Clinical and radiographic results and wear performance in different generations of a cementless porous-coated acetabular cup

We compared clinical results and wear performance in two different generations of a cementless porous-coated cup, analysing the long-term results of 83 uncemented Harris-Galante I cups (32-mm femoral head) and 93 uncemented Harris-Galante II cups (28-mm femoral head). All polyethylene liners were gamma irradiated in air. Polyethylene linear wear was estimated using a software package. The minimum follow-up was 10 years. Nine Harris-Galante I cups and two Harris-Galante II cups were revised due to aseptic loosening or polyethylene problems. The mean femoral head penetration at 6 weeks after surgery was 0.15 ± 0.05 mm for the Harris-Galante I cups and 0.12 ± 0.03 for the Harris-Galante II cups (p < 0.001);but mean wear was 0.13 ± 0.23 mm per year for the Harris-Galante I cups and 0.11 ± 0.10 for the Harris-Galante II cups (p = 0.740). Most of the metallic shells in both groups showed stable fixation. The so-called second-generation cups had lower initial polyethylene wear that resulted in less polyethylene wear at the latest the follow-up, but the overall wear rate was similar in both groups despite the different femoral head sizes and the improved locking mechanism.

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Résumé Nous avons analysé les résultats cliniques et l’usure portant sur deux types de cupules sans ciment différentes. 83 patients ont bénéficié d’une cupule sans ciment type Harris-Galante I (diamètre de la tête 32 mm) et, 93 patients d’une cupule sans ciment type Harris-Galante II (diamètre de la tête 28 mm). Tous les inserts en polyéthylène ont été irradiés aux rayons gamma en atmosphère d’air. L’usure du polyéthylène a été analysée par un logiciel informatique. Le suivi moyen a été de 10 ans. 9 cupules de type Harris-Galante I et 2 cupules de type Harris-Galante II ont été révisées pour un descellement aseptique ou pour des problèmes au niveau du polyéthylène. La pénétration moyenne de la tête fémorale, six semaines après l’intervention a été de 0,15±0,05 mm pour la Harris-Galante I et de 0,12±0,03 mm pour la Harris-Galante II (p < 0,001). L’usure moyenne a été de 0,13 ± 0,23 mm par an pour la cupule Harris-Galante I et de 0,11 ± 0,10 pour la cupule Harris-Galante II (p = 0,740). La plupart des inserts mécaniques n’ont pas présenté de défauts de stabilité. Ces cupules de deuxième génération ont une usure initiale du polyéthylène inférieure à celle de première génération par contre, l’usure moyenne est identique dans les deux groupes au plus long suivi quel que soit le diamètre de la tête fémorale et l’amélioration du mécanisme de fixation de l’insert PE.

     

A long-term follow-up study of the cementless THA with anatomic stem/HGPII cup with 22-mm head

The anatomic femoral component and Harris-Galante porous II (HGPII) cup were developed to provide more reliable bone ingrowth. We performed 20 cementless total hip arthroplasties (THAs) with anatomic stem/HGPII cup with 22-mm head in 14 consecutive patients, and evaluated the clinical and radiological results for a mean follow-up of 12.8 years. The all-anatomically designed stem provided excellent clinical and radiographic results. Four acetabular components underwent revision: three for fracture of the locking mechanism and wear of the polyethylene liner and one for the locking mechanism failure with dislocation of the HGPII cup. The abduction angles of the four revised acetabular components were apparently higher. The survivorship 13 years after surgery was 78%. Our findings show good long-term results using the anatomic femoral component, while the HGPII cup combined with 22-mm head seems to have poor durability due to locking mechanism failure.     

Locking mechanism failure in the Harris-Galante porous acetabular component associated with recurrent hip dislocation

In this review of longitudinal studies of the Harris-Galante porous acetabular component, 20% of all revisions were caused by failure of the polyethylene liner locking mechanism. We report 2 cases of locking mechanism failure in the Harris-Galante porous acetabular component presenting with recurrent dislocation. Broken tines from the acetabular locking mechanism were found embedded into the polyethylene liners in both cases. In a 79-year-old woman with recurrent dislocation, the polyethylene liner and femoral head were replaced, and the acetabular component was revised. In a 74-year-old man with chronic recurrent dislocation, the polyethylene liner and femoral head were replaced, but the acetabular component was preserved. Appropriate treatment for locking mechanism failure with a well-fixed acetabular component depends on many factors, and further long-term data are needed.     

Polyethylene liner failure in second-generation Harris-Galante acetabular components

Polyethylene liner failure of cementless acetabular components has been reported to be the most common complication of current modular cups. We performed a retrospective review of 128 consecutive primary total hip arthroplasties in 111 patients who had a second-generation Harris-Galante cup (Harris-Galante II, Zimmer, Warsaw, Ind). The mean length of the follow-up period was 8.0 years (range 5-12.9 years), with 26 cups (20.2%) having undergone revision by that time. Twenty-two hips (17.3%) had failure of the polyethylene liner. We found that polyethylene liner failure remains the main cause of revision of this modular cup. The main difference between our population of patients and other populations that have used this cup and liner is our population's cultural inclination toward squatting and leg crossing, body positions that increased the risk of impingement and eccentric wear.     

The Harris-Galante cementless THA: a 19- to 25-year follow-up study

The goal of this study was to evaluate the long-term survivorship of primary cementless total hip arthroplasty (THA) using Harris-Galante porous I acetabular and Harris-Galante porous femoral components. From July 1985 to December 1991, we performed primary cementless THA on 76 hips (70 patients). Twenty-nine patients (31 hips) died due to causes unrelated to the THA, and 6 patients (7 hips) were lost to follow-up. Of 76 hips (70 patients) studied, 38 hips (35 patients) were available for follow-up at a mean 22.5 years (range, 19-25 years) postoperatively. Mean patient age at index procedure was 51.2 years (range, 42-65 years). Average Harris Hip Score was 40.5 points preoperatively and 85.8 points at final follow-up. No patient had an early or late postoperative deep infection. Radiographically, the acetabular component fixation was stable in all 38 hips. The femoral component was bone-ingrown in 26 hips, stable-fibrous in 10, and unstable in 2. One unstable hip required revision of the femoral component. Dissociation of the polyethylene liner occurred in 3 hips without fractures of the metal locking tines and required revision of the polyethylene liner and the articular head. A total of 4 hips had documented revision, and 1 femoral component failed radiographically. The survival rate with the endpoint defined as revision surgery and radiographic loosening was 86.8% at 22.5 years of follow-up. Mean polyethylene wear was 0.085 mm/year (range, 0.031-0.15 mm). This study found that the Harris-Galante porous I acetabular and Harris-Galante porous femoral components produce excellent long-term results.     

The Harris-Galante Porous acetabular component at intermediate follow-up

Outcome of the acetabular component in 90 consecutive primary noncemented total hip arthroplasties (THAs) was prospectively studied. The acetabular cup consisted of a hemispherical titanium alloy shell with a titanium fiber-mesh porous coating and a modular polyethylene liner (Harris-Galante Porous-1, Zimmer, Warsaw, Ind). The cup was implanted using line-to-line reaming with adjunctive dome screw fixation. The femoral component consisted of a titanium alloy stem with titanium fiber-mesh porous coating and a 28-mm cobalt-chrome modular head. Mean patient age was 53 years (range: 27-75 years); male:female ratio was 48:42; and mean follow-up was 6 years (range: 4.5-8 years). One acetabular component was revised for aseptic loosening. Of 81 unrevised hips available for follow-up, mean Harris hip score was 57 preoperatively and 96 at final follow-up (72% excellent, 15% good, 1 3% fair, and none poor). Of 61 unrevised hips with adequate radiographic follow-up, radiographic failure (complete periprosthetic radiolucency) was evident in 3 (4.9%) and periacetabular osteolysis in none. Radiographic failure did not correlate with poor clinical outcome. Linear polyethylene wear rate (mean: 0.13 mm/year) did not correlate with age, gender, weight, outcome, or cup abduction angle, but did correlate with the presence of femoral periprosthetic osteolysis (0.18 mm/year with femoral osteolysis versus 0.11 mm/year without; P= .01). This series of porous-coated hemispherical cups demonstrated excellent intermediate-term clinical and radiographic outcome, comparable with similarly favorable results reported by the prosthesis designers. A potentially adverse effect of polyethylene wear on the longevity of a THA was supported by a positive correlation between polyethylene wear rate and femoral osteolysis.     

Wear and periprosthetic osteolysis of modular, hemispheric acetabular cups]

Osteolysis associated with polyethylene wear has become one of the most prevalent complications associated with uncemented modular, hemispherical cups. Sixty-five consecutive total hip arthroplasties (ABG i, Howmedica, Stryker) were followed 6-12 years. Cumulative survivorship for the cup was 55.7% after 10 years. There were 20 cups revisions because of polyethylene wear and periprosthetic osteolysis (14 cups) or cup loosening (6 cups). Stability was assessed intraoperatively, 14 cups were revised, whereas 6 new polyethylene cups were cemented into stable metal-back of acetabular component. The average annual wear of revised cups was 0.32 mm. The annual wear of not revised cups was 0.12 mm. The differences were statistically significant (p = 0.002). The mean area of osteolysis was 472 mm2 (SD 257 mm2). There was no significant correlation between wear and area of osteolysis. There was significant correlation R = 0.54, p = 0.014) between time to revision and area of osteolysis. There were no significant differences of wear of polyethylene inlay or area of osteolysis between stable and unstable acetabular cups.     

Fifteen-Year to Twenty-Year Results of Cementless Harris-Galante Porous Femoral and Harris-Galante Porous I and II Acetabular Components

This study examined long-term survivorship of primary total hip arthroplasty (THA) using cementless Harris-Galante porous femoral and Harris-Galante porous I or II acetabular components. Of 113 hips (101 patients) studied, 60 hips (53 patients) were available for follow-up at a mean of 17.2 years after surgery. A total of 10 hips had documented revision, and 2 hips had failed radiographically. The average Harris hip score was 82. Radiographically, 12 hips demonstrated eccentric wear, 8 had osteolysis, and 1 had a broken tine. The overall survival rate was 87.7%; the mean volumetric wear rate was 74.96 mm³; and the mean polyethylene linear penetration rate was 0.153 mm/y, similar to that of well-cemented THA in other series. This long-term outcome for an early-generation cementless THA is promising and provides a standard by which to judge the newer generation of cementless implants.     

Porous-coated cups fixed with screws: A 12-year clinical and radiostereometric follow-up study of 50 hips

Background?Excellent mid-term results have stimulated the use of hemispherical porous-coated cups in hip replacement. With longer follow-up, there have been problems related to polyethylene wear and liner fixation, and osteolysis has been documented in reports of selected cases. We evaluated the clinical and radiographic results of 50 patients followed for 12 years.

Patients and methods?58 consecutive patients (58 hips), mean age 55 years, were operated with Harris-Galante (HG) I or II cups using line-to-line fit and additional screw fixation. Polyethylene linersγ-sterilized in air and 32-mm ceramic heads were used. 8 patients died within 12 years, leaving 50 patients with a complete 12year follow-up. 23 of the cups were also evaluated with radiostereometry (RSA) for migration, liner stability, and wear.

Results?All metal shells were still in situ after 12 years. 4 hips had been revised due to femoral loosening. In these revisions, the liner had been exchanged due to wear and/or instability, resulting in a cup survival rate of 89%. 28 cups displayed osteolytic lesions, mainly in relation to screws. RSA revealed minimum translations, but in many cases there were pronounced liner rotations suggesting unstable liners within the metal shell. The annual proximal wear was 0.09 mm and the three-dimensional wear was 0.16 mm.

Interpretation?RSA can predict the long-term performance of cup fixation. Low migration during the initial years after implantation indicates excellent long-term results regarding fixation of the metal shell. The main problem with this design appears to be liner instability and osteolysis, factors that are probably interrelated. Because these phenomena are clinically silent, we recommend regular follow-up of patients with HG cups to avoid sudden loosening and complicated revisions.     

Cementless acetabular replacement in patients with rheumatoid arthritis: a 6- to 14-year prospective study

Sixty-three consecutive patients who had 82 Harris-Galante porous acetabular cups (HGP1) (Zimmer Inc, Warsaw, IN) implanted for the treatment of rheumatoid arthritis were prospectively assessed since 1986. At last examination, 12 patients (16 hips) had died, and 1 patient (1 hip) was lost to follow-up. A total of 65 hips in 50 patients were available for the latest review. The follow-up period was 6.8 years to 14 years (mean, 9.1 years). There had been 6 revisions: 1 for deep infection and 5 for polyethylene cup wear. Survivorship analysis for all failures estimated that 75% of hips would still be revision-free after 4558 days (12.5 years). Polyethylene wear has been identified in a further 7 cases at last examination. The average linear cup wear per year was 0.05 mm(range, 0.00-0.66 mm). There were no cases of acetabular loosening or acetabular migration. These results demonstrate the excellent durability of fixation of the HGP1 cups in patients with rheumatoid arthritis. However, a 32-mm head should probably not be used with this cup given the high associated incidence of polyethylene wear.     

Polyethylene Subluxation: A Radiographic Sign of Locking Mechanism Failure After Modular Total Knee Arthroplasty

Tibial insert locking mechanisms are intended to limit interface motion and “backside” wear in modular total knee arthroplasty (TKA). Nevertheless, anterior polyethylene subluxation is occasionally apparent on lateral radiographs after TKA, suggesting locking mechanism failure. We retrospectively identified 10 modular posterior-stabilized implants of a single design that were found to have failure of the locking mechanism at the time of revision surgery for osteolysis. Operative reports were reviewed for the presence of backside wear, and preoperative radiographs were inspected for polyethylene subluxation. All 10 implants demonstrated significant backside wear. Nine had anterior polyethylene subluxation evident on preoperative radiographs. Anterior polyethylene subluxation on the lateral radiograph is a subtle sign of failure of the locking mechanism in this modular posterior-stabilized TKA.     

The Harris-Galante total hip arthroplasty: a minimum 8-year follow-up study

A total of 93 Harris-Galante Porous I (HGP- I) prostheses were analyzed with a mean follow-up of 10.2 years. Thigh pain (28 hips) correlated with unstable fixation (P<.005), female gender (P<.045), young age (P<.05), poor distal femoral fill (P<.002), subsidence (P<.0001), and osteolysis (P<.05). Thirteen stems and 6 metallic shell cups were revised. Kaplan-Meier analysis showed 13-year survival rates of 92.5% +/- 5.8% for the metallic shell cup, 79.7% +/- 13% for the HGP-I cup, and 76.3% +/- 14.0% for the stem. Five polyethylene liners were changed because of wear >1 mm. Radiographic loosening occurred in 8 cups. Radiographic bone ingrowth was present in 54 stems, stable fibrous fixation was present in 24 stems, and unstable fixation was present in 15 stems. The mean polyethylene wear was 0.17 mm/y. Eleven hips (11.8%) had acetabular osteolysis, and 24 (25.8%) had femoral osteolysis, the latter being more frequent in unstable stems (P<.007). The HGP-I metallic cup shows better clinical and radiographic results than the stem, which frequently is associated with pain, unstable fixation, and osteolysis. Excessive polyethylene wear is frequent.     

Analysis and results of dissociation of the polyethylene liner in the Harris-Galante I acetabular component

The Harris-Galante I modular acetabular components (Zimmer, Warsaw, Ind) were most widely used in the 1980s in primary and revision total hip arthroplasty. We assessed 76 primary total hip arthroplasties performed using Harris-Galante I modular acetabular components. Dissociation of the polyethylene liner occurred in 5 patients and required revision surgery. None of the 76 hips had fractures of the metal locking tines on the metal shell. Liner dissociation was attributed to fatigue fracture of the polyethylene, a result of a gap between the liner and the metal shell. The thin polyethylene liner rim aggravated failure. The revision technique was to cement the polyethylene liner into the well-fixed Harris-Galante metal shell. The average follow-up observation period after revision surgery was 6.4 years; and there was no recurrence of dissociation, which supports the use of our revision technique.     

Porous-coated cups fixed with screws: a 12-year clinical and radiostereometric follow-up study of 50 hips

Background Excellent mid-term results have stimulated the use of hemispherical porous-coated cups in hip replacement. With longer follow-up, there have been problems related to polyethylene wear and liner fixation, and osteolysis has been documented in reports of selected cases. We evaluated the clinical and radiographic results of 50 patients followed for 12 years.

Patients and methods 58 consecutive patients (58 hips), mean age 55 years, were operated with Harris-Galante (HG) I or II cups using line-to-line fit and additional screw fixation. Polyethylene linersγ-sterilized in air and 32-mm ceramic heads were used. 8 patients died within 12 years, leaving 50 patients with a complete 12year follow-up. 23 of the cups were also evaluated with radiostereometry (RSA) for migration, liner stability, and wear.

Results All metal shells were still in situ after 12 years. 4 hips had been revised due to femoral loosening. In these revisions, the liner had been exchanged due to wear and/or instability, resulting in a cup survival rate of 89%. 28 cups displayed osteolytic lesions, mainly in relation to screws. RSA revealed minimum translations, but in many cases there were pronounced liner rotations suggesting unstable liners within the metal shell. The annual proximal wear was 0.09 mm and the three-dimensional wear was 0.16 mm.

Interpretation RSA can predict the long-term performance of cup fixation. Low migration during the initial years after implantation indicates excellent long-term results regarding fixation of the metal shell. The main problem with this design appears to be liner instability and osteolysis, factors that are probably interrelated. Because these phenomena are clinically silent, we recommend regular follow-up of patients with HG cups to avoid sudden loosening and complicated revisions.     

Cementless hemispheric acetabular components: 2–4-year results

A retrospective clinical and radiographic analysis was performed on 99 patients (106 hips) undergoing total hip arthroplasty with noncemented Harris-Galante (Zimmer, Warsaw, IN) or Optifix (Smith Nephew Richards, Memphis, TN) acetabular components. There were 94 primary and 12 revision procedures with a minimum follow-up period of 24 months (range, 24–52 months). The cups were evaluated for evidence of vertical and horizontal migration, as well as the presence of radiolucencies at the bone-implant interface. Age, sex, component inclination and medialization, cup coverage, and number of fixation screws used were examined to determine the influence of these factors on the incidence of cup migration or radiolucent line formation. A radiolucent line was present in at least one zone in 60% of the Harris-Galante and 45% of the Optifix cups. Progressive radiolucent lines were noted in two of the Optifix and three of the Harris-Galante components. Two Harris-Galante cups (1.9%) were revised. There were no Optifix cup migrations or evidence of instability in the Optifix or remaining Harris-Galante cups. Although there was a trend toward an increased incidence of radiolucencies in those cups lacking complete coverage, no statistically significant radiographic predictors for failure or impending failure could be determined from this short-term follow-up study. With the exception of the two revisions, all acetabular components performed well clinically over the study period.     

Fixation of ultrahigh-molecular-weight polyethylene liners to metal-backed acetabular cups

Locking mechanisms and metal-liner interface surfaces of six modular acetabular systems were evaluated to determine their effect on micromotion and backside wear of the polyethylene liner. Rotational and axial motion between the metal shell and polyethylene liner was measured in the Duraloc (DePuy, Warsaw, IN), Harris-Galante (Zimmer, Warsaw, IN), Impact (Biomet, Warsaw, IN), Lip Loc (Biomet). Precision Osteoloc (Howmedica, Rutherford, NJ), and Reflection (Smith & Nephew Orthopaedics, Memphis, TN) designs at the start of each test, and at 1 million, 5 million, and 10 million cycles. At 10 million cycles, the Lip Loc and Reflection cups had significantly lower rim micromotion than the Duraloc and Harris-Galante cups (F < .0010). The Impact, Precision Osteoloc, and Reflection cups had significantly lower rim subsidence than the Harris-Galante cup (F < .0025). The Harris-Galante cup had significantly greater rotational micromotion than the Lip Loc cup (F < .0074), and had significantly greater interface slippage than the Impact and Reflection cups (F < .0070). The Lip Loc produced significantly lower dome micromotion than the Harris-Galante (F < .0300). The Lip Loc and Reflection cups had significantly less backside wear than the Duraloc and Harris-Galante cups (P < .0001), the Impact cup (P < .0243), and the Precision Osteoloc (P < .0027) cup.     

A Comparison of a Second- and a Third-Generation Modular Cup Design : Is New Improved?

The highly cross-linked polyethylene liners currently used with modular uncemented cups have substantially decreased wear and osteolysis at early follow-up. However, retroacetabular osteolysis has still been reported in some cases with DePuy Orthopaedic's (Warsaw, IN) second-generation Duraloc acetabular shell. DePuy's third-generation Pinnacle cup incorporates a different shell-liner locking mechanism. We compared the clinical outcome among a matched series of 42 Duraloc and 42 Pinnacle cups at a mean follow-up of 5.9 years. Although the Harris Hip Scores and wear rates were not statistically different between the 2 cup designs, retroacetabular osteolysis behind the central hole was absent among the Pinnacle cups but noted among 19% of the Duraloc cups.     

Polyethylene liner exchange of the Harris-Galante porous I and II acetabular components without cement: results and complications

This study reviewed the long-term efficacy of the locking mechanism of the Harris-Galante porous (HGP) I and II acetabular components and the results and complications of polyethylene liner exchange without cement. There were 400 HGP-I components with a mean follow-up of 10 years (range, 2-19 years) and 78 HGP-II components with 8 years of mean follow-up (range, 2-13 years). There has been only 1 liner dislodgement (0.2%). Thirty-five hips (34 patients) have undergone liner exchange without cement. The index acetabular component was implanted as a primary procedure in 19 hips and a revision in 16 hips. No exchanged liner has dislodged at a mean follow-up time of 5.1 years (range, 2-11 years). However, there have been 7 patients (20%) with recurrent dislocation and all required reoperation. Dislocation was significantly lower when an elevated rim liner was used.     

Experiences with the Plasmacup--early stability, wear, remodelling, and outcome

Whilst advances in cementing technique have led to improvement in the survival of cemented femoral stems in total hip arthroplasty (THA), cup failure due to aseptic loosening remains a major clinical problem. These observations have led to a move away from cemented cup designs, particularly in young patients, towards uncemented implants. The Plasmacup is a hemispherical, press-fit, cementless, titanium-shelled, acetabular component with a polyethylene liner. In this article we review our experience of its pattern of early migration, wear, bone remodelling, and mid-term survival. In 18 cups followed for 2 years in subjects with a mean age at operation of 58 years, the mean total vectorial cup migration was 0.75 mm, and cup orientation remained stable (EBRA method). The mean polyethylene linear wear rate over this period was 0.21 mm/year. In 27 cups followed for 6 months using dual-energy X-ray absorptiometry (DXA), average bone loss was -5%, and the pelvic bone-remodelling pattern was consistent with the rim-loading principle of the cup design. In a clinical review of the outcome of 128 cups in 104 patients with a mean age at operation of 51 years and follow-up of 59 months, we found that 82% of patients had a good or very good Merle D'Aubigne score, and cup survival rate was 98% (Kaplan-Meier). Four cups had small radiographic areas of focal osteolysis and three had been revised (two for recurrent dislocation and one for deep sepsis; none were revised for aseptic loosening). The mean linear wear rate in this series was 0.14 mm/year. In conclusion, the Plasmacup shows satisfactory early stability, a wear rate similar to other uncemented cups, and favourable mid-term clinical function and survival rates.     

High osteolysis and revision rate with the hydroxyapatite-coated ABG hip prostheses65 hips in 56 young patients followed for 5–9 years

Background?There are few reports on the outcome of uncemented HA-coated cups in young patients.Patients?I evaluated the 7-year (5–9) results of HA-coated hip prosthesis (ABG, Stryker) in a consecutive series of 65 primary arthroplasties on 56 patients (mean age 44 years). 2 patients were lost to follow-up and 3 died.Results?The cumulative survival rate with revision for any reason as endpoint at 9 years was 98% (95% CI, 96–100) for the stem, 69% (61–77) for the acetabular metal backing, and 59% (50–67) for the polyethylene liner. 15 of 65 cups were revised on average 6 years after the primary operation and 3 more are planned. Revisions were done in 3 hips because of loosening and migration of the cup, and in 12 hips because of wear and progressive osteolysis around stable components. Only hips with migration had clinical symptoms. Visual inspection of polyethylene liners revealed wear of the articulation in all cases, loosening of the locking mechanism in 10 cases and nonarticular surface deformity in 7 hips. All original stems are in situ although femoral osteolysis was seen in 12 cases and 1 hip was reoperated because of periprosthetic traumatic fracture. Despite the high revision rate, the clinical improvement was good: the average pre- and postoperative Harris Hip Scores at the most recent follow-up were 41 and 90, respectively.Interpretation?While the results on the femoral side were good, the survival rates of the acetabular cups were poor and we stopped using ABG I hip prostheses.