The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 92, Issue 3

Scientific Articles | March 01, 2010

Comparison of Bone Mineral Density Between Porous Tantalum and Cemented Tibial Total Knee Arthroplasty Components

Yukihide Minoda, MD, PhD¹; Akio Kobayashi, MD, PhD¹; Hiroyoshi Iwaki, MD, PhD¹; Mitsuhiko Ikebuchi, MD¹; Fumiaki Inori, MD, PhD¹; Kunio Takaoka, MD, PhD¹

¹ Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka 545-8585, Japan. E-mail address for Y. Minoda: yminoda@msic.med.osaka-cu.ac.jp

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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

Investigation performed at the Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan

J Bone Joint Surg Am, 2010 Mar 01;92(3):700-706. doi: 10.2106/JBJS.H.01349

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Abstract

Background:

Porous tantalum was recently introduced as a metallic implant material for total knee arthroplasty. Its porosity, low modulus of elasticity, and high frictional characteristics were expected to provide physiologic load transfer and relative preservation of bone stock. However, to our knowledge, the effect of a Trabecular Metal tibial component on bone mineral density has not been reported. The purpose of the present study was to compare the periprosthetic bone mineral density between patients managed with uncemented Trabecular Metal and cemented tibial components.

Methods:

Twenty-eight knees receiving a Trabecular Metal tibial component and twenty-eight knees receiving a cemented cobalt-chromium tibial component had dual x-ray absorptiometry scans at two weeks preoperatively and at two weeks and six, twelve, eighteen, and twenty-four months postoperatively, to assess periprosthetic bone mineral density. All of the operations were performed by one surgeon through a medial parapatellar approach.

Results:

None of the differences between the two groups in terms of preoperative bone mineral density in the femoral neck, wrist, lumbar spine, or knee were significant. In both groups, the bone mineral density in the tibia decreased postoperatively. However, the postoperative decrease in bone mineral density in the lateral aspect of the tibia was significantly less in knees with Trabecular Metal components than in knees with cemented tibial components at twenty-four months (mean and standard deviation, -6.7% ± 22.9% compared with -36.8% ± 24.2%; p = 0.002). At twenty-four months postoperatively, there was no significant difference between the two groups in terms of the Knee Society score, range of motion of the knee, or bone mineral density in the lumbar spine. No prosthetic migration or periprosthetic fracture was detected in either group.

Conclusions:

The decrease in bone mineral density of the lateral tibial plateau was less in knees with a Trabecular Metal tibial component following total knee arthroplasty than in knees with a cemented tibial component. Additional research is needed to determine whether long-term clinical benefits are realized with the use of porous tantalum tibial components for total knee arthroplasty.

Level of Evidence:

Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Following total knee arthroplasty, bone mineral density decreases in the proximal part of the tibia^1-7. Stress-shielding is considered to be the major cause of this bone loss¹. Several studies have shown that the most pronounced reduction occurs during the first year after the operation^3,4,8. A strong correlation between bone mineral density and migration of the tibial component after total knee arthroplasty has been reported⁹. The tibial component exhibits less migration in knees with higher bone mineral density⁹. Cementless components have been expected to reduce bone loss after total knee arthroplasty in comparison with cemented components. However, previous studies have revealed that conventional cementless tibial components, even with a hydroxyapatite coating, did not reduce bone mineral density loss in the proximal part of the tibia after total knee arthroplasty when compared with cemented tibial components^2,4,5.

The introduction of porous tantalum metal (Trabecular Metal; Zimmer, Warsaw, Indiana) for acetabular component fixation during total hip arthroplasty has yielded theoretically better fixation qualities and a so-called "gap filling" effect^10-12. It has been reported that the high volumetric porosity (70% to 80%), low modulus of elasticity (3 MPa), and high friction characteristics of Trabecular Metal make it conducive to biologic fixation¹². Recently, Trabecular Metal was introduced as a material in the tibial component of a total knee prosthesis. However, to our knowledge, the effects of this new material on the change in bone mineral density in the proximal part of the tibia have not been reported. We hypothesized that cementless fixation with use of a Trabecular Metal tibial component would lessen the postoperative decrease in bone mineral density in the proximal part of the tibia following total knee arthroplasty in comparison with that associated with the use of a cemented tibial component.

Materials and Methods

From June 2004 to September 2005, thirty-two primary total knee arthroplasties were performed in thirty-two patients with a Trabecular Metal tibial component and a cemented cobalt-chromium femoral component (NexGen LPS-Flex; Zimmer). Three patients (three treated knees) died of causes unrelated to the surgery during the follow-up period. One patient (one treated knee) did not undergo bone mineral density measurement at two weeks after the operation. The results of both clinical and radiographic evaluations throughout the two-year period following the operation were available for the remaining twenty-eight patients (twenty-eight treated knees). In the computerized database at our institution, seventy-six patients who underwent primary total knee arthroplasty with a cemented cobalt-chromium-alloy tibial component (P.F.C. Sigma RP; DePuy, Warsaw, Indiana) during the same general time period were identified. Matched pairs of patients were formed with respect to sex, age, body weight, height, diagnosis, and date of surgery. Bone mineral density in the proximal part of the tibia was compared between knees with a cementless Trabecular Metal tibial component and those with a cemented tibial component. The study was approved by our institutional review board, and all patients provided informed consent for participation in the study.

All of the total knee arthroplasties were performed by one author (A.K.) through a standard midline skin incision measuring 10 to 15 cm in length and with use of a medial parapatellar approach. The posterior cruciate ligament was resected. The size of the femoral component was determined with use of a sizer with an anterior reference system. Rotation of the femoral component was set at 3° of external rotation with respect to the posterior aspect of the femoral condyles. Ligamentous balancing was then performed. After pulsed lavage, all femoral components were inserted with cement. The tibial components were inserted without cement in the Trabecular Metal tibial component group and were inserted with cement in the cemented tibial component group. The day after the operation, the patient was allowed to walk. Comorbidity was assessed from the clinical records. The Knee Society score¹³ and the range of motion of the knee¹⁴ were measured preoperatively and twenty-four months postoperatively by one author (Y.M.) who was not involved with any of the procedures.

Dual x-ray absorptiometry was used to measure the bone mineral density^15,16. The Hologic dual x-ray absorptiometry system (QDR 4500A; Hologic, Bedford, Massachusetts) was used in the present study. Standard dual x-ray absorptiometry scans of the lumbar spine (L2 to L4), the ipsilateral hip (femoral neck), and the ipsilateral forearm were made preoperatively. Standard dual x-ray absorptiometry scans of the lumbar spine were also made twenty-four months after the operation. The density in the proximal part of the tibia was measured at two weeks preoperatively and at two weeks and six, twelve, eighteen, and twenty-four months postoperatively. The proximal part of the tibia was divided into three regions of interest: the medial region (Region 1), the central region (Region 2), and the lateral region (Region 3) (Figs. 1-A and 1-B). The relative change in the bone mineral density in Regions 1, 2, and 3 was defined as the ratio of bone mineral density between two weeks postoperatively and each postoperative measurement period (six, twelve, eighteen, and twenty-four months). For fifteen patients, the dual x-ray absorptiometry measurements were repeated with an interval of one to seven days to evaluate reproducibility.

Fig. 1-A Fig. 1-B

Bone mineral density measurement in the proximal part of the tibia was performed in the anteroposterior projection for the Trabecular Metal group (Fig. 1-A) and the cemented tibial component group (Fig. 1-B). Region 1 (the medial region) is 1 cm distal to the tibial baseplate within the medial cortex of the proximal part of the tibia, Region 2 (the central region) is 4 cm distal to the tibial baseplate in the center of the tibia, and Region 3 (the lateral region) is 1 cm distal to the tibial baseplate within the lateral cortex of the proximal part of the tibia. Each region of interest is a 1-cm square.

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Statistical Analysis

Age, body weight, height, preoperative and postoperative Knee Society scores¹³, and preoperative bone mineral density in the lumbar spine, hip, forearm, and knee were compared between the two groups with use of the Mann-Whitney U test. Sex, preoperative diagnosis, and comorbidity were compared between the two groups with use of the chi-square test or the Fisher exact test. The relative change in bone mineral density at six, twelve, eighteen, and twenty-four months was compared between the two groups in each stratum with use of the Mann-Whitney U test. The bone mineral density in each region of interest at two weeks after the operation and at the time of follow-up (six, twelve, eighteen, and twenty-four months after the operation) were compared with use of the paired t test. P values of <0.05 were considered significant for the Mann-Whitney U test, chi-square test, Fisher exact test, and paired t test. A power analysis for relative change in bone mineral density revealed that a sample size of twenty would be required to establish significance with a difference of 22%, an a of 0.05, and a power of 0.8.

Source of Funding

There was no external source of funding for the present study.

Results

The mean absolute value of the difference in the dual x-ray absorptiometry between two repeated measurements was 0.018 g/cm² (95% confidence limits, —0.002 and 0.037 g/cm²) in Region 1 (the medial region), 0.020 g/cm² (95% confidence limits, —0.005 and 0.053 g/cm²) in Region 2 (the central region), and 0.042 g/cm² (95% confidence limits, —0.011 and 0.096 g/cm²) in Region 3 (the lateral region). The interclass correlation coefficients were 0.998, 0.995, and 0.991 for Regions 1, 2, and 3, respectively.

From the cohort of seventy-six patients who underwent primary total knee arthroplasty with a cemented cobalt-chromium-alloy tibial component, twenty-eight patients (twenty-eight knees) were matched to patients who received a Trabecular Metal tibial component.

None of the differences between the two groups in terms of preoperative demographic data (age, sex, body weight, height, diagnosis, Knee Society score, and range of motion), comorbidities, or preoperative bone mineral densities (lumbar spine, hip, forearm, and knee) were significant (Table I). At twenty-four months postoperatively, the differences between the two groups in terms of the Knee Society score, the range of motion of the knee, and bone mineral density in the lumbar spine were not significant (Table II). No prosthetic migration or periprosthetic fracture was detected during the follow-up period.

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TABLE I Preoperative Parameters

Parameters	Trabecular Metal Group (N = 28)	Cemented Tibial Component Group (N = 28)	P Value
Age at the time of the operation*(yr)	74.1 ± 6.7	71.6 ± 6.7	0.136
Male:female ratio (no. of patients)	6:22	6:22	>0.999
Body weight*(kg)	55.6 ± 10.6	59.1 ± 9.1	0.198
Height*(cm)	149.6 ± 8.2	151.8 ± 7.9	0.255
Diagnosis (osteoarthritis:rheumatoid arthritis) (no. of patients)	26:2	26:2	>0.999
Comorbidity (no. of patients)
Cerebrovascular disease	2 (7.1%)	3 (10.7%)	>0.999
Chronic pulmonary disease	1 (3.6%)	2 (7.1%)	>0.999
Congestive heart failure	1 (3.6%)	0 (0%)	>0.999
Diabetes (without chronic complication)	3 (10.7%)	5 (17.9%)	0.705
Old myocardial infarction	2 (7.1%)	1 (3.6%)	>0.999
Knee Society score*(points)
Knee	37.6 ± 7.5	40.6 ± 9.9	0.186
Function	43.5 ± 10.1	44.3 ± 11.3	0.094
Range of motion of the knee*(deg)
Extension	-10.5 ± 6.3	-11.6 ± 11.5	0.518
Flexion	120.5 ± 13.8	121.4 ± 14.3	0.682
Bone mineral density*(g/cm2)
Lumbar spine	0.937 ± 0.199	0.874 ± 0.120	0.359
Hip	0.746 ± 0.146	0.772 ± 0.122	0.579
Forearm	0.445 ± 0.063	0.433 ± 0.058	0.533
Knee
Region 1	0.821 ± 0.253	0.759 ± 0.275	0.284
Region 2	0.611 ± 0.168	0.566 ± 0.213	0.426
Region 3	0.500 ± 0.152	0.510 ± 0.145	0.849

*The values are given as the mean and the standard deviation.

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TABLE I Preoperative Parameters

Parameters	Trabecular Metal Group (N = 28)	Cemented Tibial Component Group (N = 28)	P Value
Age at the time of the operation*(yr)	74.1 ± 6.7	71.6 ± 6.7	0.136
Male:female ratio (no. of patients)	6:22	6:22	>0.999
Body weight*(kg)	55.6 ± 10.6	59.1 ± 9.1	0.198
Height*(cm)	149.6 ± 8.2	151.8 ± 7.9	0.255
Diagnosis (osteoarthritis:rheumatoid arthritis) (no. of patients)	26:2	26:2	>0.999
Comorbidity (no. of patients)
Cerebrovascular disease	2 (7.1%)	3 (10.7%)	>0.999
Chronic pulmonary disease	1 (3.6%)	2 (7.1%)	>0.999
Congestive heart failure	1 (3.6%)	0 (0%)	>0.999
Diabetes (without chronic complication)	3 (10.7%)	5 (17.9%)	0.705
Old myocardial infarction	2 (7.1%)	1 (3.6%)	>0.999
Knee Society score*(points)
Knee	37.6 ± 7.5	40.6 ± 9.9	0.186
Function	43.5 ± 10.1	44.3 ± 11.3	0.094
Range of motion of the knee*(deg)
Extension	-10.5 ± 6.3	-11.6 ± 11.5	0.518
Flexion	120.5 ± 13.8	121.4 ± 14.3	0.682
Bone mineral density*(g/cm2)
Lumbar spine	0.937 ± 0.199	0.874 ± 0.120	0.359
Hip	0.746 ± 0.146	0.772 ± 0.122	0.579
Forearm	0.445 ± 0.063	0.433 ± 0.058	0.533
Knee
Region 1	0.821 ± 0.253	0.759 ± 0.275	0.284
Region 2	0.611 ± 0.168	0.566 ± 0.213	0.426
Region 3	0.500 ± 0.152	0.510 ± 0.145	0.849

*The values are given as the mean and the standard deviation.

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TABLE II Postoperative Parameters at Twenty-four Months

Parameters	Trabecular Metal Group* (N = 28)	Cemented Tibial Component Group* (N = 28)	P Value†
Knee Society score (points)
Knee	95.8 ± 6.4	93.8 ± 3.3	0.144
Function	80.1 ± 14.9	86.3 ± 12.0	0.114
Range of motion of the knee (deg)
Extension	—2.0 ± 3.4	—2.5 ± 6.2	0.857
Flexion	125.0 ± 10.0	125.5 ± 11.1	0.676
Bone mineral density (g/cm2)
Lumbar spine	0.881 ± 0.113	0.946 ± 0.210	0.903

*The values are given as the mean and the standard deviation.
†Mann-Whitney U test.

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TABLE II Postoperative Parameters at Twenty-four Months

Parameters	Trabecular Metal Group* (N = 28)	Cemented Tibial Component Group* (N = 28)	P Value†
Knee Society score (points)
Knee	95.8 ± 6.4	93.8 ± 3.3	0.144
Function	80.1 ± 14.9	86.3 ± 12.0	0.114
Range of motion of the knee (deg)
Extension	—2.0 ± 3.4	—2.5 ± 6.2	0.857
Flexion	125.0 ± 10.0	125.5 ± 11.1	0.676
Bone mineral density (g/cm2)
Lumbar spine	0.881 ± 0.113	0.946 ± 0.210	0.903

*The values are given as the mean and the standard deviation.
†Mann-Whitney U test.

The bone mineral density in Region 1 (the medial region) was significantly decreased at six, twelve, eighteen, and twenty-four months in both groups (p < 0.001). The bone mineral density in Region 2 (the central region) was significantly decreased at six, twelve, eighteen, and twenty-four months in both groups (p = 0.009 at six months, p = 0.012 at twelve months, p = 0.019 at eighteen months, and p = 0.017 at twenty-four months in the Trabecular Metal group, and p = 0.049 at six months, p = 0.019 at eighteen months, and p = 0.002 at twenty-four months in the cemented tibial component group), with the exception of that at twelve months in the cemented tibial component group (p = 0.069). The bone mineral density in Region 3 (the lateral region) was significantly decreased at six, twelve, eighteen, and twenty-four months in the cemented tibial component group (p < 0.001). However, the bone mineral density in Region 3 was not decreased significantly in the Trabecular Metal group (see Appendix). The relative change in bone mineral density in Region 1 (and standard deviation) at twenty-four months was —41.3% ± 19.5% in the Trabecular Metal group and —38.6% ± 23.3% in the cemented tibial component group. The relative change in bone mineral density in Region 2 at twenty-four months was —7.9% ± 25.7% in the Trabecular Metal group and —13.8% ± 26.1% in the cemented tibial component group. The relative change in bone mineral density in Region 3 at twenty-four months was —6.7% ± 22.9% in the Trabecular Metal group and —36.8% ± 24.2% in the cemented tibial component group (Figs. 2-A, 2-B, and 2-C). The differences between the groups in terms of the relative change in bone mineral density in Regions 1 and 2 were not significant. However, the decrease in relative bone mineral density in the lateral aspect of the tibia (Region 3) was significantly less with the Trabecular Metal component than with the cemented tibial component (p = 0.0002 at six months, p = 0.007 at twelve months, p = 0.003 at eighteen months, and p = 0.002 at twenty-four months) (see Appendix).

Fig. 2-A Fig. 2-B Fig. 2-C

Figs. 2-A, 2-B, and 2-C Graphs illustrating the relative change in bone mineral density (BMD) in regions of interest (ROI) 1, 2, and 3 in the proximal part of the tibia. The mean and the standard deviation are shown. The black dots represent the Trabecular Metal component group, and the white dots represent the cemented tibial component group. Figs. 2-A and 2-B The difference in the relative change in bone mineral density between groups was not significant in Region 1 or 2. Fig. 2-C The relative change in bone mineral density in Region 3 was significantly less with the Trabecular Metal component than with the cemented tibial component. *p < 0.05.

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Discussion

It has been reported that bone mineral density and migration of the tibial component after total knee arthroplasty are strongly correlated⁹. Less migration of the tibial component has been observed in knees with higher bone mineral density⁹. Previous studies have demonstrated a decrease in bone mineral density in the proximal part of the tibia after total knee arthroplasty^1-7. The decrease in bone mineral density is most obvious during the first six months, with a magnitude of decrease of as high as 23%¹. This decrease remains substantial, with an average of 5% per year, for as long as two years after total knee arthroplasty^3,7,15-17. In the present study, the bone mineral density in Region 1 (the medial region) at twenty-four months postoperatively decreased by 38.6% (range, —73.2% to 52.6%) in the cemented tibial component group and by 41.3% (—72.9% to 11.4%) in the Trabecular Metal group. No prosthetic migration or periprosthetic fracture was detected during the follow-up period in the present study.

Since 1999, porous tantalum has been applied to primary total knee arthroplasty implants. We expected that the characteristics of Trabecular Metal, which increase initial stability and accelerate bone ingrowth¹⁸, would improve the postoperative change in bone mineral density in the proximal part of the tibia after total knee arthroplasty. To our knowledge, however, the effect of Trabecular Metal on bone mineral density after total knee arthroplasty has not been previously determined. In the present study, the bone mineral density in the lateral aspect of the tibia (Region 3) was not significantly decreased postoperatively with use of a Trabecular Metal tibial component, and the decrease in relative bone mineral density in this area was significantly less in the group treated with the Trabecular Metal component than in the group treated with the cemented tibial component. It has been reported that conventional non-Trabecular-Metal cementless tibial components, even with hydroxyapatite coating, did not decrease bone mineral density loss in the proximal part of the tibia in comparison with cemented tibial components^2,4,5. The difference in bone mineral density in the proximal part of the tibia might be due to the differences in fixation and load transmission patterns between Trabecular Metal and conventional cementless tibial components. Our dual x-ray absorptiometry findings showed that the Trabecular Metal tibial component had a favorable effect on bone mineral density in the proximal lateral part of the tibia after total knee arthroplasty.

We did not find a significant difference in the relative change in bone mineral density in Region 1 (the medial region) or Region 2 (the central region) at any measurement period between the Trabecular Metal and cemented tibial component groups. The medial peg of the tibial component nearly touched the medial tibial cortex in nine (32%) of the twenty-eight knees in the Trabecular Metal group. We suspect that this resulted in some stress-shielding of the medial tibial plateau (Region 1) and that this stress-shielding may have offset the effect of the Trabecular Metal in this region. Region 2 (the central region) was more distal from the baseplate of the tibial component than the other two regions were. Therefore, the bone mineral density in Region 2 may have been more influenced by the difference in patient characteristics such as activity level, age, sex, or the existence of osteoporosis rather than by the tibial component itself. We suspect that these patient characteristics, which were not significantly different between the two groups, resulted in the nonsignificant difference in bone mineral density change in Region 2.

The present study had several limitations. First, the relationship between the bone mineral density around the tibial component and clinical results such as the Knee Society score, radiolucent lines, loosening, and periprosthetic fracture has yet to be determined. Although the Trabecular Metal group had less postoperative bone mineral density loss in the lateral tibial plateau than did the cemented tibial component group, there was no difference between the two groups in terms of clinical results. Our short-term follow-up period and good clinical results in both groups may be responsible for this finding. We suspect that the prevention of a decrease in bone mineral density around the tibial component may be more advantageous in cases of revision performed because of loosening and periprosthetic fracture. Second, the difference between the Trabecular Metal group and the cemented tibial component group was not only the fixation method but also the material and design of the tibial component. The tibial component in the cemented tibial component group had a baseplate with a cemented stem. In contrast, the tibial component in the Trabecular Metal group had two small pegs and a different shape. Third, the use of cement may have influenced the postoperative bone mineral density in the cemented tibial component group. Interestingly, the cemented tibial component group had higher bone mineral density values at two weeks after the operation than the Trabecular Metal group did. Fourth, the femoral components in the two groups were produced by different manufacturers. However, the material of both femoral components was cobalt-chromium alloy, and both designs were posterior stabilized types. Saari et al. reported that the femoral component design did not influence postoperative bone mineral density changes around the tibial component¹. Therefore, we assumed that the differences between the two groups in terms of the femoral component had a minimal influence on our results.

The present study suggests that the porous tantalum tibial component has a beneficial effect with regard to maintaining more periprosthetic bone mineral density in the lateral tibial plateau as compared with a conventional cemented tibial component. However, there was no difference between the two groups in terms of the Knee Society score, postoperative complications, or radiographic results. The clinical benefits of porous tantalum for the tibial component remain unproven. Additional research is needed to determine whether long-term clinical benefits are realized in association with the use of porous tantalum in total knee arthroplasty.

Appendix

Tables showing the bone mineral density values and the relative change in bone mineral density in the different regions are available with the electronic version of this article on our web site at jbjs.org (go to the article citation and click on "Supporting Data").

Acknowledgements

Note: The authors thank Yusuke Hashimoto, MD, PhD, and Katsuaki Tanaka, MD, PhD, for their assistance with this study.

References

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Topics

bone mineral density ; knee joint ; metals ; tantalum ; tibia ; knee replacement arthroplasty

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Yukihide Minoda, Akio Kobayashi, Hiroyoshi Iwaki, Mitsuhiko Ikebuchi, Fumiaki Inori, Kunio Takaoka; Comparison of Bone Mineral Density Between Porous Tantalum and Cemented Tibial Total Knee Arthroplasty Components. The Journal of Bone & Joint Surgery. 2010 Mar;92(3):700-706.

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