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Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 50 - 50
1 Mar 2006
Tonino A Rahmy A van der Wal B Blake G Heyligers I Grimm B
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Introduction: After total hip arthroplasty (THA) the periprosthetic bone is loaded in an unphysiological manner (stress shielding), a major cause for periprosthetic bone resorption and aseptic loosening. Design, material and surface properties of the implant influence the stress shielding effect. This study investigates whether the design changes from the successful ABG-I to the ABG-II stem can be verified in perioprosthetic bone remodelling using Dual-Energy X-ray Absorptiometry (DEXA).

Methods: 51 THA patients (22f, 29m, avg. age: 60.8 years) were randomised to either ABG-I or ABG-II. DEXA measurements were performed preoperatively and 10 days (baseline), 3 weeks, 3, 6, 12 and 24 months postoperatively using standard Gruen zone analysis. At the same time clinical Merle d’Aubigne (MdA) scores were measured. Changes in bone mineral density (BMD) were expressed as percentage changes from the baseline for each of the Gruen zones (R).

Results: The average MdA score (25 ABG-I, 26 ABG-II) increased from 10.3 preoperatively to 17.3 at 24 months postoperative. The improvement was higher for ABG-II (7.5) than ABG-I (6.5) but not significant (p=0.15). During the first three postoperative months the average BMD of all zones combined dropped steeply for both the ABG-I (−5.5%) and ABG-II (−4.5%, n.s.). Beyond 3 months, the overall BMD change (zones combined) continued to develop without significant difference between both implant designs (plateau and slight recovery) but the individual zones showed distinct differences. The average BMD loss in the proximal Gruen zones was much lower for ABG-II (R1: −7.9%, R7: −3.7%) than for ABG-I (R1: −9.3%, R7: −11.9%) while distally the situation was reversed with better bone preservation for the ABG-I (R3: −2.9%, R4: −1.5%, R5: −1.7%) than for the ABG-II (R3: −6.0%, R4: −2.8%, R5: −4.6%). In the mid-stem region a transitional area was identified with better bone preservation for ABG-II in Gruen zone 6 (+2.7% vs −1.4%) and for ABG-I in Gruen zone 2 (-4.9% vs 7.9%). However, the p-values (two-sided t-test) ranged from 0.05–0.35 at statistically non-significant levels.

Discussion: The steep initial bone loss for both stem designs and all Gruen zones combined indicates that during this early postoperative phase surgical trauma and reduced loading dominate the bone remodelling process and not the type of implant. The different development of proximal and distal BMD for ABG-I and II in the period thereafter demonstrates the long-term effect of implant design verifies the design improvements (less proximal stress shielding). A parallel study identified the dominant influence of preoperative BMD on BMD loss. This explains our high standard deviation and the lack of statistical significance. The study is now expanded with patients matched for preoperative BMD.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 51 - 51
1 Mar 2006
Tonino A Geerdink C Grimm B Heyligers I
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Introduction: The Stryker ABG-I Total Hip Arthroplasty system with a Hydroxyapatite coated stem and cup has shown very promising short and mid-term clin-cial results at 2, 5 and 8 years. However, large discrepancies in component survival of the stem and cup have recently been published and require more data and further investigation about the potential causes.

Methods: All peer reviewed publications on the survival of the ABG-I hip prosthesis (9) were analysed regarding clinical results, polyethylene (PE) wear, osteolysis and survival. Own results from the first 250 consecutive ABG-I hips with a long-term follow-up of 10–15 years were added and compared.

Results: In the literature excellent survival rates of the ABG-I stem against osteolysis and aseptic loosening were reported with values ranging between 98%–100% after 5–10 years. In our own series stem survival against aseptic loosening was 100% at 10 years. No radiographic evidence of distal linear lysis was found around any stem. This was confirmed also in a histological investigation.

For the ABG-I cup the literature review gave survival rates between 59%–97% after 8–10 years. In our own study cup survival was 97.4% at 10 years. Looking at PE-wear, the literature gave average wear rates ranging from 0.24 to 0.32mm/year, values clearly above the wear rate boundary of 0.10–0.15mm/year usually considered as critical. In our own study augmented PE-wear (> 0.15mm/year) was noted in 23.6% of all implants. The majority (77%) of these implants were from patients younger than 70 years although this group only represented 57% of the total. The revision rates at 10 years reflect a similar trend with values much higher for patients below 70 years (2.8%) than above(4.9%).

Conclusions: Stem survival in our series was high, comparable to other published series and above the golden standard (cemented Charnley). However, the ABG-I cup showed lower survival rates, elevated PE-wear and augmented osteolysis around the holes. The comparatively high cup survival of our study is partly due to the high proportion of older patients. In the younger patient group PE-wear and revision rates were elevated. PE-wear is multifactorial and depends mainly on use. Some studies speculate it might be accelerated by low PE quality, crosslinking, liner fit or thickness. We found osteolysis not mainly at the rim but mostly around the 12 holes of the metal backed cup pointing at a possible pathway for wear particle migration into the reamed acetabulum as reported for other holed designs (Harris-Galante, Universal, Duraloc). As high wear and cyst formation did not always correlate it seems as if the pumping effect between flexing cup and acetabulum varies with component size, anatomy and bone quality influencing fluid flow, particle migration and osteolytic stimulus. A non-hole cup could alleviate this potential problem.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 45 - 45
1 Mar 2006
Geerdink C Tonino A Verburg A Rondhuis J Martell J Heyligers I Grimm B
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Introduction: In total hip arthroplasty (THA) polyethylene (PE) wear debris is major cause of osteolysis and aseptic implant loosening. Wear particle volumes must be reduced to increase implant survival. Various ways of crosslinking the molecular chains of PE have been proposed to increase the wear resistance of the bearing material but prospective long-term follow-up studies are scarce.

Materials & Methods A crosslinked PE acetabular insert was developed by gamma irradiating in a nitrogen atmosphere at a dose of 3MRad and subsequent annealing at 50° C for 144 hours to promote further crosslinking (“Duration” process). The Duration PE was compared to a conventionally prepared PE insert (irradiated at 3 MRad in air, no annealing) in a series of small punch tests, a hip wear simulator study and in-vivo as part of a randomized double-blind clinical study at three medical centers the PE-insert being the only variable. A total of 127 patients with 133 inserts (67 conventional, 66 Duration) were followed up between three and five years post-operatively. Wear was measured yearly by using a computer-based image analysis system. Radiographic appearance of potentially wear related phenomena such as osteolysis or loosening was assessed by an independent reviewer.

Results: Higher load at break during the small punch test confirmed the elevated crosslinking levels of Duration PE against the conventional PE. In the joint simulator Duration PE showed significantly lower volumetric wear rates (Mean SD: 21.7 2.3 mm3/10E6 cycles) than conventional PE (39.7 1.5 mm3/10E6 cycles, p< 0.05). A corresponding and significant level of wear reduction for the Duration PE was identified in-vivo (Duration: 43.7 33.6 mm3/year, conventional: 60.4 42.7 mm3/year, p=0.04). Radiographic analysis at the last follow-up gave evidence of femoral osteolytic lesions in five hips with conventional PE inserts and only one hip with a Duration insert.

Conclusions: Acetabular inserts made of crosslinked PE using the Duration process can significantly reduce in-vivo wear rates and the occurrence of potentially wear related osteolytic effects in the long-term follow-up of THA patients. The reduced clinical wear rates corresponded well with the results from the wear simulator measurements. This suggests that a PE with further increased crosslinking which shows even lower wear rates in simulator studies will lead to even lower wear and associated osteolysis in long-term clinical application.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 96 - 97
1 Mar 2006
van der Linde M Grimm B Garling E Valstar E Tonino A Heyligers I
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Introduction: In total knee arthroplasty (TKA) it remains a topic if cementless designs offer long-term stability equivalent to cemented procedures and if the components should be coated with calciumphosphate to enhance fixation. This study compares the three-dimensional migration patters of cemented and uncoated and periapatite (PA) coated tibial trays during a 2-year clinical follow-up study using roentgen stereophotogram-metric analysis (RSA) measurements as a predictor of long-term implant loosening (Ryds definition).

Methods: A double blind randomized prospective study was performed on 101 osteoarhtritic patients receiving 115 Duracon TKA. The tibial tray was either cemented (25), uncoated and uncemented (46) or PA-coated and uncemented (44). The groups were matched for sex, age, BMI and pre-op Insall score. Patients were evaluated at 1 week, 3, 6, 12 and 24 months post-operatively using standard radiographs and Insall scores. At each evaluation RSA measurements determined the translational (medial-lateral (ML), caudal-cranial (CC), anterior-posterior(AP)) and rotational (anterior tilt, external and valgus rotation) displacements of the tibial tray.

Results: Insall scores were not statistically different between the groups. Average component displacement was low for the cemented components in all directions. For the uncemented trays migration was highest in the CC direction (subsidence) and steep during the first 6 weeks. At two years the uncoated trays showed significantly more subsidence (−0.5 0.63 mm, range: −2.1 to 0.5 mm) than the cemented components (0.1 0.17 m, range: −0.2 to 0.4 mm, p< 0.05) and the PA-coated group (−0.1 0.60 mm, range: −2.8 to 0.3 mm, p< 0.05). Average subsidence of the cemented and PA-coated implants was nearly the same but variability was higher for the coated trays (p=0.01). Displacements in all other directions were not significantly different between the groups. Using Ryds definition, a total of 10 tibial trays from the cemented group (40%), 29 trays from the uncoated group (63%) and 11 trays from the PA-coated group (26%) were identified to be at risk for long-term loosening. In seven cases (all cemented) component tilt was critical.

Conclusion: At 2 years no clinical differences were found between cemented, uncoated and PA-coated tibial trays. However, RSA measurements showed significantly different migration patterns and predictions for long-term implant stability. Steep initial subsidence before stabilisation seems an inherent characteristics of uncemented fixation. In contrast, the cement layer below cemented trays can lead to AP tilt. Uncoated uncemented components migrate significantly indicating a high risk of late loosening. PA-coating reduces tray migration and the risk of long-term failure to levels equivalent to cemented fixation.