An Uncemented Iso-Elastic Monoblock Acetabular Component: Preliminary Results

doi:10.1016/j.arth.2014.11.017

The Journal of Arthroplasty

Volume 30, Issue 4, April 2015, Pages 615-621

https://doi.org/10.1016/j.arth.2014.11.017 Get rights and content

Abstract

Little is known about the clinical application of highly cross-linked polyethylene (HXLPE) blended with vitamin E. This study evaluates an uncemented iso-elastic monoblock cup with vitamin E blended HXLPE. 112 patients were followed up for 2 years. 95.5% completed the follow-up. The mean VAS score for patient satisfaction was 8.8 and the mean Harris Hip Score was 94.2. In 7 cases initial gaps behind the cup were observed, which disappeared completely during follow-up in 6 cases. The mean femoral head penetration rate was 0.055 mm/year. No adverse reactions or abnormal mechanical behavior was observed with the short term use of vitamin E blended HXLPE. This study shows the promising performance of this cup and confirms the potential of vitamin E blended HXLPE.

Section snippets

Materials and Methods

This prospective case series was conducted at Diakonessenhuis Hospital Utrecht/Zeist, a medium size general hospital in the Netherlands. The local institutional review board approved the conduct of this study. All participating patients gave their full informed consent in writing. Between September 2009 and May 2011, a total of 112 patients (117 hips) were enrolled. Patients received a total hip arthroplasty at a mean of 35 days (range 0–163) after enrollment and were followed up for 2 years

Results

A total of 107 patients (112 hips) (95.5%) completed the 2-year follow-up. Four patients were lost to follow-up (3.6%) mainly due to poor general health and thus not being able to complete the follow-up. One patient had died (0.9%) because of acute respiratory distress syndrome due to pneumonia and cardiac decompensation at day 10 after surgery.

The mean VAS score for pain while resting decreased from a mean of 4.53 (range 0–9) at baseline to 0.72 (range 0–7) at 3 months follow-up. Subsequently

Discussion

Previous in-vitro studies have shown that vitamin E blended HXLPE has improved fatigue strength and is protected against oxidative embrittlement 7., 10., 12.. The material therefore seems to be ideal for the clinical application as a durable bearing in total hip arthroplasty. Still, little is known about the clinical application of vitamin E blended HXLPE. This study evaluated the short term clinical and radiological outcome and the femoral head penetration of vitamin E blended HXLPE in an

Acknowledgments

The institution of one or more of the authors (JJH, RE, SMvG and AG) has received funding from Mathys Ltd, Bettlach, Switzerland. We gratefully thank Liesbeth de Ruijter, MPA and Carla Jansen, NP for their contributions to the data collection. We also thank professor W.J.A. Dhert, MD, PhD for his review of the manuscript.

References (40)

D.A. Bichara et al.
Vitamin E-diffused highly cross-linked UHMWPE particles induce less osteolysis compared to highly cross-linked virgin UHMWPE particles in vivo
J Arthroplasty
(2014)
D. Pakvis et al.
A cementless elastic monoblock socket in young patients: a ten to 18-year clinical and radiological follow-up
Int Orthop
(2011)
M. Ihle et al.
The results of the titanium-coated RM acetabular component at 20 years: a long-term follow-up of an uncemented primary total hip replacement
J Bone Joint Surg (Br)
(2008)
S.M. Kurtz et al.
History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene
Clin Orthop Relat Res
(2011)
L. Bradford et al.
Wear and surface cracking in early retrieved highly cross-linked polyethylene acetabular liners
J Bone Joint Surg Am
(2004)
S.M. Kurtz et al.
Mechanical properties of retrieved highly cross-linked crossfire liners after short-term implantation
J Arthroplasty
(2005)
H.N. Pang et al.
Highly crosslinked polyethylene improves wear but not surface damage in retrieved acetabular liners
Clin Orthop Relat Res
(2014)
M. Beck et al.
Oxidation prevention with vitamin E in a HXLPE isoelastic monoblock pressfit cup—preliminary results
M.J. Kasser
Regulation of UHMWPE biomaterials in total hip arthroplasty
J Biomed Mater Res B Appl Biomater
(2013)
E. Oral et al.
Wear resistance and mechanical properties of highly cross-linked, ultrahigh-molecular weight polyethylene doped with vitamin E
J Arthroplasty
(2006)

P. Bracco et al.

Vitamin E-stabilized UHMWPE for total joint implants: a review

Clin Orthop Relat Res

(2011)

J.J. Halma et al.

Edge loading does not increase wear rates of ceramic-on-ceramic and metal-on-polyethylene articulations

J Biomed Mater Res B Appl Biomater

(2014)

R. Lerf et al.

Use of vitamin E to protect cross-linked UHMWPE from oxidation

Biomaterials

(2010)

B. Gasser

Biomechanical principles and studies

D. Pakvis et al.

A cementless, elastic press-fit socket with and without screws

Acta Orthop

(2012)

J.J. Halma et al.

Do monoblock cups improve survivorship, decrease wear, or reduce osteolysis in uncemented total hip arthroplasty?

Clin Orthop Relat Res

(2013)

C.H. Geerdink et al.

The determination of linear and angular penetration of the femoral head into the acetabular component as an assessment of wear in total hip replacement: a comparison of four computer-assisted methods

J Bone Joint Surg (Br)

(2008)

A.T. Kostakos et al.

Migration of the trabecular metal monoblock acetabular cup system

J Arthroplasty

(2010)

S.Y. Kim et al.

Total hip arthroplasty with the use of nonmodular cementless acetabular component

J Arthroplasty

(2005)

R. Elke et al.

Acetabular revision in total hip replacement with a press-fit cup

J Bone Joint Surg (Br)

(2003)

Cited by (10)

In Vivo Performance of Vitamin E Stabilized Polyethylene Implants for Total Hip Arthroplasty: A Review
2023, Journal of Arthroplasty
Citation Excerpt :
Reports of polyethylene-related complications were infrequent for VEPE, but included component wear [28,16] and cup/liner fracture [26,42–44], most of which were reported as single instances in case studies. A number of studies also reported the in vivo performance of VEPE to be independent of certain implant and patient factors including femoral head size [37,9,12,13,15,27] and patient activity (ie, University of California Los Angeles score) [10]. The influence of cup anteversion on FHP was less consistent between studies [21,30].
Vitamin E stabilization was introduced to improve the oxidative stability, wear resistance, and mechanical properties of highly crosslinked polyethylene (HXLPE). In this literature review, we asked: (1) How has vitamin E-stabilized HXLPE (VEPE) performed in vivo for total hip arthroplasty (THA) and how does it compare with conventional ultra-high molecular weight polyethylene (UHMWPE) and HXLPE without vitamin E; and (2) Is there an apparent difference in the clinical performance of VEPE created by blending versus diffusion?
We performed a systematic search of the literature according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines using PubMed and Embase. Included studies reported the in vivo behavior of VEPE in THA. We reviewed 41 studies.
For all studies that compared polyethylene with and without VE stabilization, outcomes for VEPE were either equivalent or superior to the control group (for HXLPE without VE and conventional UHMWPE controls, respectively). Hip insert wear rates were generally less than 0.1 mm/year and in most cases were less than 0.05 mm/year. No VEPE components were revised for osteolysis or adverse outcomes specific to VE incorporation.
Across the literature, we found that VEPE was reported to be clinically effective for THA applications, with much of the research indicating positive clinical outcomes and lower or equivalent wear rates compared to conventional UHMWPE and HXLPE controls without VE. Instances of early component fracture were reported, but have multiple potential causes. There is a gap in the literature for comparison of blended and diffused components, so the in vivo impact of VE incorporation method remains to be seen. Overall, this study provides a comprehensive summary of VEPE clinical performance for THA and may serve as a resource for future investigations.
Survivorship and Patient-Reported Outcomes of an Uncemented Vitamin E–Infused Monoblock Acetabular Cup: A Multicenter Prospective Cohort Study
2021, Journal of Arthroplasty
Citation Excerpt :
Indeed, medium-term follow-up of 22 such lucencies in a series of 343 patients suggested that the presence of such lucencies did not increase risk of cup failure [30]. It should be noted that the dome shape of the RM Pressfit Cup can result in a polar void occurring postimplantation [20], despite adequate mechanical fixation (see Fig. 7). These voids occur as a result of an intentional designed mismatch between the radius of curvature of the implant and the reamed acetabulum to create optimal keystone-like pressfit during implantation.
Addition of vitamin E to polyethylene is theorized to reduce the potential for oxidative wear in acetabular components. This paper presents a multicenter prospective cohort study that reports on outcomes from use of a Vitamin E–infused highly cross-linked polyethylene acetabular cup.
Patients were recruited across nine medical institutions. Clinical outcome measures recorded were the Harris Hip Score, visual analogue score for pain and satisfaction. Evidence of implant loosening or osteolysis was collected radiologically. Cup survival and reasons for revision in relevant cases were also recorded. Data collection was undertaken preoperatively, at 6-12 weeks, 6 months, 1 year, 2 years, and 5 years. A total of 675 patients were recruited, with 450 cases available at final review. Data regarding cup survival was available to 8 years and 9 months postoperatively.
Improvements in both the Harris Hip Score and visual analogue score for pain and satisfaction were recorded at all time points, with these being maintained through the length of follow-up. In total, 89% of cups were implanted within the Lewinnek safe zone. A lucent line was identified in one case, with no evidence of acetabular osteolysis observed throughout the follow-up period. Cup survival was 98.9% at 8 years and 9 months. No revisions for aseptic loosening were observed.
The use of a vitamin E–infused polyethylene acetabular cup demonstrates reassuring patient-reported outcomes, radiological measures, and cup survival at medium to long-term follow-up.
Wear and migration are not influenced by head size in a vitamin E-infused highly cross-linked polyethylene acetabular cup
2021, Orthopaedics and Traumatology: Surgery and Research
Citation Excerpt :
Our good results on VEPE acetabular cups are in line with other short- to midterm clinical data [7,13,22,28]. In particular, the mean Harris Hip Score we reported was better than that of other studies using 28 mm, 32 mm, or 36 mm heads at a comparable midterm follow-up [22,28,29]. This study's main strengths were its multicentre setup and the use of the widely accepted EBRA software.
Aseptic loosening and periprosthetic osteolysis are frequent complications in total hip arthroplasty requiring revision surgery. Highly cross-linked polyethylene (HXLPE) implants have improved wear resistance, permitting larger femoral heads. However, such implants may experience surface cracking, mechanical failure, and oxidative damage. Vitamin E-infused HXLPE (VEPE) implants were therefore developed to reduce oxidation without compromising mechanical strength. We addressed the following questions: (1) Does femoral head size affect the midterm annual polyethylene wear rates of VEPE acetabular cups? (2) Does femoral head size affect the midterm migration rates of VEPE acetabular cups? (3) Are clinical outcomes affected by femoral head size?
Annual wear rate, migration rate, and clinical outcomes of VEPE acetabular cups are independent of femoral head size.
This was a prospective, multicentre, observational study of patients that underwent total hip arthroplasty. Hips were grouped according to the size of femoral head implanted (28 mm, 32 mm, and 36 mm). We determined annual wear rate and migration rate of VEPE acetabular cups using the Einzel-Bild-Röntgen-Analyse software. Clinically, we assessed the Harris Hip Score and visual analog score for pain and satisfaction.
We followed 253 patients (267 hips) for a mean of 55.0 ± 20.6 months in the 28 mm, 46.2 ± 21.4 months in the 32 mm, and 43.8 ± 22.6 months in the 36 mm group. The annual wear rate was 0.025 mm per year from 1 year to the last follow-up and remained similar between the groups (p > 0.05). Also, mean two-dimensional migration rates did not exceed 0.05 mm from 2 years to the last follow-up and remained similar between the groups (p = 0.355). Finally, clinical outcomes also did not differ between the groups (p > 0.05). Two patients required revision surgery.
Femoral head size did not influence midterm annual wear rate, migration rate, and clinical outcomes of VEPE acetabular cups. Furthermore, wear and cup migration rates were below the reported values leading to osteolysis and aseptic loosening. Nevertheless, studies with extended follow-up periods will be necessary to confirm these results in the long term.
IV.
The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up
2021, BMC Musculoskeletal Disorders
Femoral head penetration in Vitamin-E polyethylene liner versus conventional liners in total hip arthroplasty: Systematic review and meta-analysis of randomised control trials
2021, SICOT-J
2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene
2020, Acta Orthopaedica

View all citing articles on Scopus

: The Conflict of Interest statement associated with this article can be found at http://dx.doi.org/10.1016/j.arth.2014.11.017.

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An Uncemented Iso-Elastic Monoblock Acetabular Component: Preliminary Results

Abstract

Section snippets

Materials and Methods

Results

Discussion

Acknowledgments

J Arthroplasty

A cementless elastic monoblock socket in young patients: a ten to 18-year clinical and radiological follow-up

Int Orthop

The results of the titanium-coated RM acetabular component at 20 years: a long-term follow-up of an uncemented primary total hip replacement

J Bone Joint Surg (Br)

History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene

Clin Orthop Relat Res

Wear and surface cracking in early retrieved highly cross-linked polyethylene acetabular liners

J Bone Joint Surg Am

Mechanical properties of retrieved highly cross-linked crossfire liners after short-term implantation

J Arthroplasty

Highly crosslinked polyethylene improves wear but not surface damage in retrieved acetabular liners

Clin Orthop Relat Res

Oxidation prevention with vitamin E in a HXLPE isoelastic monoblock pressfit cup—preliminary results

Regulation of UHMWPE biomaterials in total hip arthroplasty

J Biomed Mater Res B Appl Biomater

Wear resistance and mechanical properties of highly cross-linked, ultrahigh-molecular weight polyethylene doped with vitamin E

J Arthroplasty

Vitamin E-stabilized UHMWPE for total joint implants: a review

Clin Orthop Relat Res

Edge loading does not increase wear rates of ceramic-on-ceramic and metal-on-polyethylene articulations

J Biomed Mater Res B Appl Biomater

Use of vitamin E to protect cross-linked UHMWPE from oxidation

Biomaterials

Biomechanical principles and studies

A cementless, elastic press-fit socket with and without screws

Acta Orthop

Do monoblock cups improve survivorship, decrease wear, or reduce osteolysis in uncemented total hip arthroplasty?

Clin Orthop Relat Res

The determination of linear and angular penetration of the femoral head into the acetabular component as an assessment of wear in total hip replacement: a comparison of four computer-assisted methods

J Bone Joint Surg (Br)

Migration of the trabecular metal monoblock acetabular cup system

J Arthroplasty

Total hip arthroplasty with the use of nonmodular cementless acetabular component

J Arthroplasty

Acetabular revision in total hip replacement with a press-fit cup

J Bone Joint Surg (Br)