Patients who had sustained any periprosthetic femur fracture were identified within each group. Electronic medical records, operative reports, and radiographs were reviewed to examine the timing, fracture pattern, and subsequent treatments. Immediate postoperative radiographs were reviewed for all patients who sustained a postoperative fracture to look for any evidence of missed intraoperative fracture. All fractures were described according to the Vancouver classification, which takes into account fracture location, implant stability, and bone quality .
Descriptive statistics are reported as number (percentage), and continuous variables are reported as mean (± SD). Univariate Cox proportional hazards regression analysis was performed to assess the association of variables with the risk of any postoperative fracture, fracture requiring reoperation, and fracture requiring stem revision with results reported as hazard ratios (HRs) with 95% confidence intervals (CIs). A multivariate analysis was also performed to assess the risk of postoperative fracture with patient variables including group, age, sex, BMI, intraoperative fracture, and preoperative diagnosis. Kaplan-Meier estimates were calculated for patient survival, free of postoperative periprosthetic fractures, fractures requiring reoperation, and fractures requiring revision, with results reported as percentage (95% CI) . The α level was set at 0.05 for statistical significance.
Fracture Frequency and Implant Survivorship
Patients in the PL group had an increased incidence of postoperative fracture and worse implant survival than patients in the non-PL group. A total of 39 postoperative fractures were identified in the PL group, including eight Vancouver AG, four Vancouver B1, and 27 Vancouver B2 fractures. In contrast, there were 28 fractures in the non-PL group, including 10 Vancouver AG, one Vancouver AL, five Vancouver B1, and 12 Vancouver B2 fractures. The Kaplan-Meier estimate for patient survival, free of any postoperative fracture, was 98.4% (range, 97.4%-99.3%), 97.1% (range, 95.9%-98.3%), 95.4% (range, 93.8%-97.0%), and 92.6% (range, 89.6%-95.3%) at 30 days, 1 year, 5 years, and 10 years, respectively, for the PL patient group, compared with 99.8% (range, 99.7%-99.9%), 99.6% (range, 99.3%-99.8%), 99.3% (range, 99.0%-99.6%), and 98.4% (range, 97.5%-99.1%) in the non-PL patient group (p < 0.001; Table 3).
In addition to having a higher incidence of postoperative fracture, hips in the PL group were more likely to present with a fracture pattern that required surgical treatment. Of the 39 fractures in the PL group, 30 (76%) were treated surgically, including use of open reduction internal fixation (ORIF) in five of 39 (13%) fractures and stem revision in 25 of 39 (64.1%) fractures. In contrast, 14 of 28 (50%) fractures were treated operatively in the non-PL group, including three of 28 (11%) treated with ORIF and 11 of 28 fractures (39%) treated with stem revision (p < 0.001). Kaplan-Meier estimates for patient survival, free of reoperation and stem revision, are shown (Table 3). At the time of revision for fracture, we routinely found HA resorption and poor ongrowth associated with the ProxiLock stem (Fig. 2).
At latest followup, 33 (4.5%) stem revisions had been performed in the PL group with diagnoses including fracture, 25 (3.4%); symptomatic loosening, seven (1%); and infection, one (0.1%). In the non-PL group, fewer stems were revised (32 [1%]), including 15 (0.5%) for infection, 11 (0.3%) for fracture, and six (0.2%) for symptomatic loosening (p < 0.001).
Time to Fracture
An increased fracture probability was present in the PL group at all time points encompassing both early and late fractures. In the PL group, the cumulative probability of fracture was 1.6% (0.7%-2.6%) at 30 days, 2.5% (1.3%-3.6%) at 90 days, 2.9% (1.7%-4.1%) at 1 year, 4.6% (3.0%-6.2%) at 5 years, and 7.4% (4.7%-10.4%) at 10 years. In the non-PL group, the cumulative probability of fracture was 0.2% (0.04%-0.3%) at 30 days, 0.3% (0.1%-0.5%) at 90 days, 0.4% (0.2%-0.7%) at 1 year, 0.7% (0.04%-1%) at 5 years, and 1.6% (0.8%-2.5%) at 10 years (p < 0.001; Fig 3).
Patient characteristics were similar between patients who sustained early (≤ 90 days) and late (> 90 days) fractures within the PL group with regard to age (64.6 ± 12.7 years versus 68.5 ± 11.4 years, p = 0.32) and female sex (61.1% versus 52.4%, p = 0.41). Furthermore, fracture type was also similar between early and late fractures within the PL group. Of 18 early fractures, four (22.2%) were Vancouver AG and 14 (77.8%) were Vancouver B2, similar to the 21 late fractures, which consisted of four (19%) Vancouver AG, four (19%) Vancouver B1, and 13 (62%) Vancouver B2 (p = 0.82). Within the non-PL group, age was similar between patients with early and late fractures (67.4 ± 12.9 years vs 62.7 ± 10.2 years, p = 0.30), but there tended to be a higher proportion of females among the early fractures than late fractures (66.7% versus 31.6%, p = 0.08). Of nine early fractures in the non-PL group, two (22.2%) were Vancouver AG, one (11.1%) was a Vancouver B1, and six (66.7%) were Vancouver B2. In contrast, 19 late fractures consisted of eight (42.1%) Vancouver AG, one (5.3%) Vancouver AL, four (21.1%) Vancouver B1, and six (31.6%) Vancouver B2 (p = 0.12).
Predictive Risk Factors
Use of a ProxiLock stem and age older than 60 years were risk factors for postoperative fracture, fracture requiring reoperation, and fracture requiring stem revision. After controlling for confounding variables including patient sex, age, BMI, primary diagnosis, and intraoperative fracture, use of a ProxiLock stem demonstrated an increased risk of postoperative fracture (HR, 5.0; 95% CI, 3.1- 8.2; p < 0.001). Age older than 60 years was also a risk factor (HR, 3.7; 95% CI, 2.1-6.4; p < 0.001). Patient sex, BMI, and preoperative diagnosis were not risk factors (Table 4).
There were 36 (4.9%) recognized intraoperative fractures in the PL group, which was similar to the rate in the non-PL group (139 [4.3%]). Use of a ProxiLock stem did not lead to increased risk of intraoperative fracture (HR, 1.1; 95% CI, 0.8-1.7; p = 0.48). Of the 36 PL group patients who sustained an intraoperative fracture, three developed a subsequent postoperative fracture. In one instance, a nondisplaced calcar crack was treated with a single Luque wire. The patient did well until sustaining a Vancouver B1 fracture after a ground-level fall 4 years postoperatively, which was treated with ORIF. In another instance, a small trochanteric avulsion fracture occurred during hip reduction and was treated with suture repair and a postoperative hip abduction brace, but the patient fell and sustained a Vancouver B2 fracture requiring stem revision 8 weeks postoperatively. In the third case, a trochanteric crack was noted during preparation of the femoral canal, which was repaired using Dacron tape suture, but the patient was involved in a tractor rollover accident 3 weeks postoperatively, which resulted in a Vancouver B2 fracture, requiring stem revision. After reviewing the immediate postoperative radiographs for all patients who sustained a postoperative fracture, we were unable to identify any unrecognized intraoperative fractures.
Cementless, proximally fixed, tapered femoral components have been among the most frequently used for primary THA. Their design relies on press-fit and three-point fixation to achieve initial stability. Because the viscoelastic proximal femur then gradually accommodates to the press-fit, implant subsidence is prevented by three-point fixation, the tapered geometry, and surface treatments . Stability must be maintained in this manner with micromotion less than 20 μm until biologic fixation is obtained, a process that may require up to 12 weeks . Gradual loading of the proximal femur and tapered geometries have resulted in reduced stress shielding and thigh pain, respectively [12, 16]. Despite advances made in THA surgical technique and implant technology, periprosthetic fracture continues to be a problem causing severe patient morbidity [5, 13-15]. Although several studies have previously reported on the epidemiology of periprosthetic femur fracture, there are little data pertaining to the fracture risk of particular cementless stems. Sheth et al found that metaphyseal engaging stems, especially flat tapered stems, led to an increased risk of periprosthetic femur fracture compared with cemented and diaphyseal engaging stems . However, we are not aware of any studies that describe variations of fracture risk within the same class of cementless femoral stems. The aims of our study were to determine the (1) frequency of periprosthetic femur fracture and implant survivorship; (2) time to fracture in those patients who experienced periprosthetic femur fracture; and (3) predictive risk factors for periprosthetic femur fracture between ProxiLock stems and other contemporary cementless, proximally fixed tapered stems in patients who underwent primary THA.
There are limitations to our study. Foremost, although our data were prospectively collected, the data were examined retrospectively. Because of this, it is possible that important differences existed between the PL and non-PL groups. For example, patients in the PL group were found to be older with a higher proportion of males. Although these differences were small and not likely to be clinically important, it is possible there are other differences that were not identified by this study such as differences in femoral bony geometry or nuanced surgeon indications for use of the ProxiLock stem, which may have influenced the risk of fracture. Furthermore, our study cohorts were not matched; however, to make our comparisons as applicable as possible, the non-PL group included only uncemented stems that were tapered, proximally fixed, and implanted during the same period of time as the PL group. Additionally, our ability to definitively explain the cause of fracture, especially late fracture, is limited because radiographs were not routinely taken within a short time preceding fracture, which makes it impossible to describe findings such as loosening, subsidence, or osteolysis, which could predispose to fracture. Lastly, because no cobalt-chromium beaded versions of the PL stem were implanted at our institution, our results only apply to the HA-coated version.
The prevalence of postoperative periprosthetic femur fracture after primary THA has previously been described as 0.4% to 1.1% [5, 11, 13, 14]. Although the prevalence of fracture in our non-PL group patients was comparable to this rate (0.87%), in our study, fractures were much more common in the PL group (5.3%). More importantly, a larger proportion of PL patients presented with fracture types that required reoperation or stem revision. Fracture was the second most common reason for revision in the non-PL group, accounting for 11 of 32 (34.4%) of revisions. However, in the PL group, periprosthetic fracture was the number one reason for stem revision, accounting for 25 of 33 (75.8%) revisions.
We found that an increased probability of fracture was present at all time points in the PL group compared with other cementless stems, including both early and late fractures. The timing of postoperative fractures has important implications. Early fractures are most likely the result of missed intraoperative fractures or stem subsidence before osseointegration. Because the rate of intraoperative fracture was similar between the PL and non-PL groups and no cases of missed intraoperative fracture could be identified after reviewing immediate postoperative radiographs, it would seem unlikely that missed intraoperative fractures account for the increased risk of early postoperative fractures in the PL group. In regard to late fractures, it is somewhat puzzling why an increased risk would exist once a cementless stem has theoretically attained biologic osseointegration. However, epidemiologic studies demonstrate that cementless stems are in fact associated with an increased risk of late fracture compared to cemented stems [14, 15, 17]. With this in mind, late fractures could be the result of diminishing bone quality, osteolysis, or stem loosening/failure to osseointegrate and subsidence.
Our data showed that use of the HA-coated ProxiLock stem was a risk factor for postoperative periprosthetic femur fracture (HR, 5.6), fracture requiring reoperation (HR, 8.4), and fracture requiring stem revision (HR, 9.1) compared with all other cementless, proximally fixed tapered stems implanted at our institution during the same time interval. When taking all stem designs into consideration, patient age older than 60 years was also a risk factor for the same outcomes with HRs of 3.7, 4.2, and 4.5, respectively. Our findings are consistent with a study by Cook et al, which noted that patients aged older than 70 years had a 2.9 times greater risk of periprosthetic femur fracture, but found no increased risk associated with female sex (HR 1.5 in our study) . Intraoperative fractures occurred with similar frequency in both of our study groups and did not increase the risk of postoperative fractures.
Although we are not able to definitively explain the reason for the increased frequency of fracture in the ProxiLock group, we propose that multiple factors pertaining to the stem itself may contribute. Foremost, the stem geometry is unique. Although the majority of three-dimensional tapered stems use a 3° taper that spans the entire stem length, the ProxiLock taper has two distinct transition points: from a smooth distal cylinder to a 3.5° per side circumferential taper at midstem and then to a 7° per side circumferential flare proximally. For early fractures (before osseointegration), this pronounced double wedge could predispose to fracture in the setting of an axial force or subsidence, especially with a polished distal cylinder, which provides less axial support than stems that are grit-blasted and tapered distally. Explaining late fractures is made difficult by the lack of radiographs immediately preceding fracture. However, we found that most late fractures in the PL group were Vancouver B2 fractures with HA resorption and poor ongrowth but little or no osteolysis noted at the time of revision. This leads us to suggest that HA resorption compounded by lack of distal fixation and an exaggerated proximal taper may lead to gradual loosening and subsidence with a subsequent increased risk of late periprosthetic femur fracture.
In summary, use of the HA-coated ProxiLock stem in THA is associated with a high rate of postoperative periprosthetic femur fracture and, importantly, with fracture types necessitating reoperation or stem revision. The ProxiLock stem has not been used at our institution since 2008, and it has recently been discontinued by the manufacturer. Nevertheless, the findings reported in this study are important considerations for patients with existing ProxiLock stems and may be especially valid for those with evidence of loosening or stem subsidence. Furthermore, these findings are important in regard to future implant design. Specific design features that may increase the risk of fracture include exaggerated proximal tapers, lack of axial support from the distal stem, and HA coating on relatively smooth ongrowth surfaces. Additional understanding could be gleaned from retrieval analysis of failed HA-coated ProxiLock stems or outcome studies of the beaded cobalt-chrome version.
We thank Youlonda A. Loechler for her assistance in the data collection and W. Scott Harmsen and Kristin Fruth for their statistical expertise.
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