Safety aspects in surgical treatment of pathological fractures of the proximal femur – modular endoprosthetic replacement vs. intramedullary nailing
© Fakler et al.; licensee BioMed Central Ltd. 2013
Received: 18 October 2013
Accepted: 30 November 2013
Published: 7 December 2013
Pathologic fractures of the femoral intertrochanteric and subtrochanteric region require special consideration in terms of biomechanically stable fixation and durability of the implant. In addition, the type of surgery might also influence patient survival. We conducted this retrospective study to evaluate the safety of modular proximal femur replacement compared to intramedullary nailing with patient survival being the primary and complications the secondary endpoint.
We retrospectively studied the records of 20 consecutive patients with actual pathologic fracture due to bone metastasis in the intertrochanteric and subtrochanteric part of the femur. The pathologic fractures were stabilized with a locked cephalomedullary nail in 12 patients and treated with en-bloc resection and modular proximal femur replacement in eight patients.
In the tumor prosthesis group median patient survival was more than twice as high (4.5 months, IQR 2.3 – 16.5) than in the osteosynthesis group (2.0 months, IQR 0.3 – 20.5), but did not reach significance (p = 0.58). Besides, a significantly better preoperative general health status in patients with endoprosthetic reconstruction puts better survival into perspective. Median implant survivorship did not differ between groups with 2.5 (IQR 1.0 – 7.5) months for endoprothesis and 3.0 (IQR 0.3 – 11.0) months for osteosynthesis (p = 0.93). Complication rates were comparable with 25% in each group.
Patient survival was not influenced by type of surgery or choice of implant. Preoperative general health condition and ambulatory capacity may aid in decision for type of surgery and improve patient safety, respectively.
The most frequent site of extravertebral osseous metastatic lesions is located in the femur, specifically in the proximal part of it [1–3]. Bone metastases of the femoral head and neck with subsequent fractures usually are treated with conventional arthroplasty . On the contrary, pathologic fractures of the trochanteric region not only necessitate restoration of hip function, but also demand full weight-bearing capacity to the femoral diaphysis. Hence, pathologic fractures of the femoral intertrochanteric and subtrochanteric region require special consideration in terms of biomechanically stable fixation of the implant and restoration of lower limb function [4, 5]. Since healing of pathologic fractures can be expected in only about 35% of all pathologic fractures , durable reconstitution of load capacity in this biomechanically critical region must be provided by the implant itself in many cases. Apart from technical aspects, variable general health condition and indistinct survival time of patients with secondary osseous tumor lesions [4, 5, 7–9] impede decision making in terms of optimal surgical procedure and choice of implant. Although previous studies reported on strategies and outcome, optimal treatment is still under debate. Recently it was demonstrated, that patient survival may benefit from resection and modular replacement with a tumor prosthesis compared to intramedullary nailing in pathologic fracture of the proximal femur . We conducted this retrospective study to evaluate the safety of modular proximal femur replacement compared to intramedullary nailing in the treatment of pathologic trochanteric femoral fracture with respect to survival time of patients and implants as well as complications.
We retrospectively studied the records of 20 consecutive patients with pathologic fractures due to bone metastasis in the intertrochanteric and subtrochanteric part of the femur at the author’s institution from January 2003 to December 2012. Patients with an impending fracture as well as patients with a solitary metastasis were excluded for better reproducibility. All patients gave written consent for scientific analysis of their data. All bone metastases were confirmed by biopsy. All values are given as median values and the interquartile range IQR (25th-75th percentile). Median age of all patients was 69.8 years (IQR 61.8 – 74.0). Nine patients were female and eleven male. The median postoperative follow-up was 3.0 months (IQR 1.0 – 18.3). No patient was lost to follow-up. In order to estimate the general health condition preoperatively the Karnofsky performance status was used . A performance status of 80-100% was regarded as a good general health condition, 50-79% as moderate and 10-49% as poor. Walking ability was subdivided in three groups: ambulatory without any walking aids, ambulatory with walking aids and not ambulatory (wheel-chair or bed-bound). 15 of 20 patients (75%) also had vertebral metastases at the time of pathologic proximal femoral fracture. Hence, the Tokuhashi-Score was calculated to predict patient survival .
The pathologic fractures were stabilized with a locked cephalomedullary nail in 12 patients in the osteosynthesis group and treated with en-bloc resection and modular proximal femur replacement in eight patients in the tumor prosthesis group. With respect to osteosynthetic stabilization a proximal femoral antirotation nail with a spiral blade (PFNA, Synthes, Oberdorf, Switzerland) was used in two cases and cephalomedullary nail (Sirus, Zimmer, Freiburg, Germany) in the remaining ten patients. In three patients curettage and cementation was performed additionally. Two patients primarily treated with a cephalomedullary nail were converted to a cemented proximal femoral replacement after early failure of the osteosynthesis three and five months after operation (cut out of the cephalic screw and implant breakage). In eight patients the tumor prosthesis was implanted primarily. All patients with resection received a cemented modular proximal femoral replacement (MUTARS, Implantcast, Buxtehude, Germany). Hemiarthroplasty as well as total arthroplasty was performed in four patients. A lateral approach was performed in all proximal femoral replacements.
The patient survival was assessed by the time interval from operation until death or last follow-up for patients alive. Implant survivorship was determined as the time period from the operation until death, last follow-up of patients alive or re-operation for any reason at the same site of the operation. Implant durability was defined as the time period from operation until death, last follow-up, or implant exchange due to structural failure as for secondary fracture dislocation, periimplant/periprosthetic fracture, hardware failure or loosening.
Patient survival was defined as primary outcome with implant survival and complications rates being secondary endpoints. Correspondingly, our primary hypothesis was that patient and implant survival is higher for megaendoprosthetic replacement compared to osteosynthesis. Due to the retrospective nature of this study structural equality of groups cannot be assumed, subsequently a power-analysis was not performed. Statistical analysis was performed with the PASW software version 20 (SPSS Inc., Chicago, IL, USA). Comparison and testing for differences in both groups was assessed with the Mann-Whitney-U test. For patient and implant survival the Kaplan-Meier analysis was applied, differences were determined by log-rank analysis. Differences were considered statistically significant when the p value was less than 0.05.
Survival of all patients at six and twelve months was 45.0% and 35.0%, respectively. At two years three patients were alive (15.0%). At the last follow-up three patients were still alive 22, 35 and 45 months after operation.
Age, time periods and survival
Proximal femoral replacement
Age at operation (years)
61.9 (59.5 – 72.7)
73.8 (66.5 – 80.4)
Time from initial diagnosis to operation (months)
54.5 (4.8 – 87.3)
24.0 (1.0 – 64.3)
Patient survival since operation (months)
4.5 (2.3 – 16.5)
2.0 (0.3 – 20.5)
Implant survival (months)
2.5 (1.0 – 7.5)
3.0 (0.3 – 11.0)
Implant durability (months)
4.5 (2.3 – 16.5)
2.0 (0.3 – 11.0)
Patient survival since initial diagnosis (months)
65.0 (10.8 – 112.0)
30.0 (1.5 – 87.5)
Preoperative health condition and ambulatory capacity
Proximal femoral replacement
65.0 (52.5 – 90.0)
45.0 (30.0 – 50.0)
7.0 (6.3 – 8.0)
6.0 (5.3 – 7.8)
With walking aids (n)
Wheel chair/bed bound (n)
An additional analysis was performed accounting the two early osteosynthesis failures with implant exchange to the prosthesis group. Nevertheless, no significant differences with respect to patient survival and implant survivorship were found.
In terms of patient survival it is very difficult to estimate the role of the surgical method or choice of implant. Many cofactors have shown to influence patient survival in metastatic bone disease as age, preoperative general health status, type of cancer, location of metastasis in the femur or solitary versus multiple metastases [11–14]. Apart from these factors actual fracture compared to impending fracture in long bones seems to be another essential cause influencing patient survival [5, 7]. Mavrogenis et al.  demonstrated that impending fractures show a significantly better life expectancy with survival rates of approximately 60% at one year, 40% at two years, 30% at three years and 20% after 5 years. Survival rates of actual pathologic femoral fracture are reported to be approximately 45% at six months, 30% at one year, 15% at two years and less than 10% after 3 years [4, 5, 15], corresponding well to our results. Mavrogenis et al. additionally found that the type of surgery is a significant factor in patient survival. This was also demonstrated for pathologic fractures of the proximal femur. Patient survival was significantly higher in 18 patients with proximal femoral resection and modular prosthetic replacement compared to 11 patients with intramedullary nailing . According to these results our primary hypothesis was to confirm superior survival in patients undergoing proximal femoral resection and endoprothetic reconstruction compared to intramedullary osteosynthesis. Although we could see a tendency to better survival in the prosthetic group it was statistically not significant. Besides, preoperative general health performance which is a substantial predictor of survival in skeletal metastases [11, 12] was significantly lower in the osteosynthesis group contributing to an earlier death and putting a better survival by trend in the prosthesis group into perspective. Preoperative general health performance was not reported by Mavrogenis et al. Consequently, the benefit in patient survival after resection and endoprosthesis in their study might be equivocal .
None of the patients in our series died because of intraoperative embolic events. It has been shown by others that implantation of a long intramedullary nail or a long-stem cemented femoral component in patients with femoral metastasis increases the risk of an embolic syndrome considerably resulting in catastrophic outcome in up to 8% [16–19]. We believe that cemented stems with a regular length and modular reconstruction bushings bridging the osseous defect as applied in our study may help in reducing the risk of an embolic syndrome und increase patient safety.
Preoperative general health status is an important parameter in predicting survival in patients with skeletal metastases [11, 12]. Unfortunately, many authors do not report on this [4, 5, 9]. As for our study groups we demonstrated a significant difference suggesting a profound selection bias. Correspondingly, most of the patients with a poor preoperative health condition were treated with an intramedullary nail and patients with moderate to good general performance received endoprosthetic reconstruction. It should be mentioned that two out of four patients with a good preoperative general health condition and normal ambulatory capacity in the osteosynthesis group sustained a hardware failure. This is in contrast to the results of Steensma et al. . They reported a preoperative Eastern Cooperative Oncology Group (ECOG) Score of 2 points or less in 88% of patients treated with an intramedullary nail (IM) compared to only 61% in the endoprosthesis group. That means almost all patients in the IM group were ambulatory and had a moderate to very good preoperative health status preoperatively. Nevertheless, a good health status and a subsequently higher activity of patients did not contribute to a higher implant related complication rate after nailing which was 6.1% and is considerably lower than in our IM group. A possible explanation might be the relatively high rate of impending fractures (70%) as discussed above .
Despite the relatively small number of patients our study holds several strengths compared to other larger series [4, 7–9]. First, we focused on the actual pathologic fracture and its corresponding characteristic features outlined above, exclusively. Second, we included only patients with multiple osseous metastases and fracture location in the proximal femur, excluding further potential confounding variables. Third, we addressed the preoperative general health performance which is a major prognostic factor in patient survival and correspondingly supported interpretation of survival data which is rarely reflected in other studies. On the other hand, several limitations of our study must be mentioned. First, the retrospective design and relatively small number of patients in the study comprise familiar limitations by itself. Nevertheless, actual pathologic fractures are quite rare and survival of patients is limited qualifying this type of study. Second, many different types of cancer were included. However, distribution of cancer type according to aggressiveness  was comparable with approximately 60% of slow to moderate growth types in each group. Third, adjuvant and neoadjuvant therapy was not considered. But a wide divergence of treatment protocols and unclear effectiveness  precluded inclusion of this criterion.
In summary, pathologic fractures are treated equally safe by osteosynthesis using an intramedullary nail or proximal femoral resection and endoprosthetic reconstruction. Patient survival was not influenced by type of surgery or choice of implant. Patients that show a good to moderate general health status and are ambulatory preoperatively might benefit from primary endoprosthetic reconstruction due to longer implant durability. The only concerning complication after proximal femoral resection and endoprosthetic reconstruction in our series was dislocation which must be prevented in order to see a clear benefit over intramedullary nailing in patients with expected longer survival.
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