A comparative study of bone union and nonunion during distraction osteogenesis.

BACKGROUND: The clinical characteristics of bone nonunion during distraction osteogenesis (DO) were rarely discussed. This study was employed to specify the difference between bone union and nonunion during DO. METHODS: The patients with bone lengthening were recruited in our study. The bone union cases indicated the ones that remove the external fixator successfully, whereas the bone nonunion represented the bridging callus did not appear even after 9 months (an absence of bridging callus for at least three out of four cortices on plain radiographs) that needs autogenous bone transplantation. The differences in the pixel value ratio (PVR) growth of regenerated callus, lengthening index (LI), healing index (HI), external fixation index (EFI) and blood biochemical indexes between bone union and nonunion were analyzed. RESULTS: A total of 8 bone nonunion and 27 bone union subjects were included in this study. The PVR growth in bone nonunion was significantly lower than that in bone union (0.19 ± 0.06 vs. 0.32 ± 0.16, P = 0.048). Interestingly, the HI and EFI in bone nonunion was significantly higher than that in bone union (62.0 ± 31.4 vs. 37.0 ± 27.4, P = 0.036; 75.0 ± 30.9 vs. 49.9 ± 16.1, P = 0.006). However, no significant difference with regard to LI was identified (0.76 ± 0.52 vs. 0.77 ± 0.32, P = 0.976). Moreover, the circulating level of urea and lymphocyte count in bone union was significantly lower than that in bone nonunion (4.31 ± 1.05 vs. 5.17 ± 1.06, P = 0.049; 2.08 ± 0.67 vs. 2.73 ± 0.54, P = 0.018). On the contrary, the circulating level of magnesium in bone union was significantly higher than that in bone nonunion (0.87 ± 0.07 vs. 0.80 ± 0.07, P = 0.014). CONCLUSION: Compared to the bone union, the PVR growth was significantly lower, whereas the HI and EFI was significantly higher in the bone nonunion. Moreover, the circulating level of urea, magnesium and lymphocyte count was also different between these two. Therefore, the PVR, HI and EFI seems to be reliable and sensitive indicators to reflect the bone nonunion during DO, which might be considered in bone lengthening. Further prospective studies are still needed to elaborate the concerned issues.

A modified pixel value ratio based on contralateral normal bone: a novel reliable indicator for distraction osteogenesis.

BACKGROUND: The traditional pixel value ratio (tPVR) is subject to disuse osteopenia of the adjacent bone in distraction osteogenesis (DO). Therefore, a modified PVR (mPVR) based on the contralateral normal bone was developed and validated to address this issue. METHODS: A total of 79 bone lengthening subjects were recruited in this retrospective study. The difference between the mPVR and tPVR of early callus was identified in the first three months after osteotomy. Moreover, we further investigated the relationship between mPVR and healing index (HI), lengthening index (LI) and external fixator index (EFI). Finally, the potential influencing factors for mPVR of the early callus were analyzed. RESULTS: The mPVR was significantly lower than the tPVR in the first three months after osteotomy, and the difference gradually increased. Interestingly, the mPVR of the early callus in the first two months was negatively correlated with the HI, LI and EFI. Moreover, the age, lengthening site, total bilirubin and mean hemoglobin content were associated with the mPVR of early callus during DO. CONCLUSION: The mPVR based on contralateral normal bone is a novel reliable indicator for DO, which may be helpful for the clinical management of DO. However, the findings of this study need to be confirmed further by larger prospective research.

The early posterior cortex pixel value ratio: a novel reliable indicator for distraction osteogenesis.

Aims: We aimed to explore the associations of the early PVR in four cortices with Healing Index (HI), Lengthening Index (LI), and External Fixator Index (EFI) in the bone union and non-union groups. Methods: A total of 52 patients, including 39 bone union and 13 bone non-union subjects, were recruited in this study. The general characteristics and PVR in four cortices in each group were explored. Afterward, the early PVR in four cortices, including medial, lateral, anterior, and posterior sides, were compared. Finally, the associations of the early PVR in four cortices with HI, LI, and EFI were also investigated. Results: The general characteristics of these patients were consistent, except for HI (31.54 ± 12.24 vs. 45.08 ± 27.10, P = 0.018) and EFI (57.63 ± 18.15 vs. 71.29 ± 24.60, P = 0.046). The growth of regenerated callus was asymmetrical in the bone union group (the posterior PVR seems to grow faster), whereas no statistical difference was obtained in the bone non-union group. Furthermore, the posterior PVR in the bone union group was significantly higher than that in the bone non-union group (the first month: 0.96 ± 0.17 vs. 0.86 ± 0.06, p = 0.047; the second month: 0.98 ± 0.14 vs. 0.89 ± 0.09, p = 0.041; the third month: 1.00 ± 0.12 vs. 0.92 ± 0.09, p = 0.039). Most importantly, the posterior PVR was inversely associated with HI, LI, and EFI (the first month: r = -0.343, p = 0.041; r = -0.346, p = 0.042; r = -0.352, p = 0.041; the second month: r = -0.459, p = 0.004; r = -0.277, p = 0.101; r = -0.511, p = 0.002; the third month: r = -0.479, p = 0.003; r = -0.398, p = 0.018; r = -0.551, p = 0.001) in the bone union group, respectively. However, this finding was lost in the bone non-union group. Conclusion: The early posterior cortex PVR seems to grow faster than the medial, lateral, and anterior sides in the bone union group, which represents an asymmetrical development pattern. Moreover, the posterior cortex PVR was negatively associated with HI, LI, and EFI, respectively. The posterior cortex PVR may be a novel and reliable detection index in the process of DO.

Early Weight-bearing Accelerates Regenerate Bone Mineralisation: A Pilot Study Comparing Two Post-operative Weight-bearing Protocols Following Intramedullary Limb Lengthening Using the Pixel Value Ratio.

Introduction: Limb lengthening is increasingly accomplished by internal lengthening nails. Previous versions of the magnetic lengthening nails made from titanium alloy allowed limited weight-bearing. In contrast, the newer nails made of stainless steel allow increased weight-bearing. An objective comparison of the rate of healing of the regenerate bone based on the weight-bearing capabilities of these two types of lengthening nails has not been evaluated. The hypothesis for the study is that earlier commencement of full weight-bearing in patients treated with the stainless steel STRYDE® nail will lead to faster healing of the regenerate bone during intramedullary limb lengthening compared with those treated with the titanium PRECICE® nail. Materials and methods: Thirty patients, divided into two groups of 15 each, underwent antegrade intramedullary lengthening of the femur using a magnetic lengthening nail between May 2017 and November 2020. The pixel value ratio (PVR) obtained from serial digital radiographs was used to quantitatively determine the regenerate bone's mineralisation rate. We compared the rate of healing of the regenerate bone in both groups of patients using the PVR. Results: Patients treated with the STRYDE® nail achieved unassisted full weight-bearing significantly earlier than patients treated with the PRECICE® nail (12 weeks vs 17 weeks for STRYDE® and PRECICE® nail-lengthened patients, respectively, p = 0.003). There was no difference in the PVR between both groups of patients at the time of full weight-bearing (p = 0.0857). However, patients treated with the STRYDE® nail attained a PVR of 1 significantly earlier than those treated with the PRECICE® nail (0.0317). Conclusion: The STRYDE® nail provides an earlier return of function and full weight-bearing compared with the PRECICE® lengthening nail. Earlier commencement of weight-bearing ambulation leads to more rapid mineralisation of the regenerate bone in patients undergoing intramedullary limb lengthening. How to cite this article: Bafor A, Duncan ME, Iobst CA, et al. Early Weight-bearing Accelerates Regenerate Bone Mineralisation: A Pilot Study Comparing Two Post-operative Weight-bearing Protocols Following Intramedullary Limb Lengthening Using the Pixel Value Ratio. Strategies Trauma Limb Reconstr 2022;17(3):148-152.

Early Pixel Value Ratios to Assess Bone Healing During Distraction Osteogenesis.

Background: Distraction osteogenesis (DO) is an approach for bone lengthening and reconstruction. The pixel value ratio (PVR), an indicator calculated from X-ray images, is reported to assess the final timing for the external fixator removal. However, the early PVR and its potential influencing factors and the relationship between the early PVR and clinical outcomes are rarely discussed. Therefore, this study was employed to address these issues. Methods: A total of 125 patients with bone lengthening were investigated retrospectively. The early PVR of regenerated bone was monitored in the first 3 months after osteotomy. The potential effect of sex, chronological age, BMI, lengthening site, and involvement of internal fixation during the consolidation period was analyzed. Moreover, the associations of the healing index (HI) and lengthening index (LI) with early PVR were also investigated. Results: The early PVRs were 0.78 ± 0.10, 0.87 ± 0.06, and 0.93 ± 0.06 in the first 3 months after osteotomy, respectively. Moreover, the PVR in juvenile was significantly higher than that in adults in the first 3 months after osteotomy (0.80 ± 0.09 vs. 0.74 ± 0.10; p = 0.008), (0.89 ± 0.06 vs. 0.83 ± 0.06; p = 0.018), and (0.94 ± 0.05 vs. 0.87 ± 0.05; p = 0.003). In addition, the PVR in males was significantly higher than that in females in the first month after osteotomy (0.80 ± 0.09 vs. 0.76 ± 0.10; p = 0.015), and the PVR in femur site was significantly higher than that in the tibia site in the second and third months after osteotomy (0.88 ± 0.07 vs. 0.87 ± 0.06; p = 0.015) and (0.93 ± 0.06 vs. 0.92 ± 0.06, p = 0.037). However, the BMI and involvement of the internal fixator during the consolidation period seem to not influence the early PVR of regenerated callus during DO. Interestingly, the early PVR seems to be moderately inversely associated with HI (mean = 44.98 ± 49.44, r = -0.211, and p = 0.029) and LI (mean = 0.78 ± 0.77, r = -0.210, and p = 0.029), respectively. Conclusion: The early PVR is gradually increasing in the first 3 months after osteotomy, which may be significantly influenced by chronological age, sex, and the lengthening site. Moreover, the early PVR of callus may reflect the potential clinical outcome for DO. Our results may be beneficial to the clinical management of the subjects with bone lengthening.

Use of the Pixel Value Ratio Following Intramedullary Limb Lengthening: Uncomplicated Full Weight-bearing at Lower Threshold Values.

Aims: The pixel value ratio (PVR) can be used to assess regenerate consolidation after lengthening and guide advice for full weight-bearing (FWB). This study aimed to analyse the PVR in adults having femoral lengthening, the time to FWB and compare findings with the reported values in the literature. Materials and methods: A retrospective database review identified 100 eligible patients who underwent lengthening using the PRECICE nail (68 antegrade and 32 retrograde). The PVR was calculated in each cortex on plain radiographs at every visit. The ratio between the regenerate and an average from the adjacent normal bone was calculated and plotted against the clinical decision to allow FWB. Results: Eighty-seven patients (58 men and 29 women) were assessed; eleven had bilateral lengthening and two patients underwent lengthening twice. The median age was 30.5 years. The underlying cause of shortening was post-traumatic in 46%, with the remaining due to a wide variety of causes, including congenital 16%, syndromic 12% and other causes. The median lengthening achieved was 45 mm, at a median of 57.5 days. The PVR increased with each visit (p <0.0001). FWB was allowed at a median of 42 days after the last day of lengthening, with PVR values of 0.83, 0.84, 0.93 and 0.84 for the anterior, posterior, medial and lateral cortex noted, respectively (average 0.85). There were no implant failures, shortening or regenerate fractures. No differences were detected between antegrade and retrograde nails or with lengthening greater or less than 45 mm. One surgeon allowed earlier FWB at median 31 days with no nail failures. Conclusion: PVR is a valuable tool that quantifies regenerate maturity and provides objectivity in deciding when to allow FWB after intramedullary lengthening with the PRECICE nail. FWB was permitted at an earlier time point, corresponding with lower PVR values than have been reported in the literature and with no mechanical failure or regenerate deformation. How to cite this article: Elsheikh AA, Wright J, Stoddart MT, et al. Use of the Pixel Value Ratio Following Intramedullary Limb Lengthening: Uncomplicated Full Weight-bearing at Lower Threshold Values. Strategies Trauma Limb Reconstr 2022;17(1):14-18.

Bone reconstruction: Subjective evaluation and objective analysis based on conventional digital X-rays - a retrospective evaluation.

BACKGROUND: Various approaches have been used to evaluate callus stiffness in distraction osteogenesis. This assessment becomes even more critical as inadequate corticalization and premature removal of the frame lead to bending, refracture, and loss of length. This study aimed to verify the objective Pixel Value Ratio (PVR) and define an evaluation scheme to assess callus tissue development during internal and external bone lengthening. HYPOTHESIS: There are no differences between subjective parameters and objective evaluation for external and internal bone lengthening. PATIENTS AND METHODS: We included 24 patients in this retrospective study, treated by distraction osteogenesis of the lower limb. Ten patients were treated with external ring fixators and 14 with intramedullary lengthening devices. The minimum distraction distance was 3cm. Callus tissue was evaluated with the PVR, using digital X-rays during and after treatment. We combined this method with subjective evaluation parameters, including the continuity, signal intensity, and the regeneration tissue's homogeneity, presented in the X-ray Evaluation System for Distraction Osteogenesis (XESDO). RESULTS: The subjective evaluation showed an increase of continuity and signal-intensity between 4th postoperative weeks and complete healing with significant differences between the external and internal groups for homogeneity only after four weeks and for all parameters at 3C (p<0.05). The PVR showed an increase during consolidation with values between 0.7 and 1.0 for both groups with almost perfect interobserver agreement. Significant lower values were found in the anterior tibial cases. CONCLUSION: PVR appears to be a practical tool for radiological evaluation of callus tissue development. In combination with the newly introduced XESDO and the surgeon's experience, these methods can be helpful for decisions during all phases of distraction osteogenesis. It is important for adapting alignment or distraction-rate, as various potential complications can be detected early. However, further studies are necessary to assess the image-based determination of callus tissue stability. LEVEL OF EVIDENCE: III; cohort study.

Evaluating the Utility of the Pixel Value Ratio in the Determination of Time to Full Weight-bearing in Patients Undergoing Intramedullary Limb Lengthening.

INTRODUCTION: Limb lengthening using intramedullary nails is an increasingly popular method of achieving limb length equalisation. Currently, the decision regarding when to commence full weight-bearing (FWB) remains largely subjective. Objective criteria for determining the proper timing of FWB would be helpful to limb lengthening surgeons. This study examines using the pixel value ratio (PVR) as an objective method to determine the time to FWB for patients being lengthened with an intramedullary nail. MATERIALS AND METHODS: A retrospective chart review of 42 patients who underwent unilateral lengthening of the femur was undertaken. The PVR of all four cortices of the regenerate bone was monitored throughout the distraction and consolidation stages to determine the ratio at the time of FWB. RESULTS: Clinically and radiologically determined FWB was achieved at a mean time of 125.7 ± 30.1 days from surgery. The mean PVR at the time of FWB was 0.94. The medial cortex healed fastest with a mean PVR of 0.96, while the posterior cortex healed slowest with a mean PVR of 0.92. CONCLUSION: The PVR is a quick and reliable method to objectively assess the state of healing of the regenerate bone during distraction osteogenesis. We observed that there were no adverse effects when subjects commenced FWB when three out of the four cortices had a PVR of at least 0.93. HOW TO CITE THIS ARTICLE: Bafor A, Duncan ME, Iobst CA. Evaluating the Utility of the Pixel Value Ratio in the Determination of Time to Full Weight-bearing in Patients Undergoing Intramedullary Limb Lengthening. Strategies Trauma Limb Reconstr 2020;15(2):74-78.