Technical considerations and early results of magnetic compressive intramedullary nailing for tibial and femoral shaft non-unions: a case series

Background: Several treatment approaches are now considered to manage tibial and femoral shaft nonunion after primary surgeries. Double-locking plates with channel bone grafting technology are treatments that surgeons could choose. We aimed to describe our experiences in evaluating the union of bone for these patients after using double-locking plates with channel bone grafting with serial examinations and radiologic studies. Methods: This case study was conducted on 33 patients consisting of 20 femoral nonunion and 13 tibial nonunion cases. They underwent double plate fixation with bone grafting at Sina Hospital, Tehran, Iran, from 2015 to 2020. They were monitored for an average of 60 months after surgery Results: Union was achieved in all the patients in a mean of 10.03 months (range: 8-18 months). During patients’ follow-up, no plate and screw breakage, device loosening, deformity, and infection were seen. No additional surgery was needed for any of our patients. Conclusion: There are various treatment options for nonunion of long bones. This study described the double plating approach for treating femoral and tibial shaft nonunion. The technique of double plate fixation and bone grafting had reasonable union rates in long bone nonunion. The present case series analysis also shows that it is more beneficial to manipulate this promising method for long bone nonunion whenever possible.

Long bone non-unions may lead to recurrent surgical procedures and in-hospital stays. Thus, restrictions of the health-related quality of life and of socioeconomic parameters might be expected. Knowledge of the impact on several parameters of professional life is sparse. Therefore, we analyzed the outcome in patients following non-unions of the tibial and femoral shaft after fracture compared to patients with uneventful healing.Material and Methodology:51 patients following non-unions of the the femoral (FNU) or tibial shaft (TNU) were compared to 51 patients (groups FH and TH) with uneventful fracture healing. Physical and mental health was assessed using the Short-Form Health Survey (SF-12), Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES). We also analyzed employment status and the usage of medical aids.Results:Scores of the SF-12 physical and psychological were lower in group TNU compared to group TH, the score of SF-12 physical but not psychological was significantly lower in group FNU compared to FH. Compared to uneventful healing, a significantly more frequent usage of medical aids was found in both non-union groups. A higher incidence of early retirement and unemployment was found in group FNU but not in group TNU.Conclusions:There is a profound influence on the quality of life following femoral or tibial non-unions after trauma. Compared to patients with uneventful fracture healing, patients with tibial and even more so femoral non-union show worse scores of the SF-12. Medical aids are frequently used following both, femoral and tibial non-unions. Not tibial, but femoral non-unions frequently lead to severe restrictions in professional life such as early retirement and unemployment.

Background: Tibial and femoral nonunion is not unusual after intramedullary fixation and might lead to multiple surgical procedures and long-term disabilities. Different surgical techniques have been described for management of lower limb long bone nonunion primarily treated with intramedullary nailing. Despite the use of various procedures, the success rate of most of them are suboptimal, increases the risk of related complications and costs. Objectives: Augmented plating concomitant with autologous bone grafting technique make it possible to improve healing in a single operation. Methods: In this study, 19 patients with lower limb long bone nonunion were primarily fixed with intramedullary nails, were treated with augmented plating and autologous bone grafting and followed for one year. Results: The union rate was 94.7% with a mean union time of 4.75 months, 18 patients healed completely with solid union and only one case of femoral shaft nonunion remained. Infection and other surgical-related complications were not detected. After one year follow up, Visual Analog Scale was 31 ± 18.8, and decrement in active knee range of motion was more than 20% compared with opposite side in 47.4% of the patients. Conclusion: According to the results, the single stage augmented plating with locking plates combined with autologous bone grafting can be used as a useful method in treatment of femoral or tibial nonunion.

BackgroundSeptic and aseptic nonunion require different therapeutic strategies. However, differential diagnosis is challenging, as low-grade infections and biofilm-bound bacteria often remain undetected. Therefore, the examination of biofilm on implants by sonication and the evaluation of its value for differentiating between femoral or tibial shaft septic and aseptic nonunion in comparison to tissue culture and histopathology was the focus of this study.Materials and methodsOsteosynthesis material for sonication and tissue samples for long-term culture and histopathologic examination from 53 patients with aseptic nonunion, 42 with septic nonunion and 32 with regular healed fractures were obtained during surgery. Sonication fluid was concentrated by membrane filtration and colony-forming units (CFU) were quantified after aerobic and anaerobic incubation. CFU cut-off values for differentiating between septic and aseptic nonunion or regular healers were determined by receiver operating characteristic analysis. The performances of the different diagnostic methods were calculated using cross-tabulation.ResultsThe cut-off value for differentiating between septic and aseptic nonunion was ≥ 13.6 CFU/10 ml sonication fluid. With a sensitivity of 52% and a specificity of 93%, the diagnostic performance of membrane filtration was lower than that of tissue culture (69%, 96%) but higher than that of histopathology (14%, 87%). Considering two criteria for infection diagnosis, the sensitivity was similar for one tissue culture with the same pathogen in broth-cultured sonication fluid and two positive tissue cultures (55%). The combination of tissue culture and membrane-filtrated sonication fluid had a sensitivity of 50%, which increased up to 62% when using a lower CFU cut-off determined from regular healers. Furthermore, membrane filtration demonstrated a significantly higher polymicrobial detection rate compared to tissue culture and sonication fluid broth culture.ConclusionsOur findings support a multimodal approach for the differential diagnosis of nonunion, with sonication demonstrating substantial usefulness.Level of Evidence: Level 2Trial registration DRKS00014657 (date of registration: 2018/04/26)

To determine the outcome of initial external fixation and then conversion to intramedullary nailing in patients having open fracture of shaft of femur or tibia. Descriptive study. Combined Military Hospital (CMH), Quetta, from July 2002 to July 2004. Out of 59 patients with fractures of shaft of tibia and femur, 16 were selected for the study who had open fractures in Gustilio type I, II and III. They were initially managed with external fixators and later on converted to planned locked intramedullary nailing. Interlocking nailing was done on routine operation list in the third week after Ex Fix (external fixator) was removed. Record of patients was kept, and was statistically analyzed on SPSS. Out of the 16 patients, 12 had fractures of femur and 4 had fractures of tibia. Male to female ratio was 7:1. Mean duration of external fixation was 6.22 weeks. Six patients underwent closed interlocking nailing and 10 patients with open method. Fifteen fractures (94%) united within 6 months, and one fracture had delayed union. Two patients had superficial wound infection and one patient had deep infection. Immediate external fixation followed by early closed interlocking nailing is a safe and effective treatment for open fractures of shaft of femur and tibia.

The diaphyseal aseptic tibial nonunions after failed previous treatment options managed with the reamed intramedullary locking nail

Objective To retrospectively compare the outcomes between exchange reamed intramedullary nailing (ERN) and augmentation compression plating (ACP) combined with autogenous bone grafting in treatment of femoral shaft nonunion after intramedullary nailing. Methods A multicentre retrospective study was performed for 178 patients (180 sides) with femoral shaft nonunion after intrame-dullary nailing. Eighty-six (87 sides) out of the 178 patients underwent ERN (Group A) consisting of nonisthmal nonunions in 42 sides (48%) and isthmal nonunions in 45 sides (52%). The remaining 92 patients (93 sides) underwent ACP combined with autogenous bone grafting (Group B)consisting of nonisthmal nonunions in 46 sides (49%) and isthmal nonunions in 47 sides (51%). Comparative study was made on operation time, intraoperative blood loss, time to union, union rate, postoperative draining volume and complication rate. Results Mean follow-up was 4.1 years (range, 1-7.1 years). Union rate was 86% for Group A and 100% for Group B (OR=3. 28, 95%CI 0.8-14.0). In Group A re-nonunion was seen in 12 sides including nonisthmal nonunions in 10 sides (83%) and isthmal nonunion with cortical bone defect>3 cm in 2 sides (17%). Group A reported higher values in time to union, intraoperative blood loss as well as complication rate and lower healing rate over Group B(P 0.05). However, for nonisthmal nonunions, operation time was (127.3±21.7)min in Group A versus (89.9±14.1)min in Group B (P<0.05). Conclusions In contrast, ACP combined with autogenous bone grafting results in shorter time to union and higher bone union rate during the treatment of femoral shaft nonunion after failed intramedullary nailing. Especially for nonisthmal or isthmal femoral shaft nonunions with larger bone defect, ACP combined with autogenous bone grafting brings relatively more advantages. Key words: Femoral fractures; Fractures, ununited; Intramedullary nailing

Purpose Although exchange nailing is a standard method of treating femoral shaft nonunion, various rates of healing, ranging from 72% to 100%, have been reported. The purpose of this study was to evaluate the efficacy of exchange nailing in femoral shaft nonunion. Methods We retrospectively reviewed 30 cases of aseptic femoral shaft nonunion after intramedullary nailing. The mean postsurgical period of nonunion was 66.8 weeks. A nail at least 2 mm larger in diameter was selected to replace the previous nail after reaming. Distal fixation was performed using at least two interlocking screws. The success of the procedure was determined by the finding of union on simple radiographs. Possible reasons for failure were analyzed, including the location of nonunion, the type of nonunion, and the number of screws used for distal fixation. Results Of the 30 cases, 27 achieved primary healing with the technique of exchange nailing. The average time to achieve union was 23.1 weeks (range, 13.7–36.9 weeks). The three failures involved nonunion at the isthmic level (three of 15 cases), not at the infraisthmic level (zero of 15 cases). Of eight cases of oligotrophic nonunion, two (25%) failed to heal, and of 22 cases of hypertrophic nonunion, one (4.5%) failed to heal. Of 11 cases involving two screws at the distal fixation, two (18.2%) failed to heal, and of 19 cases involving three or more screws, one (5.3%) failed to heal. None of these findings was statistically significant. Conclusions Exchange nailing may enable successful healing in cases of aseptic nonunion of the femoral shaft. Although nonunion at the isthmic level, oligotrophic nonunion, and weaker distal fixation seemed to be associated with a higher chance of failure, further study is needed to confirm those findings. Keywords: Femoral shaft nonunion; Exchange nailing; Risk factors; Distal interlocking

BackgroundSurgical revision concepts for the treatment of aseptic humeral, femoral, and tibial diaphyseal nonunion were evaluated. It was analyzed if the range of time to bone healing was shorter, and if clinical and radiological long-term outcome was better following application of additional recombinant human Bone Morphogenetic Protein-7 (rhBMP-7) compared to no additional rhBMP-7 use.MethodsIn a retrospective comparative study between 06/2006 and 05/2013, 112 patients diagnosed with aseptic diaphyseal humerus (22 patients), femur (41 patients), and tibia (49 patients) nonunion were treated using internal fixation and bone graft augmentation. For additional stimulation of bone healing, growth factor rhBMP-7 was locally administered in 62 out of 112 patients. Follow-up studies including clinical and radiological assessment were performed at regular intervals as well as after at least one year following nonunion surgery.ResultsOne hundred and two out of 112 (humerus: 19, femur: 37, tibia: 47) nonunion healed within 12 months after revision surgery without any significant differences between the cohort groups. According to the DASH outcome measure for the humerus (p = 0.679), LEFS for the femur (p = 0.251) and the tibia (p = 0.946) as well as to the SF-12 for all entities, no significant differences between the treatment groups were found.ConclusionsAseptic diaphyseal nonunion in humerus, femur, and tibia healed irrespectively of additional rhBMP-7 application. Moreover, the results of this study suggest that successful nonunion healing can be linked to precise surgical concepts using radical removal of nonunion tissue, stable fixation and restoration of axis, length and torsion, rather than to the additional use of signaling proteins.Trial registrationThis clinical trial was conducted according to ICMJE guidelines as well as to the approval of the National Medical Board (Ethics Committee of the Bavarian State Chamber of Physicians; TRN: 2016-104) and has been retrospectively registered with the German Clinical Trails Register (TRN: DRKS00012652).

Exchange nailing is widely used for the management of aseptic femoral and tibial non-union. Compressive forces markedly reduce strain, increasing rate and incidence of union. Additional compressive forces can be applied to the non-union site by using the design features of some modern nailing systems. This study hypothesises that the use of additional compression in exchange nailing results in faster time to union. All femoral and tibial shaft non-unions were identified over a 4-year period between 2014-2018. Intraoperative compression during exchange nailing was either applied or not applied with a dedicated active compression device through the intramedullary nail. An initial 'radiographic union score for tibia' (RUST) score was calculated from preoperative lateral and AP radiographs and compared with the postoperative radiographs at 6-8weeks. Healing was defined as bridging callus on at least three cortices (RUST > 10). A total of 119 patients were identified. Following application of exclusion criteria, we analysed data for 19 patients, 10 undergoing exchange nailing with intraoperative compression and 9 without. The pre-exchange RUST score was comparable between the compressed group and standard exchange group with mean of 7.11 versus 7.5 (p = 0.636). At 6-8weeks post-op, there was a significant difference between the median RUST score in the compressed group vs standard exchange group, 11 compared to 8.39 (p = 0.001). Our study shows that time to union was accelerated when additional compression was applied to exchange nailing, resulting in reduced follow-up visits and number of radiographs required.

Treatment algorithms for fracture nonunion depend on the presence or absence of bacterial infection. However, it is often impossible to identify infection preoperatively. While some infections may present with clinical signs of infection, low-grade infections lack infection signs and have a clinical presentation similar to aseptic nonunion. The clinical relevance of low-grade infection in nonunion is not entirely clear. Therefore, the aim of this study was to evaluate the role of low-grade infection in the development and management of lower extremity nonunion. A prospective multicenter clinical study enrolled patients with femoral or tibial shaft nonunion and regular healed fractures, scheduled for nonunion revision and routine implant removal, respectively. Preoperatively, serum markers including C-reactive protein (CRP), leukocytes, and procalcitonin were determined, clinical infection signs were recorded, and a suspected septic or aseptic diagnosis was made prior to surgery and further diagnostics. Tissue samples were collected for microbiology and histopathology, and osteosynthesis material for sonication. Nonunion patients were followed for twelve months, during which the definitive diagnosis of "septic" or "aseptic" nonunion was made according to diagnostic criteria for fracture-related infection. One hundred and ten patients with nonunion and 34 patients with regular healed fractures were included. Sixty-two nonunion patients were diagnosed as aseptic, 22 with expected and confirmed infection, and 23 with unexpected low-grade infection. Three patients had an unclear diagnosis. Low-grade infection was detected in 28 % of presumed aseptic nonunion patients. Sensitivity and specificity for the suspected diagnosis were 49 % and 95 %, respectively. The suspected diagnosis had a significant impact on revision strategy. All medians of the preoperative blood values were within the reference ranges except for CRP, which was slightly elevated in the expected and confirmed infected nonunion group. Expected and confirmed septic nonunion and unexpected low-grade infected nonunion demonstrated a similar bacterial spectrum. While 10 % of patients with aseptic nonunion required follow-up surgeries, re-operation rates were higher in patients with low-grade infection and expected and confirmed infection at 30 % and 64 %, respectively. Patients with low-grade infections were treated less frequently with systemic antibiotics and for a shorter duration than patients with expected and confirmed infections, with no significant difference in healing rate which was 83 % in low-grade and 62 % in expected and confirmed infections. The healing rate of aseptic nonunion was 90 %. A limitation of this study is the limited number of tissue samples for microbiological and histopathological diagnostics in the suspected aseptic nonunion cohort, which may have led to an underestimation of the low-grade infection rate. Our findings suggest that unexpected low-grade infection is frequently associated with nonunion. While expected and confirmed infected nonunion differs significantly from aseptic nonunion, low-grade infected nonunion is very similar to aseptic nonunion, except for intraoperative bacterial detection. In addition to antibiotic therapy, surgical nonunion revision with implant exchange and debridement appears to be highly effective in achieving consolidation of low-grade infected nonunion.

ABSTRACTTreatment guidelines for fracture nonunion differ based on the presence or absence of infection. Low‐grade infections without preoperative clinical signs of infection are difficult to distinguish from aseptic cases. Membrane filtration of sonication fluid (MF) has been shown to be a useful method for identifying septic nonunion. Therefore, the aim of this study was to evaluate the diagnostic value of MF in differentiating low‐grade infected nonunion from aseptic cases. A prospective multicenter clinical study enrolled 75 patients with femoral or tibial shaft nonunion with planned revision surgery and without clinical suspicion of infection. During revision surgery, tissue from the nonunion zone was sampled for culture and histopathology, and the implant for sonication with MF and colony forming unit (CFU) quantification. Infection was diagnosed according to the diagnostic criteria for fracture‐related infection. The diagnostic performance of MF CFU count was evaluated by receiver operating characteristic (ROC) curve and compared with that of tissue culture (TC), sonication fluid broth culture (SFC), and Histopathological Osteomyelitis Evaluation Score (HOES). Fifty‐three nonunion cases were aseptic, and 22 had a low‐grade infection. ROC curve had an area under the curve of 0.84. The optimal CFU cutoff to discriminate between low‐grade infected and aseptic nonunion was 11.1 CFU/10 mL sonication fluid with 64% sensitivity and 89% specificity. SFC showed a higher sensitivity of 82% but a lower specificity of 81%. The sensitivity and specificity of TC were 77% and 96%, respectively, and those of HOES were 9% and 87%, respectively. Implementation of MF in clinical diagnostics as an adjunct to TC may improve the differential diagnosis between low‐grade infected nonunion and aseptic nonunion.

To investigate nonunion rates and risk factors in patients with ipsilateral femoral neck and shaft fractures. Retrospective review. Two Level I trauma centers. Two hundred seven patients treated for ipsilateral femoral neck (AO/OTA 31-B) and shaft (AO/OTA 32A-C) fractures from 2013 to 2022. Patients with less than 6 months of follow-up were excluded. The primary outcome of this study was femoral shaft nonunion. Risk factors for nonunion were evaluated, including smoking, open fracture, delay to full weight-bearing, blood transfusions, and AO/OTA classification. Two hundred twenty-seven patients were initially identified, but only 154 patients had sufficient follow-up and were included in final analysis. The mean age was 38.9 years (SD = 15.3), and injury severity score was 19.5 (9.7). One hundred ten patients (71%) were male and 69 (45%) required intensive care unit care. Thirty-eight patients (25%) experienced an open fracture, and 44 fractures (29%) were AO/OTA Type C. Thirty patients (20%) underwent initial external fixation, and 88 patients (57%) received a perioperative transfusion. Thirty-four patients (22%) developed a femoral shaft nonunion, and 5 (3%) experienced a surgical site infection. Nonunion was associated with perioperative blood transfusion, AO/OTA Type C fracture, postoperative non-weight-bearing, and delay to full weight-bearing ≥12 weeks. Multivariable regression identified perioperative blood transfusion ≥3 (risk ratio [RR] = 1.91; CI, 1.12-2.72; P = 0.02) and AO/OTA Type C fracture (RR = 2.45; CI, 1.50-3.34; P = 0.001) as independent risk factors. Ipsilateral femoral neck and shaft fractures remain difficult injuries to treat. Much attention is given to diagnosis and treatment of the femoral neck component. These results suggest that successful treatment of the femoral shaft component presents its own challenges with high nonunion rates. Prognostic Level III.

Modified CLON technique for treating femoral shaft nonunion with substantial shortening: A case report

In recent years, plate augmentation over a retained intramedullary (IM) nail has been shown to be an effective option for managing femur fracture nonunions because it improves the biomechanical environment of the fracture site without causing additional biological damage. In the current study, we present outcome data from 22 consecutive patients treated with plate augmentation for femoral shaft nonunion leaving the nail in situ. Between 2015 and 2018, 22 consecutive patients with femoral shaft aseptic nonunion after IM nailing were treated with plate augmentation over a retained nail at four different institutions. Nonunion was categorized based on its anatomical location and was classified according to the Weber and Cech classification. Cortical defects greater than 1.0cm, the type of nailing procedure, and the number of previous interventions were recorded. Patients were assessed clinically and radiographically to measure the healing of nonunion sites. The time to fracture union and complications were recorded. Descriptive statistics were used when applicable. One site location was supra-isthmic, 12 were isthmic, and 9 were infra-isthmic. There were 10 cases of vascular nonunion and 12 cases of avascular nonunion. A cortical defect greater than 1.0cm was observed in three patients. Antegrade nailing was performed in 11 patients, and retrograde nailing was performed in 11 patients. Reaming was performed in 12 patients. In eight patients, the fracture was openly reduced during the IM nailing index procedure. The average number of previous interventions before augmentation plating was 1.6 (1-4). Bone union was achieved in 19 patients after augmentation plating with an average follow-up of 23.5months (12-51months). Excellent and good clinical results were observed in all patients. There was no plate or screw breakage, and no patient developed infection. Augmentation plating leaving the nail in situ is an excellent option for treating femoral shaft nonunion after IM nailing, with a high union rate and few complications. We believe the technique should gradually replace exchange nailing as the standard of care for the majority of femoral shaft nonunions that occur after IM nailing.