48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05).Introduction
Methods
The large diameter mobile polyethylene liner of the dual mobility implant provides increased resistance to hip dislocation. However, a problem specific to the dual mobility system is intra-prosthetic dislocation (IPD), secondary to loss of the retentive rim, causing the inner head to dissociate from the polyethylene liner. We hypothesized that impingement of the polyethylene liner with the surrounding soft-tissue inhibits liner motion, thereby facilitating load transfer from the femoral neck to the liner and leading to loss of retentive rim over time. This mechanism of soft-tissue impingement with the liner was evaluated via cadaver experiments, and retrievals were used to assess polyethylene rim damage. Total hip arthroplasty was performed on 10 cadaver hips using 3D printed dual mobility components. A metal wire was sutured to the posterior surface (underside) of the iliopsoas, and metal wires were embedded into grooves on the outer surface of the liner and inner head to identify these structures under fluoroscopy. Tension was applied to the iliopsoas to move the femur from maximum hyperextension to 90° of flexion for the purpose of visualizing the iliopsoas and capsule interaction with the mobile liner. The interaction of the mobile liner with the iliopsoas was studied using fluoroscopy and direct visual observation. Fifteen retrieved dual mobility liners were assessed for rim edge and rim chamfer damage. Rim edge damage was defined as any evidence of contact, and rim chamfer damage was classified into six categories: impact ribs on the chamfer surface, loss of machining marks, scratching or pitting, rim deformation causing a raised lip, a rounded rim edge, or embedded metal debris.Introduction
Methods
Osteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decrease oxidative stability. 58 patients (64 observed hips), all with osteoarthritis, gave informed consent to participate in a 5 year RSA study. Each patient received a VEPE liner, a Regenerex™ acetabular shell, and an uncemented stem with either a 32mm or 36 mm cobalt chrome femoral head. Tantalum beads were inserted into the VEPE, the pelvic and the femoral bone to measure head penetration into the polyethylene, and shell and stem stability over time, using RSA. RSA radiographs were scheduled immediately postoperatively (up to 6 weeks) and 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks nonparametric test was used to determine if changes in penetration or migration were significant over time at p≤0.05.Introduction
Methods
RSA is widely accepted as a precise method to asses wear and migration early in the postoperative period. In traditional RSA, one segment defines both the acetabular shell and the polyethylene liner. However, inserting beads into the liner permits employment of the shell and liner as two separate segments, thus enabling distinct analysis of the precision of three measurement methods in determining wear and acetabular shell migration. The purpose of this The UmRSA program was used to analyze the double examinations of 51 hips to determine if there was a difference in precision among 3 measurement methods: the shell only, the liner only, and the shell + liner combined segment. Tantalum beads were inserted into the liner and pelvic bone surrounding the shell intraoperatively for the purpose of RSA. Polyethylene wear was measured using point motion of the center of the head with respect to 3 different segments: 1) liner only, 2) the shell only and, 3) shell + liner segment. Cup stability was measured by segment motion comparing the stable pelvic segment to 1) the liner segment, 2) the shell only segment, and 3) the shell + liner segment. The Wilcoxon paired signed-ranks test was used to determine differences in condition number and bead counts among the 3 measurement methods (p ≤0.05).Introduction
Methods
In young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, crosslinked polyethylene liners and either titanium or tantalum shells. Early femoral implant stability is essential to long-term success in total hip replacement. Radiostereometric analysis (RSA) provides precise measurements of micromotion of the stem relative to the femur that are otherwise not detectable by routine radiographs. This study characterised micromotion of a tapered, cementless femoral stem and tantalum porous-coated vs. titanium acetabular shells in combination with highly cross-linked UHMWPE or conventional polyethylene liners using radiostereometric analysis (RSA) for 5 years following THR.Summary Statement
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. 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.Introduction
Methods
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.
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.
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.
