Proximal Head Penetration Research Articles

The Use of Large Metal Heads in Thin Vitamin E–Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial

BackgroundVitamin E–doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA. MethodsThere were 96 candidates for uncemented THA who were randomly allocated to either the largest possible metal head (36 to 44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration, measured with a model-based radiostereometric analysis. Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The midterm results of the trial at 5 years are presented. ResultsThe median total proximal head penetration (interquartile range) was −0.04 mm (−0.12 to 0.02) in the intervention group and −0.03 mm (−0.14 to 0.05) in the control group (P = .691). The rates of periacetabular radiolucencies were 1 of 44 and 4 of 42 (P = .197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median University of California Level of Activity score 7 versus 6, P = .020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1). ConclusionsLarge metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.

Vitamin E infused highly cross-linked cemented cups in total hip arthroplasty show good wear pattern and stabilize satisfactorily: a randomized, controlled RSA trial with 5-year follow-up.

Background and purposeVitamin E infused highly cross-linked polyethylene (VEPE) was introduced in order to enhance oxidative resistance in highly cross-linked polyethylene cups in total hip arthroplasty (THA). We have, with a follow-up of 5 years, evaluated wear characteristics of 2 identically designed cemented cups with the only difference being the material, VEPE or ultra-high molecular weight polyethylene (UHMWPE). Furthermore, we report cup migration and clinical outcome.Patients and methods48 patients with primary osteoarthritis were randomized to either UHMWPE or VEPE cups. Patients were followed with radiostereometric analysis (RSA) from the first postoperative day, at 3 months, 1, 2, and 5 years as well as with hip-specific outcome questionnaires.ResultsAt 3 months the mean proximal head penetration for UHMWPE was 0.07 mm (95% CI 0.03–0.11) and for VEPE 0.06 mm (–0.01 to 0.13). Thereafter, there was a continuous annual wear of 0.08 mm/year, up to 0.46 mm (0.36–0.57) at 5 years, for the UHMWPE cup. The VEPE cup showed low annual wear of 0.01 mm/year, up to 0.09 mm (0.02–0.16) at 5 years. In the first 3 months the UHMWPE cup migrated cranially 0.08 mm (0.03–0.13) whereas the VEPE cup migrated 0.17 mm (0.10–0.24), Thereafter, they showed similar migration patterns with stabilization between 2 and 5 years up to 0.21 mm (0.04–0.39) and 0.24 mm (0.13–0.36) respectively. The HOOS remained good up to 5 years, and no cup was revised.InterpretationCompared with otherwise identical UHMWPE cups the cemented VEPE cup shows statistically significant reduction of wear up to 5 years and both cup types stabilize well with good clinical outcome.

Does the use of the largest possible metal head increase the wear of vitamin E-doped cross-linked polyethylene? Two-year results from a randomized controlled trial.

We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty. In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes. At two years, 44 patients in each group were available for RSA assessment. The median total two-year proximal head penetration was -0.02 mm (IQR -0.09 to 0.07; p = 0.548) for the largest possible head and -0.01 mm (IQR -0.07 to 0.10; p = 0.525) for 32 mm heads. Their difference was not statistically significant (p = 0.323). Neither group demonstrated a bedding-in period. The median steady-state volumetric wear rates were 6.1 mm3/year (IQR -59 to 57) and 3.5 mm3/year (-21 to 34) respectively, and did not differ between the groups (p = 0.848). There were no statistically significant differences in periacetabular radiolucencies or patient-reported outcomes. The use of the largest possible metal head did not increase vitamin E-doped cross-linked polyethylene wear compared with 32 mm heads at two years. Linear wear was negligible and volumetric wear rates were very low in both head size groups. There was a tendency towards higher values of volumetric wear in large heads that warrants longer-term evaluation before any definite conclusions about the association between head size and wear can be drawn. Cite this article: Bone Joint J2021;103-B(7):1206-1214.

Highly cross-linked polyethylene still outperforms conventional polyethylene in THA: 10-year RSA results

Background and purpose — Cup wear in total hip arthroplasty (THA) can be affected by different manufacturing processes of the polyethylene (PE). We report the long-term wear pattern differences, as well as early creep behavior, between conventional PE and highly cross-linked PE (HXLPE) liners, as measured with radiostereometry (RSA) up to 10 years. We also compare migration and clinical outcome of 2 similar uncemented cups with different backside surface roughness. Patients and methods — We included 45 patients with primary osteoarthritis. 23 received a conventional liner and 22 an HXLPE liner in a similar uncemented cup, but with a slightly rougher surface. The patients were followed up with RSA and hip-specific outcome questionnaire (HOOS) at 3 months, 1, 2, 5, and 10 years. Results — During the first 3 months both liners showed expected deformation with mean proximal head penetration of 0.39 mm (conventional PE) and 0.21 mm (HXLPE). Between 3 months and 10 years there was a difference in annual wear with 0.12 mm/year for the conventional liner and 0.02 mm/year for the HXLPE liner. The cup with rougher surface had less initial migration but both types had stabilized after 3 months. The HOOS scores improved after surgery and remained high for both groups throughout the study period. Interpretation — Up to 10 years the HXLPE has consistent lower annual wear, possibly contributing to longer survival of the THA, compared with conventional PE. All patients reported good results regardless of liner type.

Five-Year Experience of Vitamin E–Diffused Highly Cross-Linked Polyethylene Wear in Total Hip Arthroplasty Assessed by Radiostereometric Analysis

BackgroundVitamin E–diffused highly cross-linked polyethylene (VEPE) was developed to reduce oxidation without compromising mechanical strength. The purpose of this study was to evaluate VEPE in vivo using radiostereometric analysis (RSA) and patient-reported outcome measures (PROMs). MethodsFifty-one hips were enrolled. Each patient received a VEPE liner, a porous titanium shell, and an uncemented stem with a 32-mm cobalt–chrome femoral head. Tantalum beads were inserted into the VEPE to measure femoral head penetration using RSA. RSA radiographs and PROMs were obtained preoperatively immediately after surgery, 6 months, 1, 2, 3, and 5 years after surgery. ResultsForty-seven hips returned at 3 years, and 42 hip at 5 years. The mean ± standard error of the mean proximal head penetration into the polyethylene was 0.06 ± 0.01 at 5 years. The amount of head penetration did not change significantly with increasing time in vivo. The mean ± standard error of the mean Harris Hip Score was 58 ± 2 preoperatively, which improved significantly to 93 ± 2 at 5 years (P < .001). ConclusionThe head penetration into VEPE liners was low compared with non-VEPE at 5 years. After settling of the liners in the early period, no significant head penetration occurred from 2- to 5-year follow-up. All PROMs improved significantly from preoperative to postoperative and remained very favorable at 5 years. This study documents the longest-term evaluation of in vivo wear performance of VEPE.

Oxinium modular femoral heads do not reduce polyethylene wear in cemented total hip arthroplasty at five years: a randomised trial of 120 hips using radiostereometric analysis.

We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo. A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr. The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score. There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001). In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE.

Wear of a sequentially annealed polyethylene acetabular liner

Background and purpose — We previously reported on a randomized controlled trial (RCT) that examined the effect of adding tobramycin to bone cement after femoral stem migration. The present study examined femoral head penetration into both conventional and highly crosslinked polyethylene acetabular liners in the same group of RCT patients, with a minimum of 5 years of postoperative follow-up.Patients and methods — Linear penetration of the femoral head into an X3 (Stryker) crosslinked polyethylene (XLPE) liner was measured in 18 patients (19 hips) using radiostereometric analysis (RSA). Femoral head penetration was also measured in 6 patients (6 hips) with a conventional polyethylene liner (CPE), which served as a control group.Results — The median proximal femoral head penetration in the XLPE group after 5.5 years was 0.025 mm with a steady-state penetration rate of 0.001 mm/year between year 1 and year 5. The CPE liner showed a median proximal head penetration of 0.274 mm after 7.2 years, at a rate of 0.037 mm/year.Interpretation — The Trident X3 sequentially annealed XLPE liner shows excellent in vivo wear resistance compared to non-crosslinked CPE liners at medium-term implantation. The rate of linear head penetration in the XLPE liners after > 5 years of follow-up was 0.001 mm/year, which is in close agreement with the results of previous studies.

No adverse effects of submelt-annealed highly crosslinked polyethylene in cemented cups

Background and purpose Highly crosslinked polyethylene (PE) is in standard use worldwide. Differences in the crosslinking procedure may affect the clinical performance. Experimenatal data from retrieved cups have shown free radicals and excessive wear of annealed highly crosslinked PE. We have previously reported low wear and good clinical performance after 6 years with this implant, and now report on the 10-year results.Patients and methods In 8 patients, we measured wear of annealed highly crosslinked PE prospectively with radiostereometry after 10 years. Activity was assessed by UCLA activity score and a specifically designed activity score. Conventional radiographs were evaluated for osteolysis and clinical outcome by the Harris hip score (HHS).Results The mean (95% CI) proximal head penetration for highly crosslinked PE after 10 years was 0.07 (–0.015 to 0.153) mm, and the 3D wear was 0.2 (0.026 to 0.36) mm. Without creep, proximal head penetration was 0.02 (–0.026 to 0.066) mm and for 3D penetration was 0.016 (–0.47 to 0.08) mm. This represents an annual proximal wear of less than 2 µm. All cups were clinically and radiographically stable but showed a tendency of increased rotation after 5 years.Interpretation Wear for annealed highly crosslinked PE is extremely low up to 10 years. Free radicals do not affect mechanical performance or lead to clinically adverse effects. Creep stops after the first 6 months after implantation. Highly crosslinked PE is a true competitor of hard-on-hard bearings.

Less wear with aluminium-oxide heads than cobalt-chrome heads with ultra high molecular weight cemented polyethylene cups: A ten-year follow-up with radiostereometry

Wear is a major contributor to osteolysis and aseptic loosening of total hip replacements (THR). Both alumina (Al(2)O(3)) and cobalt-chrome (CoCr) femoral heads are commonly used. We investigated wear comparing alumina heads to cobalt-chrome heads against conventional cemented polyethylene (PE) cups for up to ten years. Linear wear was measured with radiostereometry (RSA). Our material was derived from two prospective randomised trials that investigated fixation of femoral stems, not wear, and was evaluated retrospectively (Level III). The mean (95% CI) proximal head penetration was 0.96 mm (0.68-1.23) in the cobalt-chrome group and 0.42 mm (0.30-0.53) in the alumina group at ten years (P = 0.001). The mean (95% CI) 3D penetration was 1.07 mm (0.79-1.35) and 0.53 mm (0.38-0.63), respectively, at ten years (P = 0.001). Alumina heads performed better than cobalt-chrome heads in this study after ten-year follow-up.

Second-generation Highly Cross-linked X3™ Polyethylene Wear: A Preliminary Radiostereometric Analysis Study

First-generation highly cross-linked polyethylene liners have reduced the incidence of wear particle-induced osteolysis. However, failed acetabular liners have shown evidence of surface cracking, mechanical failure, and oxidative damage. This has led to the development of second-generation highly cross-linked polyethylene, which has improved wear and mechanical properties and resistance to oxidation in vitro. Owing to its recent introduction, there are no publications describing its clinical performance. We assessed early clinical wear of a second-generation highly cross-linked polyethylene liner and compared its clinical performance with the published results of hip simulator tests and with first-generation highly cross-linked polyethylene annealed liners. Twenty-one patients were enrolled in a prospective cohort study. Clinical outcome and femoral head penetration were measured for 19 patients at 6 months and 1 and 2 years postoperatively. The median proximal head penetration was 0.009 mm and 0.024 mm at 1 and 2 years, respectively. The median two-dimensional (2-D) head penetration was 0.083 mm and 0.060 mm at 1 and 2 years, respectively. The median proximal wear rate between 1 and 2 years was 0.015 mm/year. The wear rate calculated was similar to the in vitro wear rate reported for this material; however, it was less than the detection threshold for this technique. Although longer followup is required for wear to reach a clinically quantifiable level, this low level of wear is encouraging for the future clinical performance of this material. Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Wear of a highly cross-linked polyethylene liner: a preliminary RSA study

Wear induced peri-prosthetic osteolysis and aseptic loosening remain the major contributing factors to failure of total hip arthroplasty. To reduce wear particles from acetabular liners, the process of polyethylene cross-linking has been modified. In this study, we examine the wear of Marathon™ acetabular liners using Radiostereometric Analysis. Thirty patients were enrolled in a prospective cohort study. Femoral head penetration was calculated for 25 patients at 6 months, 1 and 2 years postoperatively. The mean proximal head penetration was 0.067 mm at 6 months, 0.113 mm at 1 year and 0.120 mm at 2 years. The mean three-dimensional femoral head penetration was 0.240 mm at 6 months, 0.230 mm at 1 year and 0.232 mm at 2 years. For both parameters, there was no measurable wear between 1 and 2 years, and the mean annual linear wear was less than 0.06 mm/year, which is less than the suggested osteolysis threshold for polyethylene. All patients demonstrated a dramatic improvement in clinical scores. These results were comparable with other studies that used alternative techniques with conventional radiography to evaluate wear for Marathon™. Long-term studies using the RSA method are recommended to further quantify the clinical performance of this polyethylene liner.

Very low wear of non-remelted highly cross-linked polyethylene cups: An RSA study lasting up to 6 years

Background and purpose Highly cross-linked polyethylenes (PEs) all appear to reduce wear dramatically in laboratory studies, although there is substantial variation in this respect between manufacturers. Nonremelted cross-linked PE is almost as tough as unirradiated PE, but is not completely stable and can oxidize in vivo, as has been shown in recent retrievals studies.We had reported low wear and good clinical performance after 2 years for 10 non-remelted highly crosslinked PE cups compared to 16 conventional PE cups sterilized by gamma-in-air.Method Because of possible degradation by free radicals, we followed up both cohorts for 5 years (conventional PE) and 6 years (highly cross-linked PE).Result Mean (CI) proximal head penetration over the observation time was linear and measured 0.08 (0.02–0.13) mm for cross-linked PE and 0.42 (0.23–0.62) mm for conventional PE, and total penetration was 0.23 (0.1–0.35) mm and 0.75 (0.05–1.4) mm respectively. After subtracting creep, the annual wear for non-remelted highly cross-linked PE was below 6 µm. The cups had equally low migration and few radiolucencies.Interpretation The theoretical possibility of oxidation in non-remelted highly cross-linked PE may not show clinically. However, it may be that cemented cups with their thicker PE are more forgiving than metal-backed cups with thin PE moving in the locking mechanism. So far, we can conclude that the Crossfire highly crosslinked polyethylene cups performed very well clinically, with extremely low wear even after almost 6 years. This is reassuring, but care should be taken in extrapolating these results to other cross-linked PEs or uncemented cups where toughness of PE is more of an issue.

In Vivo Wear and Migration of Highly Cross-Linked Polyethylene Cups: A Radiostereometry Analysis Study

In 50 cemented hip arthroplasties, wear and migration of the polyethylene (PE) cups were measured with radiostereometric analysis for a period of 2 years. Twenty had a normal gamma-in-air–sterilized PE, another 20 had a PE sterilized with 30 000 Gy followed by heat stabilization (Duration; Stryker Orthopaedics, Mahwah, NJ), and 10 had highly cross-linked PE cups irradiated with 100 000 Gy (Crossfire; Stryker Orthopaedics). In the initial 2 months, head penetration (creep) was 63 μm on average for the 3 groups. From 2 to 24 months, the mean proximal head penetration (wear) was 156 μm for standard PE, 138 μm for stabilized PE ( P = .45), and 23 μm for highly cross-linked PE ( P < .001; analysis of variance). The low in vivo wear rate for highly cross-linked cups was not at the expense of higher migration or less favorable clinical outcome and looks promising.