classic method (n = 176). The study demonstrated that there was no significant difference in the final gain in length between the two groups (8.49cm ± 1.71 to 9.25cm ± 2.22; P = 0.07); however, the consolidation index was significantly lower in the LATN group with a mean of 43.38 ± 5.35 days/cm when compared to the classic Ilizarov group with a mean of 76.19 ± 8.32 days/cm (P < 0.05). Newer methods using fully internal motorized lengthening nails have proven to be effective, but they have not been directly compared to all three known techniques. We reviewed our experience with a consecutive group of 24 patients (27 tibiae) using a Precice IM lengthening nail and compared this to two historical groups of patients: LATN and classic Ilizarov.
As a retrospective study, there are inherent limitations. Although the MILN group patients are a recent consecutive series, the historical comparison group includes patients for whom some data points were unavailable and not reproducible. However, these data points were taken from a previously published and well devised study. As the primary outcome measure of comparison was BHI, one major potential pitfall in comparing differing techniques is how to measure healing. The convention of ¾ cortices is subject to error. Another inherent error in this study is knowing exactly when bridging occurs; since patients are seen monthly for radiographs, healing could have occurred before the date of visit. The anterior cortex of the tibia heals more slowly than the other cortices as a result of its poorer soft-tissue envelope, however, we did not document the consolidation of the anterior cortex in this study as it was not recorded in the older datasets for comparison. The location of the tibial osteotomy varied in the cohorts. The distance from the knee joint to the osteotomy was well documented for MILN patients with an average of 12.4 cm. Osteotomy distance for LATN was typically 10 cm although this was not measured. The inconsistency in the osteotomy location between techniques may have affected the BHI. The use of BMAC was well documented in the MILN patients but not documented for the other groups and confuses the comparison of BHI between techniques. The practice of injecting BMAC is not new. If patients need to return to the Operating Room (OR) to treat an obstacle, then we take advantage of the opportunity, and BMAC is often injected to stimulate healing. This was done in all cohorts but poorly documented. If we assume that only the MILN patients received BMAC, and that the injection truly improved healing, then perhaps MILN unites the slowest of all methods. All techniques have a learning curve that requires mastery. The LATN and MILN cohorts include all patients that underwent this technique in the tibia and therefore reflect the learning curve cases. The Classic method patients were collected well after the learning curve for TSF. The effect of this is unknown. One of the lessons learned from MILN was importance of blocking screws to prevent flexion and valgus deformity during distraction which took an estimated 10 cases to appreciate.
The BHI for LATN was significantly lower than that after MILN or classic Ilizarov lengthening. Improved healing time with LATN is thought to be a result of reaming though the regenerate, as opposed to LON where the bone is reamed before distraction and the reaming benefits to regenerate formation are not realized. BHI is affected by the length of the distraction gap with longer gaps having a lower BHI.
The LATN group underwent a greater average lengthening compared to the MILN and classic groups which were significant. This is a result of a disproportionate number of stature lengthenings done using the LATN method compared with the other two methods. In the era of Precice, there has been a change in practice to MILN of the femur for stature lengthening, and hence, the MILN was not used for this indication as frequently in the tibia. The BHI for MILN was lower than that for classic Ilizarov but not significantly. This conclusion may also be affected by the use of BMAC injection in the MILN group which would ostensibly reduce the BHI artificially making the comparison less reliable.
In our series, we measured no clinically significant change in the PPTA or the MTPA after lengthening with the MILN and no difference in the MPTA change between each cohort. The average osteotomy distance from the joint line in the MILN group was approximately 124 mm (the target was 100 mm from the joint line for simple lengthening and the apex of deformity, for malunions). This is still in the metadiaphyseal region, and hence, there is concern for loss of alignment in both the sagittal and coronal planes. However, other than posterior propagation of an osteotomy leading to some loss of alignment in one case, malalignment was uncommon. One must keep in mind that the average lengthening was low at 4.1 cm which creates less deformity. Longer lengthenings may have produced more valgus and procurvatum deformity. Blocking screws in the sagittal and coronal planes were used in most cases, however if the osteotomy ended up near the isthmus of the tibia, they were not always required. The use of blocking screws was strategic, and if the cortex contacted the IM nail they were not used. As such we cannot compare results with and without blocking screws. As with nailing of proximal third tibia fractures for trauma, blocking screws are an excellent tool to help maintain reduction of the bone when the canal is significantly wider than the nail. Although the basic principles are the same, the “reverse rule of thumbs” is helpful in determining where to place the blocking screws, particularly for coronal plane correction.,
Knee and ankle range of motion were not affected by any of these techniques when gastrocsoleus recession was employed as needed. Functional outcomes improved the in sub-group of MILN patients where LD-SRS score data were available. The ability to return to active sports after large LATN, LON, and intramedullary skeletal kinetic distractor tibial lengthenings has been limited, but this has not been studied after Precice lengthening. The LD-SRS is not a sensitive measurement of patients' return to sports and highlights the need for further studies on functional results after tibial Precice lengthening.
| Conclusion|| |
All three techniques for tibia lengthening have a place in the treatment of limb deformity and limb length discrepancy. A motorized internal lengthening nail is an effective tool for the treatment of limb length discrepancy through the tibia with improved patient experience over external fixation. Some bony deformity can be corrected acutely with the nail, but it is not known how much correction will be tolerated by the neurovascular structures or how a large acute correction will affect regenerate formation. LATN allows for more flexibility with larger lengthenings (>8 cm) and faster healing,, but it does require an extra surgical procedure for nail insertion. Deformity is able to be corrected gradually provided that a relatively straight bone is achievable by the end of distraction for nail insertion. LATN is an excellent technique for patients with healing challenges including older patients. Classic Ilizarov treatment still has its place in the treatment algorithm for tibial lengthenings. It can be used in skeletally immature patients and as well as for distal deformities not amenable to nailing. Complex and large deformities can be corrected, multilevel osteotomies created, joint scan be spanned to prevent subluxation, and a patent IM canal is not required. In addition, as there is no retained hardware after removal it is an excellent option for patients in whom infection is a concern, and in those with a poor soft-tissue envelope. LATN had the fastest BHI, malunion was rare with minimal change in MPTA and a clinically irrelevant change in PPTA. Joint range of motion was minimally affected with the selective use of gastrosoleus recession. In our series there were no nonunions, persistent joint contractures or significant deep infections. Applied appropriately all three techniques are effective and lead to healing without any significant coronal plane deformity. Future investigations on this topic will need to control for the many variables that have limited this study's ability to make firm conclusions which will require either a prospective study or a prospective collection of data with the intent for later retrospective analysis.
Financial support and sponsorship
Conflicts of interest
Dr. Austin T. Fragomen is a consultant for Depuy Synthes, NuVasive, and Smith and Nephew. Dr. S Robert Rozbruch is a consultant for NuVasive, Smith and Nephew, Stryker, and Orthospin. All other contributing authors declare no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]