Before the 1970s, the majority of high-grade musculoskeletal tumors involving the distal femur were treated with transfemoral amputation owing to an unacceptably high rate of recurrence associated with local resection [10, 19, 31, 47]. As effective chemotherapeutic regimens were developed, limb salvage using various techniques gained popularity among orthopaedic oncologists [1, 11, 19, 20, 24, 37, 45, 49, 60, 69]. Today, with effective neoadjuvant chemotherapy, limb salvage is indicated in as much as 90% of patients with musculoskeletal malignancies involving the distal femur [6, 7, 14, 44, 53–55, 57].
Numerous studies document relatively high implant survival after limb salvage for tumors involving the distal femur [3, 4, 8, 26, 27, 29, 35, 43, 44, 50, 54, 55, 57, 61, 71]. Studies that are available, however, do not stratify patients on the basis of tumor grade, stage of disease, or life expectancy to define the disease-specific survival of implants. This makes it difficult for surgeons to accurately predict how long the implants will last for a given patient population and life expectancy. Additionally, there are limited data available with which to compare implant survival of contemporary modular implant designs with older custom-designed implants no longer in use [8, 44, 48, 70]. Critics of a cemented endoprosthetic reconstruction technique cite rates of aseptic loosening from 8.4% to greater than 30% [2, 30, 38, 63] as the main rationale for abandoning its use in favor of newer designs.
Given the paucity of long-term data concerning cemented distal femoral implants and the heightened interest in alternate fixation designs, we sought to answer the following four questions: (1) Do newer cemented modular implant designs have improved survivorship compared with older custom-designed components? (2) Does tumor grade or stage influence implant survival? (3) What is the typical long-term functional result after a cemented distal femoral replacement? (4) What are the complications associated with this technique?
|
Diagnosis |
Number of patients |
|---|---|
|
Group 1 (low grade) |
|
|
Giant cell tumor |
18 (9.7%) |
|
Parosteal osteosarcoma |
14 (7.5%) |
|
Chondrosarcoma (low grade) |
7 (3.8%) |
|
Desmoid of bone |
3 (1.6%) |
|
Chondroblastoma |
1 (0.5%) |
|
Total Group 1 |
43 (23.1%) |
|
Group 2 (high-grade localized) |
|
|
Osteosarcoma (classic high grade) |
102 (54.8%) |
|
Chondrosarcoma (high grade) |
7 (3.8%) |
|
Malignant fibrous histiocytoma |
5 (2.7%) |
|
Ewing’s sarcoma |
2 (1.1%) |
|
Synovial sarcoma |
2 (1.1%) |
|
Malignant giant cell tumor |
1 (0.5%) |
|
Leiomyosarcoma |
1 (0.5%) |
|
Fibrosarcoma |
1 (0.5%) |
|
Alveolar soft parts sarcoma |
1 (0.5%) |
|
Total Group 2 |
122 (65.6%) |
|
Group 3 (Stage III/disseminated) |
|
|
Osteosarcoma (Stage III) |
11 (5.9%) |
|
Metastatic disease |
4 (2.2%) |
|
Malignant fibrous histiocytoma |
2 (1.1%) |
|
Fibrosarcoma |
2 (1.1%) |
|
Myeloma |
1 (0.5%) |
|
Lymphoma |
1 (0.5%) |
|
Total Group 3 |
21 (11.3%) |
|
Total all groups |
186 (100.0%) |
From the charts, we recorded the index diagnosis and disease stage at the time of presentation (according to the system described by Enneking et al. [22, 25]), length of followup, postoperative function scores, implant type and manufacturer, and any major postoperative events (systemic or local complications, repeat surgery for any reason, revision of stemmed components, and/or local recurrence).
All endoprosthetic reconstructions were performed by the same surgeon (JJE), and all tumor resections followed generally accepted oncologic principles [7, 12, 14, 15]. A longitudinal medial incision extended from the tibial tubercle proximally following the course of the sartorius muscle, and the neurovascular bundle was identified and protected. Tourniquets were never used. All previous open biopsy sites were left in continuity with the resected mass; needle biopsy sites were ignored. The femoral and tibial osteotomies were made with the intention that postreconstruction leg lengths would be equal. A rotating-hinge knee mechanism was used in all cases that incorporated an 8-mm all-polyethylene nonmetal-backed tibial component. The distance between the distal end of the metal femoral component and the undersurface of the all-polyethylene tibial component when assembled was 17 mm. To ensure leg length equality, the femoral osteotomy was made 1 cm longer than the femoral component length, and 7 mm of proximal tibia was resected. The location of the patella relative to the joint line was never a conscious consideration. The level of resection was marked on the femur proximally with an osteotome, followed by a slightly more proximal mark on the femur and a mark on the proximal tibia (distal to the level of resection). The distance between the latter two marks was measured and recorded. This preresection distance should equal the postreconstruction distance to ensure limb length equality. A final mark was placed at the most anterior aspect of the femur to ensure proper femoral component rotation as the location of the linea aspera was not always exactly posterior.
After the femoral osteotomy, the proximal marrow was sent for frozen-section analysis to confirm a negative marrow margin. A trial tibial component was placed, and in all cases, an intraoperative radiograph was obtained to ensure placement perpendicular to the mechanical axis of the tibia. The trial hinge mechanism was reduced, and restoration of the preresection extremity length and rotation were verified using marks previously made on the proximal tibia and femur. The neurovascular bundle was palpated to ensure there was not excessive tension on the vessels, and a Doppler probe at the ankle confirmed the presence of the posterior tibial and dorsalis pedis pulses. We routinely used antibiotic-impregnated cement for all endoprosthetic reconstructions. The all-polyethylene tibial and patellar components were cemented first, followed by the femoral component separately. All patients were administered 100 mg Solu-Cortef® (Pfizer Inc, New York, NY) before placement of the femoral component, and the prosthesis was introduced slowly to avoid causing a fat embolism.
Before the introduction of the continuous passive motion (CPM) machine, patients initially were immobilized in a cast for 2 to 3 weeks before physical therapy. Since the introduction of the CPM machine in the early 1980s, all patients were placed into a CPM machine in the operating room. Motion was commenced from –5° extension to 30° to 45° flexion and gradually increased to greater than 90° flexion before discharge. A towel roll under the heel was used three times daily for 1 hour to ensure full extension was achieved. On the third postoperative day, patients were made weightbearing as tolerated with ambulatory supports and a knee immobilizer, which were used for 6 to 8 weeks. The CPM machine was used at home for 12 hours a day for 1 month to help ensure maximum flexion was achieved.
Patients were followed every 2 to 3 weeks for the first 2 months after surgery, then on a quarterly basis for 2 years, semiannually for an additional 2 years, and annually thereafter. Radiographs of the affected limb were obtained at each postoperative visit, along with quarterly chest radiographs and semiannual chest CT. Postoperative function was evaluated for each patient using the Musculoskeletal Tumor Society (MSTS) function score [23]. One hundred sixty of the 186 patients (86.0%) were available for functional evaluation and did not undergo amputation during the followup period.
Patient and prosthesis survival rates and 95% confidence intervals (CIs) were determined for all three groups using the Kaplan-Meier product-limit method [34]. Patient survival was analyzed using death attributable to disease progression as an end point. Prosthesis survivorship was determined for custom and modular implants separately using revision of the stemmed components for any reason as an end point. For purposes of implant survival, we did not include surgery attributable to failure of the bushings, the axle, or the metal tibial bearing component, all of which were managed successfully without the need for revision of major stemmed components. Implant and patient survival curves for the two types of implants and three grades or stages of malignancy were compared using the log-rank method [42]. Statistical analysis was performed using a commercially available statistics package (R, Version 2.9.0, The R Foundation for Statistical Computing, Vienna, Austria).
|
Survival |
5 years |
10 years |
15 years |
20 years |
25 years |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
% |
95% CI |
% |
95% CI |
% |
95% CI |
% |
95% CI |
% |
95% CI |
||||||
|
Lower |
Upper |
Lower |
Upper |
Lower |
Upper |
Lower |
Upper |
Lower |
Upper |
||||||
|
Implant survival |
|||||||||||||||
|
Low grade (n = 43) |
83.3% |
71.9% |
96.5% |
73.5% |
58.5% |
92.3% |
73.5% |
58.5% |
92.3% |
61.2% |
40.1% |
93.6% |
30.6% |
7.2% |
100.0% |
|
Stage IIA/IIB (n = 122) |
89.8% |
83.5% |
96.5% |
78.4% |
68.2% |
90.2% |
55.7% |
41.6% |
74.7% |
50.7% |
35.8% |
71.7% |
45.0% |
29.7% |
68.4% |
|
Stage III (n = 21) |
85.7% |
63.3% |
100.0% |
NA |
NA |
NA |
NA |
||||||||
|
Custom (n = 101) |
83.5% |
75.2% |
92.7% |
69.2% |
58.1% |
82.4% |
51.7% |
39.1% |
68.4% |
48.7% |
35.9% |
66.0% |
42.2% |
29.4% |
60.7% |
|
Modular (n = 85) |
93.7% |
87.9% |
99.9% |
93.7% |
87.9% |
99.9% |
93.7% |
87.9% |
99.9% |
NA |
NA |
||||
|
Overall (n = 186) |
87.7% |
82.2% |
93.7% |
77.2% |
68.7% |
86.7% |
61.6% |
50.1% |
75.7% |
57.9% |
45.6% |
73.5% |
50.2% |
36.8% |
68.5% |
|
Patient survival by diagnosis |
|||||||||||||||
|
Low grade (n = 43) |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
||||||||||
|
Stage IIA/IIB (n = 122) |
65.3% |
56.9% |
74.9% |
57.7% |
48.7% |
68.4% |
56.0% |
46.8% |
67.0% |
56.0% |
46.8% |
67.0% |
56.0% |
46.8% |
67.0% |
|
Stage III (n = 21) |
25.6% |
11.6% |
56.4% |
NA |
NA |
NA |
NA |
||||||||
|
Overall limb salvage |
91.3% |
86.7% |
96.3% |
89.0% |
83.5% |
94.8% |
85.2% |
77.9% |
93.1% |
78.8% |
68.6% |
90.6% |
78.8% |
68.6% |
90.6% |
Among the 160 patients for whom we had functional evaluations and who retained their implants, the mean postoperative MSTS score was 86.7% (mean score, 26.0; range, 11–29). The postoperative ROM on final assessment revealed mean flexion of 110.0° (range, 45°–140°), mean passive extension to 1.3° (range, 0°–40°), and mean active extension lag of 6.9° (range, 0°–120°). A postoperative flexion contracture was observed in seven patients, with a mean value of 10.0° (range, 5°–40°).
Historically, a debate existed among orthopaedic oncologists regarding which was the most durable method of reconstruction after distal femoral resection. Although high long-term implant survival and functional scores have been reported with a wide variety of reconstructive methods [5, 7, 14, 44, 53–55, 57, 65], our experience with osteoarticular allografts between 1975 and 1979 was poor, and in 1980 we abandoned this method of reconstruction in favor of a cemented endoprosthetic technique [13, 14, 51]. Recently, critics of this technique have cited high rates of aseptic loosening as the major reason for using alternative fixation methods [2, 38]. Such criticism does not consider the potential improvement in cemented implant survival over historical rates attributable to design modifications. We asked the following four questions: (1) Do newer implant designs perform better than older custom-designed implants? (2) Does tumor diagnosis influence implant survival? (3) What is the typical long-term functional result after distal femoral replacement? (4) What are the complications associated with endoprosthetic reconstruction of the distal femur?
The major limitations of this study are its retrospective design, the lack of a control group, and the lack of a prestudy power analysis. The first two limitations are difficult to overcome for numerous reasons. First, musculoskeletal tumors are rare, and although a prospective design certainly would enhance the validity of our conclusions, it would be exceedingly difficult to amass a large series of patients prospectively. Second, comparison to a control group is virtually impossible because other methods of reconstruction were used only rarely at our institution. In the absence of a prestudy power analysis, we have limited our conclusions to address the differences in survival rates and refrained from drawing conclusions when no difference was seen in the data. The questions addressed at the start of this paper will be addressed in light of these few but important limitations.
|
Study |
Year |
Number of patients |
Mean followup (years) |
Implant survivorship/revision ratea |
Mean MSTS scorea |
Amputationa |
Infectiona |
Local recurrencea |
|||
|---|---|---|---|---|---|---|---|---|---|---|---|
|
0–9 years |
10–14 years |
15–19 years |
≥ 20 years |
||||||||
|
Bradish et al. [4] |
1987 |
40 |
8 |
80.0% |
15E, 14G, 3F, 5Pb,c |
5.0% |
7.5% |
12.5% |
|||
|
Shih et al. [58] |
1993 |
61 |
2-6 |
0–42%g |
7E, 19G, 15F, 20Pb,c |
8.2% |
8.2% |
4.9% |
|||
|
Capannna et al. [8]d |
1994 |
95 |
4.3 |
75%e |
20E, 43G, 12F, 9Pb,c |
7.4% |
5.0% |
5.3% |
|||
|
Rougraff et al. [54]f |
1994 |
34 |
11 |
32.4%g |
76.7%h |
26.0% |
NA |
11.0% |
|||
|
Malawer and Chou [43]i |
1995 |
31 |
3.5j |
80.0% |
80.0% |
NAk |
12.9% |
19.4% |
0.0% |
||
|
Choong et al. [9] |
1996 |
32 |
3.5j |
6.7%g |
6E, 14G, 9F, 3Pb,c |
0.0% |
3.3% |
3.1% |
|||
|
Kawai et al. [35] |
1998 |
40 |
8j |
72.0% |
58.0% |
80.0% |
7.5% |
10.0% |
0.0% |
||
|
Malo et al. [44]l |
2001 |
56 |
3 |
NA |
80.4% |
NA |
NA |
NA |
|||
|
Bickels et al. [3] |
2002 |
110 |
7.8j |
93.0% |
88.0% |
94G/E, 9F, 7Pb,c |
3.6% |
5.4% |
5.4% |
||
|
Zeegen et al. [71]i |
2004 |
55 |
5 |
82%m |
NA |
NA |
NA |
NA |
|||
|
Torbert et al. [61]i |
2005 |
57 |
4.7 |
84.0% |
66.0% |
NA |
6.5% |
2.2% |
6.8% |
||
|
Frink et al. [26]n |
2005 |
83 |
12 |
86.0% |
86.0% |
86.0% |
88.0% |
NA |
NA |
2.3% |
|
|
Sharma et al. [57] |
2006 |
77 |
4.3 |
84.0% |
79.0% |
30b |
6.5% |
7.8% |
6.5% |
||
|
Schwab et al. [55]o |
2006 |
43 |
7.5 |
NA |
78.0% |
NA |
NA |
NA |
|||
|
Gosheger et al. [27]i |
2006 |
103 |
3.8 |
65.9% |
80.0% |
NA |
12.0% |
0.5% |
|||
|
Myers et al. [50]p |
2007 |
335 |
12 |
83.0% |
78.0% |
NA |
17.0% |
14.0% |
6.0% |
||
|
Jeys et al. [32]g,i |
2008 |
228 |
9j |
68.6% |
46.3% |
NA |
9.2% |
12.7% |
5.3% |
||
|
Current studyq |
2010 |
186 |
8 |
87.7% |
77.2% |
61.6% |
50.2% |
86.7% |
9.7% |
3.2% |
7.0% |
|
Date |
Implant design |
Manufacturer/features |
Tumor group (n = 186) |
|---|---|---|---|
|
1980–1990 |
Custom (JJE/JMK) |
Stryker/Howmedica |
73 |
|
Kinematic™ rotating hinge |
|||
|
Made of vitallium |
|||
|
Casted hollow body by lost-wax method |
|||
|
Welded Zickel nail stem |
|||
|
Extramedullary porous coating added in 1985 [61] |
|||
|
Techmedica |
28 |
||
|
All-titanium one piece |
|||
|
Noiles™ hinge |
|||
|
Total custom implants |
101 |
||
|
1990–2003 |
Modular |
Stryker/Howmedica |
53 |
|
Kinematic™ rotating hinge |
|||
|
Forged modular replacement system |
|||
|
Titanium segments |
|||
|
Extramedullary porous coating |
|||
|
Dow-Corning Wright |
2 |
||
|
Modular titanium |
|||
|
Lacey hinge |
|||
|
2003–2008 |
Modular |
Stryker Global Modular Replacement System |
30 |
|
Kinematic™ rotating hinge |
|||
|
Forged modular components |
|||
|
Titanium segments |
|||
|
Extramedullary porous coating |
|||
|
Larger axle and bushings |
|||
|
Press-fit stem option (none in this series) |
|||
|
Cobalt-chrome Morse taper |
|||
|
Total modular implants |
85 |
The functional scores were high for the majority of patients who underwent endoprosthetic distal femoral reconstructions (Table 3). Functional scores are assigned subjectively, and although newer scoring systems have attempted to eliminate subjective terminology, a precise and accurate measurement of function remains elusive. Despite these limitations, however, our results confirm the findings of previous studies, that favorable long-term function is possible after cemented distal femoral endoprosthetic reconstructions.
The most common local complications in our patients included mechanical failure, tumor recurrence, and infection. All 54 cases of mechanical failure (including modular and custom implants) were salvaged with revision to a larger stem, cross-stem fixation, or new components. Similar to findings described elsewhere, mechanical failures of this nature did not seem to compromise the overall limb salvage effort [59, 68]. Infection, however, worsened the prognosis. Five of 19 patients with wound-related complications that occurred after the index procedure required an amputation, and among an additional six patients who had a deep infection after a second or third procedure, four required an amputation. The total amputation rate in this series for all wound-related complications after either the index or revision procedure was nine of 25 (36.0%). We previously reported our preferred method of caring for patients with wound-related issues after endoprosthetic replacement [18]. Local recurrence portended a poor prognosis in this series as 61.5% of patients had died by the time of the most recent followup.
Our study reports the improved survival of cemented distal femoral endoprostheses during the past three decades. Contemporary modular forged implants performed better than the custom-designed prostheses of the 1970s and 1980s. Although failures may occur, mechanical complications can be revised and potentially outlast the original reconstruction. We recognize revision procedures will be necessary for patients with long-term life expectancy, and the need for continued improvement in reconstruction techniques and implant design, as high-grade disease-specific survival rates may continue to improve.










