What Factors Are Associated With Implant Breakage and Revision After Intramedullary Nailing for Femoral Metastases?

BACKGROUND: Actual and impending pathologic fractures of the femur are commonly treated with intramedullary nails because they provide immediate stabilization with a minimally invasive procedure and enable direct weightbearing. However, complications and revision surgery are prevalent, and despite common use, there is limited evidence identifying those factors that are associated with complications. QUESTIONS/PURPOSES: Among patients treated with intramedullary nailing for femoral metastases, we asked the following questions: (1) What is the cumulative incidence of local complications? (2) What is the cumulative incidence of implant breakage and what factors are associated with implant breakage? (3) What is the cumulative incidence of revision surgery and what factors are associated with revision surgery? METHODS: Between January 2000 and December 2015, 245 patients in five centers were treated with intramedullary nails for actual and impending pathologic fractures of the femur caused by bone metastases. During that period, the general indications for intramedullary nailing of femoral metastases were impending fractures of the trochanter region and shaft and actual fractures of the trochanter region if sufficient bone stock remained; nails were used for lesions of the femoral shaft if they were large or if multiple lesions were present. Of those treated with intramedullary nails, 51% (117) were actual fractures and 49% (111) were impending fractures. A total of 60% (128) of this group were women; the mean age was 65 years (range, 29-93 years). After radiologic followup (at 4-8 weeks) with the orthopaedic surgeon, because of the palliative nature of these treatments, subsequent in-person followup was performed by the primary care provider on an as-needed basis (that is, as desired by the patient, without any scheduled visits with the orthopaedic surgeon) throughout each patient's remaining lifetime. However, there was close collaboration between the primary care providers and the orthopaedic team such that orthopaedic complications would be reported. A total of 67% (142 of 212) of the patients died before 1 year, and followup ranged from 0.1 to 175 months (mean, 14.4 months). Competing risk models were used to estimate the cumulative incidence of local complications (including persisting pain, tumor progression, and implant breakage), implant breakage separately, and revision surgery (defined as any reoperation involving the implant other than débridement with implant retention for infection). A cause-specific multivariate Cox regression model was used to estimate the association of factors (fracture type/preoperative radiotherapy and fracture type/use of cement) with implant breakage and revision, respectively. RESULTS: Local complications occurred in 12% (28 of 228) of the patients and 6-month cumulative incidence was 8% (95% confidence interval [CI], 4.7-11.9). Implant breakage occurred in 8% (18 of 228) of the patients and 6-month cumulative incidence was 4% (95% CI, 1.4-6.5). Independent factors associated with increased risk of implant breakage were an actual (as opposed to impending) fracture (cause-specific hazard ratio [HR_cs], 3.61; 95% CI, 1.23-10.53, p = 0.019) and previous radiotherapy (HR_cs, 2.97; 95% CI, 1.13-7.82, p = 0.027). Revisions occurred in 5% (12 of 228) of the patients and 6-month cumulative incidence was 2.2% (95% CI, 0.3-4.1). The presence of an actual fracture was independently associated with a higher risk of revision (HR_cs, 4.17; 95% CI, 0.08-0.82, p = 0.022), and use of cement was independently associated with a lower risk of revision (HR_cs, 0.25; 95% CI, 1.20-14.53, p = 0.025). CONCLUSIONS: The cumulative incidence of local complications, implant breakage, and revisions is low, mostly as a result of the short survival of patients. Based on these results, surgeons should consider use of cement in patients with intramedullary nails with actual fractures and closer followup of patients after actual fractures and preoperative radiotherapy. Future, prospective studies should further analyze the effects of adjuvant therapies and surgery-related factors on the risk of implant breakage and revisions. LEVEL OF EVIDENCE: Level III, therapeutic study.

Pathologic fractures of the distal femur: Current concepts and treatment options.

Pathologic fractures of the distal femur caused by bone metastases are not as common as those in the proximal femur but provide great difficulty to adequately treat. This systematic review shows that insufficient literature exists to draw clinically relevant conclusions for essential questions, such as "what factors indicate an endoprosthetic reconstruction for distal femur pathologic fractures?" Due to paucity of literature in the systematic review, a current concepts review (including treatment flowchart), based on instructional reviews and experience, was also performed.

A prediction model for treatment decisions in high-grade extremity soft-tissue sarcomas: Personalised sarcoma care (PERSARC).

BACKGROUND: To support shared decision-making, we developed the first prediction model for patients with primary soft-tissue sarcomas of the extremities (ESTS) which takes into account treatment modalities, including applied radiotherapy (RT) and achieved surgical margins. The PERsonalised SARcoma Care (PERSARC) model, predicts overall survival (OS) and the probability of local recurrence (LR) at 3, 5 and 10 years. AIM: Development and validation, by internal validation, of the PERSARC prediction model. METHODS: The cohort used to develop the model consists of 766 ESTS patients who underwent surgery, between 2000 and 2014, at five specialised international sarcoma centres. To assess the effect of prognostic factors on OS and on the cumulative incidence of LR (CILR), a multivariate Cox proportional hazard regression and the Fine and Gray model were estimated. Predictive performance was investigated by using internal cross validation (CV) and calibration. The discriminative ability of the model was determined with the C-index. RESULTS: Multivariate Cox regression revealed that age and tumour size had a significant effect on OS. More importantly, patients who received RT showed better outcomes, in terms of OS and CILR, than those treated with surgery alone. Internal validation of the model showed good calibration and discrimination, with a C-index of 0.677 and 0.696 for OS and CILR, respectively. CONCLUSIONS: The PERSARC model is the first to incorporate known clinical risk factors with the use of different treatments and surgical outcome measures. The developed model is internally validated to provide a reliable prediction of post-operative OS and CILR for patients with primary high-grade ESTS. LEVEL OF SIGNIFICANCE: level III.

Cross-Cultural Adaptation, Translation, and Validation of the Toronto Extremity Salvage Score for Extremity Bone and Soft Tissue Tumor Patients in Netherlands.

PURPOSE: The aim of this study was to translate and culturally adapt the Toronto Extremity Salvage Score (TESS) to Dutch and to validate the translated version. METHODS: The TESS lower and upper extremity versions (LE and UE) were translated to Dutch according to international guidelines. The translated version was validated in 98 patients with surgically treated bone or soft tissue tumors of the LE or UE. To assess test-retest reliability, participants were asked to fill in a second questionnaire after one week. Construct validity was determined by computing Spearman rank correlations with the Short Form- (SF-) 36. RESULTS: The internal consistency (0.957 and 0.938 for LE and UE, resp.) and test-retest reliability (intraclass correlation coefficients 0.963 and 0.969 for LE and UE, resp.) were good for both questionnaires. The Dutch LE and UE TESS versions correlated most strongly with the SF-36 physical function dimension (r = 0.737 for LE, 0.726 for UE) and the physical component summary score (r = 0.811 and 0.797 for LE and UE). INTERPRETATION: The Dutch TESS questionnaire for lower and upper extremities is a consistent, reliable, and valid instrument to measure patient-reported physical function in surgically treated patients with a soft tissue or bone tumor.

Individualised risk assessment for local recurrence and distant metastases in a retrospective transatlantic cohort of 687 patients with high-grade soft tissue sarcomas of the extremities: a multistate model.

OBJECTIVES: This study investigates the effect of surgical margins and radiotherapy, in the presence of individual baseline characteristics, on survival in a large population of high-grade soft tissue sarcoma of the extremities using a multistate model. DESIGN: A retrospective multicentre cohort study. SETTING: 4 tertiary referral centres for orthopaedic oncology. PARTICIPANTS: 687 patients with primary, non-disseminated, high-grade sarcoma only, receiving surgical treatment with curative intent between 2000 and 2010 were included. MAIN OUTCOME MEASURES: The risk to progress from 'alive without disease' (ANED) after surgery to 'local recurrence' (LR) or 'distant metastasis (DM)/death'. The effect of surgical margins and (neo)adjuvant radiotherapy on LR and overall survival was evaluated taking patients' and tumour characteristics into account. RESULTS: The multistate model underlined that wide surgical margins and the use of neoadjuvant radiotherapy decreased the risk of LR but have little effect on survival. The main prognostic risk factors for transition ANED to LR are tumour size (HR 1.06; 95% CI 1.01 to 1.11 (size in cm)) and (neo)adjuvant radiotherapy. The HRs for patients treated with adjuvant or no radiotherapy compared with neoadjuvant radiotherapy are equal to 4.36 (95% CI 1.34 to 14.24) and 14.20 (95% CI 4.14 to 48.75), respectively. Surgical resection margins had a protective effect for the occurrence of LR with HRs equal to 0.61 (95% CI 0.33 to 1.12), and 0.16 (95% CI 0.07 to 0.41) for margins between 0 and 2 mm and wider than 2 mm, respectively. For transition ANED to distant metastases/Death, age (HR 1.64 (95% CI 0.95 to 2.85) and 1.90 (95% CI 1.09 to 3.29) for 25-50 years and >50 years, respectively) and tumour size (1.06 (95% CI 1.04 to 1.08)) were prognostic factors. CONCLUSIONS: This paper underlined the alternating effect of surgical margins and the use of neoadjuvant radiotherapy on oncological outcomes between patients with different baseline characteristics. The multistate model incorporates this essential information of a specific patient's history, tumour characteristics and adjuvant treatment modalities and allows a more comprehensive prediction of future events.

Lack of clinical evidence for postoperative radiotherapy after surgical fixation of impending or actual pathologic fractures in the long bones in patients with cancer; a systematic review.

Patients with disseminated cancer and bone metastases have a limited life expectancy and therefore any treatment should have a clear beneficial effect, outweighing all possible downsides. This systematic review aims to identify and evaluate available evidence regarding function, pain, quality of life, survival and complications of postoperative radiotherapy (RT) after surgical stabilization of impending or actual pathologic fractures of the long bones due to bone metastases. A literature search resulted in two articles reporting on 64 and 110 patients of whom 55% and 28% received postoperative RT, respectively. Both studies were retrospective cohort studies and postoperative RT had been administered depending on the surgeons' choice. The first study reported better outcomes regarding function, re-interventions and survival in patients receiving postoperative RT. The second study reported no significant difference regarding complications between the two groups. The quality of the evidence was very low due to the observational character of both studies, risk of indication bias, small study sizes, use of non-standardized outcome measures, and limited statistical analyses. The current available literature is insufficient to conclude whether postoperative RT after surgical stabilization should be standard care. It is important to realize this lack of clear evidence when calling upon RT as adjuvant palliative treatment.

Treatment of pathological fractures of the long bones.

Bone metastases of the long bones often lead to pain and pathological fractures. Local treatment consists of radiotherapy or surgery. Treatment strategies are strongly based on the risk of the fracture and expected survival.Diagnostic work-up consists of CT and biopsy for diagnosis of the primary tumour, bone scan or PET-CT for dissemination status, patient history and blood test for evaluation of general health, and biplanar radiograph or CT for evaluation of the involved bone.A bone lesion with an axial cortical involvement of >30 mm has a high risk of fracturing and should be stabilised surgically.Expected survival should be based on primary tumour type, performance score, and presence of visceral and cerebral metastases.Radiotherapy is the primary treatment for symptomatic lesions without risk of fracturing. The role of post-operative radiotherapy remains unclear.Main surgical treatment options consist of plate fixation, intramedullary nails and (endo) prosthesis. The choice of modality depends on the localisation, extent of involved bone, and expected survival. Adjuvant cement should be considered in large lesions for better stabilisation. Cite this article: Willeumier JJ, van der Linden YM, van de Sande MAJ, Dijkstra PDS. Treatment of pathological fractures of the long bones. EFORT Open Rev 2016;1:136-145. DOI: 10.1302/2058-5241.1.000008.