The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 86, Issue 2

Scientific Articles | February 01, 2004

Cementless Acetabular Fixation at Fifteen Years: A Comparison with the Same Surgeon's Results Following Acetabular Fixation with Cement

John L. Gaffey, BS¹; John J. Callaghan, MD¹; Douglas R. Pedersen, PhD¹; Devon D. Goetz, MD²; Patrick M. Sullivan, MD²; Richard C. Johnston, MD¹

¹ Department of Orthopaedics, University of Iowa Health Care, 200 Hawkins Drive, Iowa City, Iowa 52242. E-mail address for J.J. Callaghan: john-callaghan@uiowa.edu
² Des Moines Orthopaedic Surgeons, 600 Westown Parkway, West Des-Moines, IA 50266

View Disclosures and Other Information

In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from the National Institutes of Health (AR47653) and DePuy. None of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. A commercial entity (DePuy) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at the University of Iowa Health Care, Iowa City, and the Iowa Methodist Medical Center, Des Moines, Iowa

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J Bone Joint Surg Am, 2004 Feb 01;86(2):257-261

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Abstract

Background: Loosening of the acetabular component is the major long-term problem associated with total hip arthroplasty with cement. The purpose of the present study was to evaluate the minimum thirteen-year results associated with cementless acetabular components that had been inserted by a single surgeon and to compare them with the results associated with cemented acetabular components that had been inserted by the same surgeon.

Methods: One hundred and twenty consecutive, nonselected primary total hip replacements were performed in 108 patients with use of a Harris-Galante-I cementless acetabular component and a cemented femoral component with a 28-mm head. The patients were evaluated clinically with use of a standard terminology questionnaire, and they were evaluated radiographically for loosening, component migration, wear, and osteolysis. The rates of revision for aseptic loosening and radiographic evidence of loosening for this cohort were compared with the rates for four previously reviewed consecutive series of hips in which the acetabular component had been inserted with cement. All patients were managed by the same surgeon, were followed for thirteen to fifteen years, and were evaluated with use of the same two criteria (revision and loosening) as the end points for Kaplan-Meier analysis.

Results: Sixty-six patients (seventy-two hips) were living and forty-two patients (forty-eight hips) had died after thirteen to fifteen years of follow-up. No acetabular component had been revised because of aseptic loosening, and no acetabular component had migrated. With revision of the acetabular component for any reason as the end point, the survival rate was 81% ± 8% at fifteen years. With revision of the acetabular component for clinical failure (osteolysis, wear, loosening, or dislocation) as the end point, the survival rate was 94% ± 8% at fifteen years. Among the seventy hips with at least thirteen years of radiographic follow-up, five had pelvic osteolysis and three had had revision of a well-fixed acetabular component because of pelvic osteolysis secondary to polyethylene wear. The mean linear wear rate was 0.15 mm/yr (0.12 mm/yr when one outlier was excluded).

Conclusions: In terms of fixation, Harris-Galante-I cementless acetabular components performed better than did cemented 22-mm-inner-diameter Charnley acetabular components as well as 28-mm-inner-diameter all-polyethylene and metal-backed acetabular components that had been inserted by the same surgeon. However, the rate of wear was greater in association with the Harris-Galante-I cementless components than it was in association with the Charnley cemented all-polyethylene components.

Level of Evidence: Therapeutic study, Level III-2 (retrospective cohort study). See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Loosening of the acetabular component is now recognized as the major long-term problem associated with total hip arthroplasty with cement^1,2. In the early 1980s, cementless porous-coated acetabular components were developed in the hope of improving the durability of acetabular fixation. The senior author (R.C.J.) began to use the Harris-Galante-I acetabular component (Zimmer, Warsaw, Indiana) in all patients in January 1986. The purpose of the present study was to evaluate, after thirteen to fifteen years of follow-up, the senior author's results with use of this device for primary total hip replacement and to compare them with the results in previous cohorts of patients who had been managed by the same surgeon with several types of cemented acetabular components.

Materials and Methods

Materials and Methods | Results | Discussion | References

Between January 1986 and July 1987, the senior author performed 120 consecutive, nonselected primary total hip replacements in 108 patients. The average age of the patients at the time of surgery was 62.6 years (range, 26.8 to 86.0 years). The male-to-female ratio was 42:66. The average weight was 78 kg (range, 37 to 145 kg), and the average height was 167 cm (range, 119 to 193 cm). The diagnosis was primary osteoarthritis for eighty-six hips, posttraumatic arthritis for thirteen, developmental dysplasia for seven, slipped capital femoral epiphysis for four, rheumatoid arthritis for three, osteonecrosis for one, Legg-Perthes disease for four, Morquio disease for one, and spastic hemiplegia with chronic dislocation for one.

The Harris-Galante-I acetabular component and the Iowa precoated femoral component (Zimmer) were used in all patients. The shell of the Harris-Galante-I acetabular component is made from titanium alloy and has a sintered titanium fiber-metal porous coating. Multiple screw-holes allow for dome screw fixation. The Iowa precoated femoral component has a grit-blasted (80-microinch Ra [2-µm Ra]) surface finish with a proximally applied coating of polymethylmethacrylate.

On-line reaming of the acetabulum (reaming to the diameter of the shell that was to be implanted) was performed in all cases. Two or three 5.1-mm titanium-alloy dome screws were used to augment fixation. The femoral cementing technique included the use of a distal femoral cement plug as well as the use of a cement gun to deliver Simplex P cement (Howmedica, Rutherford, New Jersey), which had been centrifuged for porosity reduction. A 28-mm femoral head was used in all cases.

Living patients were evaluated thirteen to fifteen years after total hip arthroplasty, both clinically (with use of a standard terminology questionnaire³) and radiographically (with use of the most recent low anteroposterior pelvic radiograph, which included the tip of the femoral component). The most recent radiograph was compared with the immediate postoperative radiograph as well as with any interim serial radiographs. Radiographs were evaluated by two of us (J.J.C. and J.L.G.) for evidence of acetabular migration according to the criteria of Massin et al.⁴ as well as for any radiolucent lines or osteolytic lesions measuring 1 cm² in the zones described by DeLee and Charnley⁵. The acetabular component was considered to be radiographically loose if it had migrated >5 mm or if the radiographs demonstrated circumferential radiolucent lines, including in the area around the screws. Femoral head penetration into the polyethylene was measured with use of the digital edge-detection technique reported by Shaver et al.⁶.

The results for this cohort with regard to revision for aseptic loosening and radiographic evidence of loosening (as indicated by a loose component at the time of revision or by the detection of component migration or circumferential radiolucent lines on radiographs) were compared with the results for four previously reviewed cohorts of consecutive series of hips that had been treated by the same surgeon⁷ in which the acetabular component had been inserted with cement, followed for thirteen to fifteen years, and evaluated with use of the same two criteria (revision and loosening) as end points for Kaplan-Meier analysis⁸. The comparative groups included 330 Charnley total hip replacements (Zimmer) that had been performed between 1970 and 1972 and followed for a minimum of twenty-five years, 141 Charnley total hip replacements that had been performed between 1976 and 1978 and followed for a minimum of fifteen years, eighty-one total hip replacements that had been performed with use of an all-polyethylene acetabular component with a 28-mm inner diameter (Zimmer) and followed for thirteen to fifteen years, and 304 total hip replacements that had been performed with use of a TiBac metal-backed acetabular component with a 28-mm inner diameter (Zimmer) and followed for a minimum of fifteen years. The average age of the patients in these cohorts was 65.0, 67.3, 70.0, and 70.0 years, respectively, compared with 62.6 years for the patients in the cohort treated with a cementless acetabular component. The log-rank test was used to compare survivorship curves.

The survival of the implant with regard to revision, loosening, or both was evaluated with use of the Kaplan-Meier method. Survivorship curves with corresponding confidence intervals were generated, with failure defined according to three different end points: (1) revision of the acetabular component for any reason, (2) revision of the acetabular component because of aseptic loosening, and (3) revision of the acetabular component shell or liner for a clinically relevant reason. A survivorship curve also was generated for radiographic evidence of acetabular loosening. The Wilcoxon rank-sum test was used to compare rates of wear according to categorical variables because these rates are not distributed normally. The Spearman correlation coefficient was used to examine the linear correlations of age and weight with wear. The log-rank test was used to compare the survivorship curves of the cohort managed with the Harris-Galante-I cementless acetabular component with those of the four cohorts managed with cemented components.

Results

Materials and Methods | Results | Discussion | References

Thirteen to fifteen years after total hip arthroplasty, sixty-six patients (seventy-two hips) were living and forty-two patients (forty-eight hips) had died. No acetabular component had been revised because of aseptic loosening. Three secure acetabular components had been revised because of pelvic osteolysis secondary to polyethylene wear. Twelve hips had had an exchange of the acetabular liner at the time of revision for aseptic loosening of the Iowa femoral component. An additional three hips had undergone liner exchange at the time of revision for dislocation. In one hip, a constrained liner had been inserted into a secure shell at the time of revision of a loose femoral component. All of these acetabular shells were stable at the time of revision and were left in place.

The average duration of radiographic follow-up for the forty-two patients (forty-eight hips) who had died was 5.4 years (range, 0.13 to 12.8 years). In this group, no hip was revised because of aseptic loosening of the acetabular component, no hip demonstrated radiographic evidence of loosening of the acetabular component, and one hip demonstrated pelvic osteolysis at the time of revision for aseptic loosening of the femoral component. This hip was treated with bone-grafting and liner exchange with retention of the acetabular shell.

A thirteen to fifteen-year follow-up radiograph was available for seventy (97.2%) of the seventy-two hips in the group of sixty-six patients who were still alive. No hip demonstrated evidence of acetabular component migration. Forty hips (57.1%) had a radiolucent line in at least one zone around the acetabular component. Seven hips (10.0%) had radiolucent lines in all three zones but not around the screws. All of these radiolucent lines were <1 mm in width. Pelvic osteolysis was observed around the acetabular component in five hips (7.1%). Zonal analysis revealed zone-I lesions in two hips (2.9%), zone-II lesions in six hips (8.6%), and zone-III lesions in three hips (4.3%).

The average linear wear rate was 0.15 mm/yr (range, 0.007 to 1.36 mm/yr). The wear rate was higher for hips that had required revision of the femoral component (0.28 mm/yr; range, 0.03 to 1.36 mm/yr), but not significantly so (p = 0.171). When the outlier (a wear rate of 1.36 mm/yr in a patient who had had recurrent dislocations and had undergone revision within the first year) was excluded, the average linear wear rate was 0.12 mm/yr.

Linear wear was not significantly related to activity level on the standard terminology questionnaire (p = 0.5575, Spearman correlation), but it was significantly related to younger age (p = 0.05, Spearman correlation) and male gender (p = 0.002, Wilcoxon rank-sum test). Two hips demonstrated a fracture in the acetabular tine-capturing mechanism.

With revision of the acetabular component for aseptic loosening as the end point, the survival rate in the current series of cementless acetabular components was not significantly different from that in the series of cemented Charnley implants that had been followed for a minimum of twenty-five years (p = 0.0778) (Fig. 1). However, the rate of revision in the current series was significantly lower than the rates in the series of Charnley implants that had been followed for a minimum of fifteen years (p = 0.0026, log-rank test), the series of TiBac metal-backed components (p = 0.0108), and the series of all-polyethylene components used in conjunction with a 28-mm head (p < 0.0001). With acetabular loosening (as indicated by a loose component at the time of revision or by component migration or circumferential radiolucent lines as seen on a radiograph) as the end point, the survival of the components in the current study group was significantly different from those in the two series of Charnley implants (p = 0.0040 for the twenty-five-year series and p < 0.0001 for the fifteen-year series) (Fig. 2). In addition, significant increases in loosening were noted in association with the TiBac metal-backed components used in conjunction with a 28-mm head (p < 0.0001) and the all-polyethylene components used in conjunction with a 28-mm head (p < 0.0001). The average rate of linear acetabular wear was 0.09 mm/yr for the twenty-five-year series and 0.1 mm/yr for the fifteen-year series of Charnley components used in conjunction with a 22-mm head, compared with 0.15 mm/yr for the cementless Harris-Galante-I components used in conjunction with a 28-mm head.

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Fig. 1: Composite survivorship curves for all cohorts, with revision for aseptic acetabular loosening as the end point.

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Fig. 2: Composite survivorship curves for all cohorts, with acetabular loosening (as indicated by a loose component at the time of revision or by the detection of migration or circumferential radiolucent lines on radiographs) as the end point.

When the end point was defined as revision of the acetabular component (that is, revision of the shell and/or liner for any reason, including incidental exchange of the liner at the time of femoral revision), the survival rate of the Harris-Galante-I cementless component was 81% ± 8% (Fig. 3). When the end point was defined as revision of the acetabular component for clinical failure (that is, revision for osteolysis, wear, loosening, or recurrent dislocation, with exclusion of incidental liner exchange at the time of femoral revision), the survival rate was 94% ± 8% at fifteen years (Fig. 4).

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Fig. 3: Survivorship curve for the Harris-Galante-I component, with revision of the shell or liner for any reason (including incidental liner exchange at the time of femoral revision) as the end point.

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Fig. 4: Survivorship curve for the Harris-Galante-I component, with revision for a clinically relevant reason (osteolysis, wear, loosening, or dislocation, with exclusion of incidental liner exchange at the time of femoral revision) as the end point.

Discussion

Materials and Methods | Results | Discussion | References

Long-term follow-up is necessary in order to evaluate the durability of cementless acetabular fixation following primary total hip arthroplasty. In the present study, we compared the durability of the cementless Harris-Galante-I acetabular component with that of cemented acetabular components after thirteen to fifteen years of follow-up.

The strength of the present study derives from the fact that it was a minimum thirteen-year follow-up of a series of consecutive, nonselected procedures performed by a single surgeon who used the same cementless acetabular and cemented femoral components. The procedures in the four comparative series of cemented acetabular components were performed by the same surgeon, but the evaluation was performed by an investigator who was not involved in the surgery.

A weakness of the study is that the femoral component that was used is now recognized as having a high failure rate; however, the acetabular wear rates in hips that had had failure of the femoral component were no different from the wear rates in hips with a secure femoral component. Because a number of acetabular liners were exchanged at the time of femoral revision, the survival rate with any acetabular reoperation as the end point was only 81% (Fig. 3). Pelvic osteolysis is difficult to detect radiographically; therefore, our reported prevalence of pelvic osteolysis represents the minimum amount that was truly present. An additional weakness of the study is that, although all of the comparison cohorts were consecutive and nonselected, the average age of the patients in the study group was sixty-three years whereas the average age of the patients in the other cohorts ranged from sixty-five to seventy years.

Our results demonstrate that the Harris-Galante-I cementless acetabular component had better durability (in terms of fixation) than did the cemented Charnley component (when assessed at fifteen years), the cemented all-polyethylene component, and the cemented metal-backed component (Figs. 1 and 2). However, when the end point for failure was defined as acetabular revision for any reason (including incidental liner exchange) or acetabular revision for a clinically relevant reason, the survival rate dropped to 81% (Fig. 3) and 94% (Fig. 4), respectively. In addition, the average linear wear rate of 0.15 mm/yr (0.12 mm/yr after excluding the one outlier) and the osteolysis rate of 7.1% in living patients are both of concern for the next decade of use, especially considering that these components were used in conjunction with 28-mm heads. These wear rates were higher than the rate of 0.09 to 0.10 mm/yr that we reported in association with the Charnley implants, which were used in conjunction with 22-mm heads^1,7. Circumferential radiolucent lines measuring <1 mm in width were observed around seven of seventy acetabular shells, but in no case had the shell migrated and in no case did the radiolucent lines extend around the screws.

The present study demonstrates that, in terms of fixation, the fifteen-year durability of the Harris-Galante-I cementless acetabular component is at least comparable with that of any cemented acetabular implant. It also demonstrates that the secure fixation and low prevalence of osteolysis that have been reported by other authors in association with this implant after shorter durations of follow-up are maintained at fifteen years^9,10. This has not been true for all cementless acetabular devices^11-13. However, as our survivorship curves demonstrate, the second decade of use is when loosening and the need for revision of cemented acetabular components markedly increase. Although we are hopeful that cementless fixation will prove to be better than cemented devices into the second decade, we are concerned that revision related to wear and osteolysis may increase dramatically. Only additional follow-up can answer this concern.

References

Materials and Methods | Results | Discussion | References

Callaghan JJ, Albright JC, Goetz DD, Olejniczak JP, Johnston RC. Charnley total hip arthroplasty with cement. Minimum twenty-five-year follow-up. J Bone Joint Surg Am.2000;82: 487-97.82487 2000

García-Cimbrelo E, Munuera L. Early and late loosening of the acetabular cup after low-friction arthroplasty. J Bone Joint Surg Am.1992;74: 1119-29.741119 1992 [PubMed]

Johnston RC, Fitzgerald RH Jr, Harris WH, Poss R, Muller ME, Sledge CB. Clinical and radiographic evaluation of total hip replacement. A standard system of terminology for reporting results. J Bone Joint Surg Am.1990; 72: 161-8. Erratum in: J Bone Joint Surg Am. 1991;73:952.72161 1990 [PubMed]

Massin P, Schmidt L, Engh CA. Evaluation of cementless acetabular component migration. An experimental study. J Arthroplasty.1989;4: 245-51.4245 1989 [PubMed][CrossRef]

DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orthop.1976;121: 20-32.12120 1976 [PubMed]

Shaver SM, Brown TD, Hillis SL, Callaghan JJ. Digital edge-detection measurement of polyethylene wear after total hip arthroplasty. J Bone Joint Surg Am.1997;79: 690-700.79690 1997 [PubMed]

Hop JD, Callaghan JJ, Olejniczak JP, Pedersen DR, Brown TD, Johnston RC. Contribution of cable debris generation to accelerated polyethylene wear. Clin Orthop.1997;344: 20-32.34420 1997

Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc.1958;53: 457-81.53457 1958 [CrossRef]

Clohisy JC, Harris WH. The Harris-Galante porous-coated acetabular component with screw fixation. An average ten-year follow-up study. J Bone Joint Surg Am.1999;81: 66-73.8166 1999

Latimer HA, Lachiewicz PF. Porous-coated acetabular components with screw fixation. Five to ten-year results. J Bone Joint Surg Am.1996;78: 975-81.78975 1996 [PubMed]

Engh CA Jr, Culpepper WJ 2nd, Engh CA. Long-term results of use of the anatomic medullary locking prosthesis in total hip arthroplasty. J Bone Joint Surg Am.1997;79: 177-84.79177 1997 [PubMed][CrossRef]

Manley MT, Capello WN, D'Antonio JA, Edidin AA, Geeskink RG. Fixation of acetabular cups without cement in total hip arthroplasty. A comparison of three different implant surfaces at a minimum duration of follow-up of five years. J Bone Joint Surg Am.1998;80: 1175-85.801175 1998

Xenos JS, Callaghan JJ, Heekin RD, Hopkinson WJ, Savory CG, Moore MS. The porous-coated anatomic total hip prosthesis, inserted without cement. A prospective study with a minimum of ten years of follow-up. J Bone Joint Surg Am.1999;81: 74-82.8174 1999 [PubMed]

Topics

dislocations ; femur ; hip region ; hip joint ; metals ; osteolysis ; survival rate ; hip replacement arthroplasty ; polyethylene ; cohort studies, retrospective

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John L. Gaffey, John J. Callaghan, Douglas R. Pedersen, Devon D. Goetz, Patrick M. Sullivan, Richard C. Johnston; Cementless Acetabular Fixation at Fifteen YearsA Comparison with the Same Surgeon's Results Following Acetabular Fixation with Cement. The Journal of Bone & Joint Surgery. 2004 Feb;86(2):257-261.

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