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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 146 - 146
1 Dec 2013
Padgett DE Dounchis J Bragdon CR Elson L Malchau H
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Introduction:

Acetabular component orientation has been linked to hip stability as well as bearing mechanics such as wear. Previous studies have demonstrated wide variations of cup placement in hip arthroplasty using conventional implantation techniques which rely upon either anatomic landmarks or the use of commercial positioning guides. Enabling technologies such as navigation have been used to improve precision and accuracy. Newer technologies such as robotic guidance have been postulated to further improve accuracy. The goal of our study was to evaluate the clinical reproducibility of a consecutive series of haptically guided THR.

Methods:

119 patients at 4 centers were enrolled. All patients had preoperative CT scans for the purpose of planning cup placement in lateral opening and version using proprietary software (Mako, Ft. Lauderdale, FL). All procedures were performed using a posterolateral approach. Following bone registration, acetabular preparation and component position is performed using haptic guidance. Final implant postion is ascertained by obtaining 5 points about the rim of the acetabular component and recorded. At 6 weeks, all patients had AP and cross-table lateral radiographs which were then analyzed for cup abduction and anteversion using the Hip Analysis Suite software. The goal was to determine the variability between desired preoperative plan, intraoperative measurement and postoperative results.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 234 - 234
1 Dec 2013
Barr C Nebergall A Scarborough D Braithwaite G Kwon Y Rubash HE Muratoglu O Malchau H
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Introduction:

Acetabular cup position is an important factor in successful total hip arthroplasty (THA). Optimal cup placement requires surgeons to possess an accurate perception of pelvic orientation during cup impaction, however, varying pelvic anatomy and limited visual cues in the surgical field may interfere with this process. The purpose of this study was to evaluate the utility of an inertial measurement unit (IMU) in monitoring pelvic position during THA.

Materials & Methods:

Ten patients scheduled to undergo THA were IRB-approved and consented by four surgeons. A small IMU was placed over the patient's sacrum pre-operatively and zeroed in standing position. Pelvic orientation data was streamed and captured wirelessly throughout the procedure. Surgeons were blinded to all data throughout the study period. Prior to cup impaction, the surgeon indicated his intended cup abduction angle and the degree to which the cup impactor was manipulated to compensate for perceived AP pelvic tilt. The degree of pelvic tilt as determined by the IMU (angle β) was then recorded (Figure 1). AP-pelvis radiographs were measured in Martell Hip Analysis Suite post-operatively to calculate the cup abduction angle, which was then compared to the surgeon's intended abduction angle to determine surgeon accuracy. To predict the final cup abduction angle, the degree of pelvic tilt recorded by the IMU (angle β) was subtracted from the abduction angle of the cup impactor (angle α) that was positioned using the OR table as a reference (Figure 1). This value was then compared to the measured post-operative cup abduction angle in order to assess the accuracy of the IMU in measuring pelvic tilt. Surgeon accuracy and IMU accuracy were compared to determine if the IMU was more or less effective than surgeon perception at determining pelvic tilt.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 606 - 606
1 Dec 2013
Zumbrunn T Varadarajan KM Duffy M Rubash HE Malchau H Freiberg A Muratoglu O
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INTRODUCTION

Femoral head diameter has a major influence on stability and dislocation resistance after Total Hip Arthroplasty (THA). Although routine use of large heads is common, several recent studies have shown that contemporary large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas which wraps around the femoral head, leading to refractory anterior hip pain. To address this, we developed a novel Anatomically Contoured large diameter femoral Head (ACH). We hypothesized that anatomical contouring of the ACH implant for soft tissue relief would not compromise dislocation resistance, and the ACH implant would provide increased stability compared to small heads.

METHODS

In this study the dislocation resistance of a 36 mm ACH was compared to that of 28 mm and 36 mm contemporary heads. The ACH implant was based on a 36 mm sphere with smaller radii used to contour the peripheral region below the equator of the head. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 1). Impingement-free motion (motion without neck impingement against the acetabular liner) and jump distance (head separation from acetabulum prior to dislocation) were measured to evaluate the dislocation risk of each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 1 - 1
1 Aug 2013
Dounchis J Elson L Bragdon CR Padgett D Illgen M Malchau H
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Introduction

In total hip arthroplasty, the positioning of the acetabular cup, in particular, has been shown to play an important role in the survivorship of the prosthetic joint. The commonly accepted “safe zone” extends from 5–30° of anteversion to 30–50° of inclination. However, several studies have utilized a more restrictive safe zone of 5–25° of anteversion and 30–45° of inclination, a modification of the Lewinnek zone. Many attempts have been made to develop a more reliable method of positioning the acetabular component. Robotic-assisted surgery is one such method. The purpose of this study was to compare the resulting position of the acetabular component after robotic-assisted surgery with the intraoperative robotic data to determine if improved accuracy can be achieved with the robotic-assisted method.

Methods

One hundred and nineteen patients received THA, at four different medical centers in the United States, using a haptic robotic arm. Pre-operative CT scans were obtained for all patients and used during the planning of the procedure, at which point the proposed component size and positioning was determined. Preparation of the acetabular bone bed, as well as impaction of the acetabular component itself, was performed using the robotic device.

Using an AP Pelvis and Cross-Table Lateral radiograph, each patient's resulting acetabular inclination and version was measured using the Hip Analysis Suite software. The component position retrieved from the robot was compared to the measured values from the radiographs. The positioning data was compared to two safe zones described above.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 243 - 243
1 Sep 2012
Bragdon C Malchau H Greene M Doerner M Emerson R Gebuhr P Huddleston J Cimbrelo E
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Introduction

Proper cup positioning is a critical component in the success of total hip arthroplasty surgery. A multicenter study has been initiated to study a new type of highly cross-linked polyethylene. This study provides a unique opportunity to a review the acetabular cup placement of over 500 patients implanted in the past 2 years from 13 medical centers from the U.S., Mexico, and Europe.

Methods

482 patients have received primary total hip arthroplasty using components from a single manufacturer in 5 centers in the US and Mexico and 7 centers in Europe. The acetabular anteversion and inclination were measured in post-operative radiographs. An acceptable window of cup position is defined at 5–25° of anteversion and 30–45° of inclination.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 289 - 289
1 Sep 2012
Bragdon C Martell J Jarrett B Clohisy J White R Goldberg V Della Valle C Berry D Johanson P Harris W Malchau H
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Introduction

Total hip replacements using highly cross-linked polyethylene show excellent clinical outcomes, low wear, and minimal lysis at 5 years follow-up. A recent RSA study reports a significant increase in femoral head penetration between 5 and 7 years. This study is a multi-center radiographic analysis to determine whether the RSA observation is present in a large patient cohort.

Methods

Six centers were enrolled for radiographic analysis of primary total hip arthroplasty for standard head sizes (26mm, 28mm, or 32mm). Radiographic inclusion criteria required a minimum of four films per patient at the following time points: 1 year; 2–4.5 years; 4.5–5.5 years; and 5.5–11 years. The Martell Hip Analysis Suite was used to analyze pelvic radiographs resulting in head penetration values. Wear rates were determined in two ways: the longest follow-up radiograph compared to the 1 year film, and individual linear regressions for the early and late periods. For both methods, average wear rates from the early period (1 to 5.5 years) and late period (>5.5 years) were compared using t-tests.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 539 - 539
1 Sep 2012
Bragdon C Doerner M Callanan M Zurakowski D Kwon Y Rubash H Malchau H
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Introduction

Acetabular cup positioning has been linked to dislocation and increased bearing surface wear. A previous study found correlations between patient and surgical factors and acetabular component position. The purpose of this study was to determine if acetabular cup positioning improves when surgeons receive feedback on their performance.

Methods

Post-op anteroposterior (AP) pelvis and cross-table lateral radiographs were previously obtained for 2061 patients who received a total hip arthroplasty (THA) or hip resurfacing from 2004–2008. The surgeries were performed by 7 surgeons. AP radiographs were measured using Hip Analysis Suite to calculate the cup inclination and version angles. Acceptable ranges were defined for abduction (30–45 °) and version (5–25 °). The same surgeons performed a THA or hip resurfacing on 385 patients from January 2009 through June 2010. Cup inclination and version angles for this set of surgeries were compared to surgeries from 2004–2008 to determine if cup inclination and version angles improved in response to previous acetabular cup positioning studies. Improvement in accuracy was assessed by the chi-square test.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 575 - 575
1 Nov 2011
Marchie A Callanan M Bragdon C Zurakowski D Malchau H
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Purpose: The purpose of this study was to determine if correlation exists between acetabular cup positioning and factors relating to the surgeon and patient.

Method: Data for 2063 patients who underwent primary or revision THA from 2004 – 2008 were compiled. The post-op anteroposterior (AP) and cross-table lateral digital radiographs for each patient were obtained. The AP radiograph was measured using Hip Analysis Suite to calculate the cup abduction and version angles (version direction determined separately). Acceptable ranges were 35–45° for abduction, and 5–20° for version. Correlations were then determined with SPSS™ software.

Results: There were 1980(96%) qualifying patients. There were 1025(52%) acetabular cups that fell within the 35–45° abduction range, and 1287(70%) cups in the 5–20° version range. Regression analysis showed that the only independent predictor of acceptable abduction angle was the surgical approach (p< 0.001). Posterolateral approach was the most accurate (57% acceptability). In contrast to the posterolateral, the MIS (2 incision) approach was 3 times (95%C.I. 1.5–5, p=0.001), and the mini anterolateral approach 2.5 times (95%C.I. 1–6.5, p=0.035) more likely to have unacceptable abduction angles. The only independent predictor of acceptable version was the performing surgeon (p< 0.001), with higher volume surgeons showing greater accuracy.

Conclusion: The posterolateral approach was superior to MIS (2 incision) and mini anterolateral approaches for acceptable abduction angle, and surgeon volume influenced version angle acceptability. Further analysis on variables and their influence on cup position at a lower volume medical center would provide a valuable comparison.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 223 - 223
1 May 2011
Wannomae K Rowell S Micheli B Malchau H Muratoglu O
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Radiation crosslinking decreases the wear of ultra-high molecular weight polyethylene (UHMWPE) and subsequent heating increases its oxidative stability. Clinical trials are showing lower femoral head penetration rate with highly crosslinked vs. conventional UHMWPE liners. Recently, a follow-up report showed a surprising increase in the femoral head penetration rate with a highly crosslinked UHMWPE, prompting us to closely analyze surgically explanted highly crosslinked UHMWPEs.

Thirty-four highly crosslinked components, all irradiated (100kGy) and melted, were included in the study. The components were surgically removed from patients for non-polyethylene related reasons. Oxidation was determined at the rim immediately after explantation. After shelf storage in air for 5–77 months, oxidation and crosslink density were measured at the rim and articular surfaces. An additional retrieval (92 mos. in vivo) was tested on the hip simulator; oxidation and crosslink density were determined after simulator testing.

All components showed no detectable oxidation immediately after explantation; however, surprisingly oxidation levels increased during shelf storage. Areas with increased oxidation showed a decrease in crosslink density. These changes did not correlate with in vivo duration; however, they correlated strongly with ex vivo duration. The component subjected to hip simulator testing showed no measurable wear and showed no detectable oxidation or marked decrease in crosslink density.

Two mechanisms may have reduced the oxidation resistance of highly crosslinked UHMWPE upon exposure to in vivo elements and subsequent exposure to air. One mechanism is based on free radical formation during cyclic loading; the other is based on an oxidation cascade initiated by absorbed lipids. Further studies are necessary to determine the impact of these mechanisms, if any, on the stability of components during in vivo service.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 88 - 89
1 May 2011
Malchau H Callanan M Bragdon C Zurakowski D Jarrett B Rubash H
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There are a variety of patient and surgical factors shown to increase post-operative complication risk for a total hip arthroplasty (THA). While many studies have linked patient and surgical factors to unsuccessful outcomes post total hip arthroplasty (THA), no study has attempted to correlate the infiuence of these factors to the positioning of the acetabular cup. The purpose of this study was to determine if a correlation exists between patient and surgical factors and the anatomical position of the acetabular component.

Data for 2063 patients from 2004–2008 who underwent a primary total hip arthroplasty (THA), revision THA, or Birmingham Hip Resurfacing procedure was compiled. The post- op anteroposterior pelvis (AP) and the cross table lateral digital radiographs for each patient were measured to determine cup inclination and version. Acceptable angle ranges were defined as 30–45° for abduction, and 5–25° for version. Correlations between variables and cup abduction and version angles were determined with SPSS™ statistical software.

There were 1954(95%) qualifying patients. There were 1218(62%) acetabular cups that fell within the 30–45° optimal abduction range, and 1576(87%) cups in the 5–25° optimal version range. There were 921(47%) patients that had both inclination and version angles that fell within the optimal range. Regression analysis showed that surgical approach (p> 0.001), high/low volume surgeon (p< 0.001), and obesity (BMI > 30, p=0.01) were independent predictors for abduction and version combined analysis. Both surgical approach (p< 0.001) and BMI (p=0.018) were independent predictors in the individual analysis of both abduction and version. High/low volume surgeon was significant for the independent analysis of abduction (p=0.013). In the combined analysis, low volume surgeons showed a 2 fold increase (95% C.I. 1.5–2.8) in risk for cup malpositioning compared to high volume surgeons. The MIS surgical approach showed a 6 fold increase (95% C.I. 3.5–10.7) in risk for cup malpositioning compared to the posterolateral approach. Obesity (BMI> 30) showed a 1.3 fold increase (95% C.I. 1.1–1.7) in risk for cup malpositioning compared to all other body mass index groups.

Posterolateral surgical approach was superior to MIS surgical approaches for independent and combined abduction and version analysis. High volume surgeons had greater accuracy for cup positioning, specifically for achieving optimal cup abduction angle. Compared to all other body mass index categories, patients that were obese (BMI> 30) displayed a greater risk for cup malpositioning for independent and combined abduction and version analysis. Further statistical analyses on patient and surgical variables and their infiuence on cup position at a lower volume medical center would provide a valuable data comparison.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 126 - 126
1 May 2011
Bragdon C Martell J Clohisy J White R Goldberg V Della Valla C Berry D Jarrett B Harris W Malchau H
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Studies of patients having primary THR using highly cross-linked polyethylene show excellent clinical outcomes and very low radiographic wear results at a minimum of 5 years follow-up. Recently, a radiostereometric analysis (RSA) study of a small group of patients reported that after no detectable wear during years 1–5, they found a significant increase in femoral head penetration between 5 and 7 years follow-up. However, this increase in head penetration after 5 years has not been confirmed in a larger patient cohort.

The purpose of this study was to organize a multicenter radiographic study involving leading medical centers in the U.S. having the longest-term follow-up available on this type of highly cross-linked polyethylene in order to determine if the RSA observation can be confirmed in a larger study.

Six academic centers agreed to contribute radiographic data to this study. All patients received primary total hip replacements with Longevity polyethylene liners (Zimmer, Warsaw, IN) coupled with 26, 28, and 32mm cobalt chrome femoral heads. The radiographic inclusion criteria required a minimum of four radiographs per patient: one at 1 year; at least one from 2 to 4.5 years; one 4.5 to 5.5 years; and at least one from 5.5 to 9 years follow-up. The Martell Hip Analysis Suit-eTM software was used for the wear analysis. All wear values were determined by calculating head penetration between the follow-up radiograph and the 1-year radiograph to remove creep, the majority of which has been shown to occur during the first year. Separate linear regressions, representing the wear rates, were computed for the early period from 1 year to 5.5 years and the late period from 5.5 years to 9 years follow-up. The Zar test was used to determine the significance of the difference between these two linear regressions.

We present the completed analysis of 165 hips. When the early and late data points were combined into one data set, the second-order regression indicated an inflection point at 6.3 years with a slightly positive inflection. There were 402 film comparisons in the early time period, and the slope and confidence interval of the regression line was 4.9μm/yr (95% CI of −28μm/yr to 38μm/yr). There were 188 film comparisons in the late period, and slope of the regression line for the late period was 10.8 μm/yr (95% CI of −58μm/yr to 80μm/yr). The Zar test showed no significant difference between the two slopes (Figure 1, p=0.886).

No significant increase in femoral head penetration was found for the late period after 5 years compared to the early period before 5 years follow-up in either analysis. Additionally, no significant late increase in wear was seen within individuals. While we continue to enroll patients, at this time we do not observe the increase in wear seen in the RSA study after 5 years.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 197 - 197
1 May 2011
Ostendorf M Malchau H Kärrholm J Dhert W Eisler T
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Of 960 first-revision total hip replacements (THR) because of deep infection identified in the Swedish Hip Arthroplasty Registry, 16.9% were treated with a permanent implant extraction, while a staged or direct reconstruction revision protocol were employed in 56.2% and 26.9% respectively. The majority of the interventions were performed more than one year after index THR, and the dominating pathogen was coagulase negative staphylococci (CNS). We found a significant shift in types of bacteria over the years (Chi-square test, p smaller than 0.001): an increase in the CNS group and a decrease in Gram-negative aerobes. Patients treated with a permanent resection were generally older (p< 0.001), had more often a previous ipsilateral hip fracture (p< 0.001), and had more frequently Gram-negative infections (p=0.02). No systematic differences in patient characteristics or pathogens were detected between one-stage or two-stage procedures, of which the latter had a median re-implantation time of 2 (range: 0.2–62) months. Of 798 (one- or two-stage) revisions, 60 (7.5%) were revised again due to recurrent infection, with no difference between the two methods, and implying a 10-year survival of 90%; 95% confidence interval (CI95%) 88.2–93.0. Previous surgery for soft-tissue problems (RR 3.2 (CI95% 1.3–7.2)) predicted a worse outcome for one-stage procedures. The prognosis of two-staged revisions improved with increasing re-implantation interval (RR 0.8 (CI95% 0.7–1.0)) per month, and a 6 month interval carried the lowest risk of repeat revision due to infection; RR 0.1 (CI95% 0.0–0.9). Staged revisions in female patients (RR 2.3, (CI95% 0.9–5.7)) and with Staphylococcus aureus infections (RR 2.3 (CI95% 0.9–5.5)) predicted a worse outcome. Ten-year survival with repeat revision for aseptic loosening as end-point was 89% (95%CI 85.7–92.0), but decreased to 79% when all reasons for revision were taken into account (95%CI 75.0–82.3) mainly because of revision for peri-prosthetic fractures.

The results suggest that direct and staged revision protocols can have a good prognosis on a national level, but efforts must be made to counteract periprosthetic fractures and the high incidence of permanent implant extraction in elderly patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 514 - 514
1 Oct 2010
Fehm M Burke D Geller J Huddleston J Malchau H
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Background: Abductor failure after total hip arthroplasty is a rare but debilitating problem. The diagnosis is difficult, and when recognized, there are few successful treatment options. The purpose of this study is to review our experience with a new surgical technique using fresh-frozen Achilles tendon allograft with an attached calcaneal bone graft to reconstruct a deficient abductor mechanism after total hip arthroplasty.

Methods: From 2003 to 2006, we performed seven abductor reconstructions with Achilles tendon allograft for patients with abductor deficiency after total hip arthroplasty. Four patients had a prior posterior approach and three had a prior anterolateral approach. At a mean of 29 months from index procedure, all seven patients suffered from symptoms of lateral hip pain and abductor weakness as documented by positive Trendelenburg sign, limp, and limited motor strength with side-lying abduction. Hip arthrograms were obtained in five of seven patients.

Results: The average pre-reconstruction Harris Hip Score was 34.7 and average pain score was 11.4. All five hip arthrograms showed extravasation of dye over the greater trochanter, confirming the diagnosis of a bald greater trochanter and massive abductor loss found at time of surgery. At a minimum 24 month follow-up and an average follow-up of 31 months, the post-reconstruction Harris Hip Score was 85.9 and the average pain score was 38.9.

Conclusions: Abductor reconstruction with Achilles tendon allograft using calcaneal bone block fastened to the greater trochanter has offered significant relief of pain and improvement in function at early follow-up in this series of patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 520 - 520
1 Oct 2010
Jibodh S Bragdon C Greene M Kandil A Malchau H
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Highly cross-linked polyethylene liners in total hip replacement (THR) have allowed the use of larger diameter femoral heads. Larger heads allow for increased range of motion, decreased implant impingement, and protection against dislocation. The purpose of this study is to report the clinical and radiographic outcomes of patients with large femoral heads with HXLPE at 5 years post-op.

A group of 124 patients (132 THRs) who had a primary THR with a 36mm or larger cobalt-chrome femoral head and a Durasul or Longevity liner (Zimmer; Warsaw, IN) were prospectively enrolled in this study. 93 THRs (88 patients) had minimum 5 year follow-up. All patients received a cementless acetabular shell (Trilogy or Inter-op, Zimmer Inc, Warsaw IN) and a highly cross-linked polyethylene liner with an inner diameter of 36 or 38mm. The median radiographic follow-up was 5.6 years (range 5.0–8.0), and patients were assessed clinically by Harris Hip score, UCLA activity score, EQ-5D, and SF-36 functional scores. Femoral head penetration was measured using the Martell Hip Analysis Suite.

No osteolysis was seen in the pelvis or proximal femur, and no components failed due to aseptic loosening. Four patients have questionable signs of bone changes around the acetabular shell with future CT scans scheduled to help reach a final determination. The median acetabular shell abduction and anteversion were 44° (30–66°) and 13° (3–33°) respectively. There was no evidence of cup migration, screw breakage, or eccentric wear on the liner. Regarding the femoral component, there were no episodes of loosening, migration, osteolysis, or fracture. There was no significant difference in the median penetration rate from post-op to longest follow-up between the 36mm (24 patients) and 38mm (4 patients) femoral head groups (0.056±0.10mm/yr and 0.060±0.05mm/yr respectively). Therefore, the data were pooled into one group. Using every post-op to follow-up comparison, the linear regression penetration rate of this combined group was 0.003 mm/yr which is within the error detection of the Martell method. The median femoral head penetration rate during the first post-op year measured 0.59±1.04 mm/yr. In contrast, the median steady state wear rate from the 1yr film to the longest follow-up measured -0.009±0.15mm/yr. A linear regression steady state wear rate from the 1 year film to every follow-up of −0.031 mm/yr indicated no correlation between the magnitude of polyethylene wear and time.

The mid-term results on this series of patients with THRs with a 36 or 38mm femoral head articulating with highly cross-linked polyethylene showed excellent clinical, radiographic, and wear results. The lack of early signs of osteolysis with the use of these large diameter femoral heads is encouraging. Continued and longer-term follow-up is needed to provide survivorship data.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 511 - 511
1 Oct 2010
Bragdon C Burke D Ekeledo A Freiberg A Greene M Harris W Malchau H
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Highly cross-linked polyethylene (HXLPE) is one of the most widely utilized bearing surfaces for total hip arthroplasty (THA). The first patients to receive XLPE will be 10 years post-op as of December 31, 2008. The purpose of this study is to report the long-term clinical and radiographic outcomes of patients implanted with HXLPE.

A group of 247 primary total hip replacements (224 patients) using HXLPE liners (Longevity or Durasul, Zimmer Inc.) with 22, 26, 28, or 32mm femoral heads were implanted between 1999 and 2001. Clinical evaluation measures included the Harris hip, EQ-5D, SF-36 functional scores, and UCLA activity scores. In addition to plain radiograph assessment, the computerized Martell method was used to measure head penetration over time. A matched group of 241 primary total hip replacements (201 patients) with the same head sizes using conventional polyethylene (PE) with a minimum of 7 years follow-up was used as a Martell method control group. The steady state penetration rate was defined as the slope of the linear regression line of the plot of head penetration from the 1 year film to each subsequent film to discount the early bedding-in process. A student’s t-test was used to compare wear rates between head sizes in each group, and a repeated-measures mixed model ANOVA was used to compare the groups for the 28mm head size.

There were no osteolytic lesions around the cup or stem, and no revisions were performed for polyethylene wear or liner fracture. Clinical outcome scores were averaged: Harris Hip 88.1±11.97, EQ-5D 74.0±27.0, SF-36 physical activity scores 53.3±8.4, SF-36 mental score 46.9±11.1, and UCLA activity 6.4±2.1. The steady state wear of the conventional polyethylene patients increased with time for both 26 and 28mm head sizes (0.144 and 0.127mm/year, respectively). No significant difference was found between the head sizes coupled with conventional polyethylene (p=0.14). Femoral head penetration in the highly cross-linked polyethylene did not increase over time after the first year. The steady state wear rates of HXLPE liners with 28mm or 32mm femoral heads were not significantly different than a slope of zero (p=0.54 for both head sizes).

Clinical follow-up results are typical of a primary THR patient population, and the radiographic results are excellent with no signs of peri-prosthetic osteolysis. Patients with PE show wear rates that are significantly different than zero indicating significant wear of the material. Conversely, patients with HXLPE display no measureable wear at 7–9 years as the wear rates were within the error detection of the Martell method. This long-term clinical and radiographic follow-up study for this new bearing material shows excellent clinical outcomes with very low in vivo wear.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 310 - 310
1 May 2010
Rolfson O Dahlberg L Nilsson J Malchau H Garellick G
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Objective: The Charnley grading system (A, B, C) has previously been shown to be a valid predictor concerning outcome after joint replacement surgery. In this study we hypothesized that anxiety/depression, one of five dimensions in the health related quality of life measurement tool EQ-5D, could predict the outcome after total hip replacement surgery.

Methods: Data from the Swedish Hip Arthroplasty Register including 6 158 patients with primary osteoarthritis were analysed. To examine the association of anxiety with respect to the outcome of pain (VAS) and satisfaction (VAS) a general linear regression model was used.

A subgroup of 481 patients in the Western Region of Sweden with complete data on individual CPP (cost per patient) was selected for the health economic analysis.

Results: The preoperative EQ-5D anxiety/depression dimension was a strong predictor for pain relief, patient satisfaction, and cost-effectiveness with surgery. Patients with comorbidity (Charnley category C) had a significant worse outcome with regards to pain relief, satisfaction and EQ-5D index scores than patients in Charnley category A and B (p< 0.001). Females generally had worse outcome scores than males in all three outcome measurements (p< 0.001).

Conclusion: Orthopaedic surgeons involved with the care of patients eligible for THR surgery should be alert to the fact that mental health may influence pain-experience and HRQoL outcome. Appropriate assessment of mental health may enable us to modify the approach in which we manage these patients, in order to optimize the outcome following joint replacement surgery.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 295 - 295
1 May 2010
Bragdon C Greene M Goldvasser D Freiberg A Malchau H
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Introduction: Electron beam irradiated highly cros-slinked polyethylene has been used in total hip arthroplasty for over 8 years. Due to its low wear characteristics, the use of femoral heads that are greater than 32mm in diameter is now available, allowing for an increase in range of motion and increased stability against dislocation when necessary. The purpose of this study is to provide a summary report on the radiographic analysis of the longest term data available on primary THR patients receiving highly cross-linked polyethylene and to compare the results of two methods of measuring femoral head penetration.

Methods: Three prospective clinical studies involving electron beam irradiated highly cross-linked polyethylene have been initiated at our center. To date, the results of: 200 hips with a minimum of 6 year follow-up with conventional sized femoral heads (primarily 28 and 32mm); 45 hips with minimum 5 year follow-up with larger sized femoral heads (primarily 36 and 38mm); and 30 hips with 5 year follow-up enrolled in a Radiostereometric analysis (RSA) study (15 patients with 28mm and 15 patients with 36mm diameter femoral heads); were available for this summary report. Data from patient administered questionnaires (Harris Hip score, UCLA activity score, and WOMAC), radiographic review, and wear analysis using RSA or the Martell Hip Analysis Suite™. In addition, for comparative purposes, wear was measured in a subset of patients using the Devane Polyware™ program.

Results: All hips had good clinical outcome at longest follow-up regardless of which femoral head size was used. There were no revisions due to polyethylene wear and no evidence of peri-prosthetic osteolysis. In general, after the bedding in period, there was no significant increase in femoral head penetration regardless of head size.

For RSA, the wear rate for the 28mm femoral head group was 0.05±0.02 while the 36mm femoral head group was 0.03±0.02, p=0.13.

For the Martell analysis, the average steady-state wear rate was −0.002 ± 0.01 mm per year and −0.026 ± 0.13 mm per year for 28mm and 32mm head sizes, respectively, p=0.62. There was no correlation between wear and time in situ or femoral head size for any of the clinical studies.

In comparing the Martell and Devane programs, the total average wear rates were significantly different, 0.07±0.05 and 0.03±0.06mm/year respectively, p=0.01. However, when the absolute values of the Martell results were used, there was no difference, p=0.22.

Conclusion: The mid-term follow-up of a large group of primary THR patients receiving highly cross-linked polyethylene components have shown no problems related to the new bearing material. Extremely low wear and lack of peri-prosthetic osteolysis are encouraging results requiring further long-term study.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 323 - 324
1 May 2010
Malchau H Slover J Bozic K Tosteson A Rubash H
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Background: The rates of primary and revision knee arthroplasty in the United States have been increasing. Simultaneously, several studies have reported increased complication rates when these procedures are performed at low-volume centers. One innovation designed to improve knee arthroplasty outcomes is computer navigation, which aims to reduce revision rates by improving the alignment achieved at surgery. The purpose of this study was to examine the impact of hospital volume on the costeffectiveness of this new technology in order to determine its feasibility and the level of evidence that should be sought prior to its adoption.

Methods: A Markov decision model was used to evaluate the cost-effectiveness of computer-assisted knee arthroplasty, in relation to hospital volume. Transition probabilities were estimated from the arthroplasty literature, and costs were based on the average reimbursement for primary and revision knee arthroplasty at out institution. Outcomes were measured in quality adjusted life years.

Results: The results demonstrate that computer-assisted surgery becomes less cost-effective as the annual hospital volume decreases, as the cost of navigation increases, and as the impact on revision rates decreases. If a center performs 250 cases per year, computer navigation will be cost-effective if the annual revision rate is reduced by 2% per year over a twenty-year period. If a center performs 150 cases per year, computer navigation is cost-effective if it results in a 2.5% reduction in the annual revision rate over a twenty-year period. If a center performs only 25 cases per year, the annual reduction in revision rates must be 13% for computer navigation to be cost-effective.

Conclusion: This analysis demonstrates that computer navigation is not likely to be a cost-effective investment in health care improvement in low volume joint replacement centers, where its benefit is most likely to be realized. However, it may be a cost-effective technology for higher volume joint replacement centers, where the decrease in the rate of knee revision needed to make the investment cost-effective is modest, if improvements in revisions rates with the use of this technology can be realized. This illustrates that hospital volume can have a substantial impact on the cost-effectiveness of new technology in surgery, and this should be carefully considered by any center considering such a large capital investment.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 447 - 447
1 Sep 2009
Thien T Malchau H Herberts P Kärrholm J
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In a previous report from a randomised study we reported excellent fixation and less proximal periprosthetic bone mineral loss around the Epoch design at 2 years follow-up when compared with a solid stem of similar design. We now present the 7 years follow-up.

Forty consecutive patients (20 men, 10 women, mean age 57, 41–74) with non-inflammatory osteoarthritis were randomised to receive either a cementless porous-coated composite stem with reduced stiffness (Epoch) or a cementless stiff stem with a porous coating (Anatomic). Patients were followed for 7 years with repeated evaluations using radiostereometry, DXA, conventional radiography and Harris Hip Score (HHS).

At 7 years 1 stem had been revised (Anatomic) due to late infection. Subsidence and stem rotations were close to zero without any difference between the two groups (p> 0,12). Median wear rates were lower than expected (0.4mm up to 7 years) for both stem designs. At 2 years loss bone mineral density was less in Gruen regions 1, 2, 6 and 7 for the Epoch stems (p< 0.04), but this difference tended to disappear with time. At 7 years only the calcar region (Gruen region 7) had significantly denser bone in the Epoch group (p< 0.001). The HHS scores did not differ (median 98, 51–100). No stem was radiographically loose.

The Epoch stem achieved excellent fixation. Wear rates were low despite use of conventionally gamma-sterilised polyethylene. This low modulus stem had positive effects on early proximal bone remodeling, but this effect decreased with time.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 35 - 35
1 Mar 2009
Kurtz S Lau E Havelin L Dybvik E Ong K Malchau H
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Starting in the 1970s, long-term survivorship of total hip and knee arthroplasty has been under investigation for the Scandinavian population with the aid of implants registries. In the United States, no national arthroplasty registry currently exists. Nationwide inpatient discharge databases in the United States have proven useful when comparing the revision burden in the United States and Scandinavia. For this study, we compared the implant survivorship in the Medicare population with contemporaneous registry-based data from well-established and validated Scandinavian arthroplasty registries. The 5% systematic sample of Medicare claims from 1997 to 2004 were examined for primary and revision THA and TKA claims. The Medicare beneficiary ID was used to follow patients longitudinally between primary and revision surgery. De-identified data from the Norwegian and Swedish national hip and knee registry were also obtained for the same time period. During the 8-year study period, 30,583 and 62,878 elective primary total hip or knee replacements, respectively, were extracted from the Medicare data. In the same time period, 41,823 and 15,927 primary total hips or knees replacements were identified from the Norwegian registry. 82,037 primary total hips were identified from the Swedish registry. Survivorship was assessed by the Kaplan-Meier method, and Cox regression was used to evaluate the effect of patient attributes and cross-country comparisons. The K-M estimate showed that 8 years post-primary surgery, 93.6% of THA and 96.2% of TKA remained revision-free among the elderly Medicare population. By comparison, among Norwegians aged 65 and above, 96.0% of THA and 93.6% of TKA remained revision-free. In the US, men had a significantly higher risk of knee revision than women, but no significant gender difference among hip revision. In Norway, men had a significantly higher risk of hip revision, but no differences in knee revisions. In Sweden, men had a significantly higher risk of hip revision (5.4% vs. 3.3%). Older patients had a reduced risk of revision as compared with younger patients, in both the US and in Norway. The survival of THA is significantly better in Norway than in the US with a hazard ratio of 1.64 (p< 0.05). On the other hand, TKA had a better survival experience in the US than in Norway, with a hazard ratio of 0.55 (p< 0.05). This is the first study to evaluate the utility of Medicare as a source of THA and TKA survivorship data and to compare prosthesis outcomes in Medicare with those from Scandinavian arthroplasty registries. Unlike the Norwegian and Swedish registry data, the reasons for revision (e.g., femoral loosening) are not captured and thus greatly limited the value of the Medicare data as a tool to understand the need for revision, thereby helping to improve implant longevity and to reduce the associated cost and burden to the patient and care provider.