-
1.
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.
Tsikandylakis, G, Mortensen, KRL, Gromov, K, Mohaddes, M, Malchau, H, Troelsen, A
The bone & joint journal. 2021;(7):1206-1214
Abstract
AIMS: 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. METHODS 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. RESULTS 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. CONCLUSION 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 J 2021;103-B(7):1206-1214.
-
2.
Evaluation of in vivo wear of vitamin E-diffused highly crosslinked polyethylene at five years: a multicentre radiostereometric analysis study.
Galea, VP, Connelly, JW, Shareghi, B, Kärrholm, J, Sköldenberg, O, Salemyr, M, Laursen, MB, Muratoglu, O, Bragdon, C, Malchau, H
The bone & joint journal. 2018;(12):1592-1599
-
-
Free full text
-
Abstract
AIMS: The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure. PATIENTS AND METHODS A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery. RESULTS We observed similar bedding in one year postoperatively and wear two years postoperatively between the two types of liner. However, there was significantly more penetration of the femoral head in the ModXLPE cohort compared with the VEPE cohort five years postoperatively (p < 0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β = 0.22, p = 0.010) and metal (vs ceramic) femoral head (β = 0.21, p = 0.013). There was no association between increased wear and the development of radiolucency (p = 0.866) or PROMs. No patient had evidence of osteolysis. CONCLUSION Five years postoperatively, patients with VEPE (vs ModXLPE) and ceramic (vs metal) femoral heads had decreased wear. The rates of wear for both liners were very low and have not led to any osteolysis or implant failure due to aseptic loosening.
-
3.
VASO (Vitamin D and Arthroplasty Surgery Outcomes) study - supplementation of vitamin D deficiency to improve outcomes after total hip or knee replacement: study protocol for a randomised controlled feasibility trial.
Morrison, RJM, Bunn, D, Gray, WK, Baker, PN, White, C, Rangan, A, Rankin, KS, Reed, MR
Trials. 2017;(1):514
Abstract
BACKGROUND Vitamin D deficiency has been linked to poor outcomes after total hip replacement (THR) or total knee replacement (TKR), including lower patient-reported outcome measures (PROMs), peri-prosthetic infection and longer hospital stay. We present a randomised feasibility trial protocol designed to prospectively investigate the influence of vitamin D testing, and subsequent supplementation for deficiency, prior to THR/TKR. METHODS/DESIGN One hundred adult patients undergoing primary THR/TKR for osteoarthritis at two NHS hospital trusts in North East England will be recruited. Exclusion criteria include lack of mental capacity, revision surgery, participants already taking vitamin D/calcium supplements, or a known contraindication to vitamin D treatment. Participants will be ineligible for the trial if they have an estimated glomerular filtration rate < 30 ml/minute. We will measure patients' vitamin D levels at baseline, and those identified as deficient (vitamin D < 50 nmol/L) will be randomised to receive either vitamin D supplementation or no supplementation prior to, and for 6 months following, surgery. Patients with a normal vitamin D level (≥50 nmol/L) will receive no supplementation. Vitamin D levels will be rechecked on the day of surgery and again at 6 months. Patients will also complete a lifestyle questionnaire, as well as the Oxford hip or knee and EQ-5D-3 L PROM questionnaires, at baseline and at 6 months following surgery. The aims are to determine the feasibility of the methodology and to gather data to inform the conduct of a future, larger trial to investigate if supplementation with vitamin D, in those who are deficient, prior to THR/TKR improves outcomes as measured by PROM scores. DISCUSSION Previous reports have measured vitamin D levels and correlated this to outcome, but we can find no randomised trial in which researchers investigated the effect of supplementation. The aim of this trial is to determine if vitamin D deficiency is a modifiable risk factor for poor outcome after THR/TKR. TRIAL REGISTRATION ISRCTN Registry, ISRCTN14533082 . Registered on 3 April 2017.
-
4.
3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement.
Sillesen, NH, Greene, ME, Nebergall, AK, Huddleston, JI, Emerson, R, Gebuhr, P, Troelsen, A, Malchau, H
Hip international : the journal of clinical and experimental research on hip pathology and therapy. 2016;(1):97-103
Abstract
PURPOSE Preclinical studies of vitamin E diffused highly cross-linked polyethylene (E-XLPE) has shown enhanced mechanical properties with less wear. The purpose of our study was to document the early clinical outcome of E-XLPE to ensure, for the safety of patients, that there are no unforeseen early adverse events from using this new biomaterial. METHODS The enrolled patients (n = 977) have received either a porous titanium coated or porous plasma sprayed acetabular shell with either a E-XLPE liner or a medium cross-linked (AXL) liner. At each follow-up 5 patient-reported outcome measures (PROMs) were completed: Harris Hip Score, Case Mix Indicator, UCLA Activity Score, SF-36, and EQ-5D. Radiographs were measured for cup and stem position, as well as femoral head penetration into the liner (wear). Postoperative complications and revisions were collected. RESULTS At 3 years follow-up, there were 13 revisions due to: 4 periprosthetic fractures; 1 sepsis; 6 instabilities; and 2 implant mismatches at surgery. Wear of the hip implant, calculated by software analysis of pelvis x-rays, from the postoperative interval to 3 years showed a liner penetration rate of 0.027 mm/year for AXL and 0.005 mm/year for E-XLPE with no significant difference between the 2 (p = 0.24). Improvement was seen in all PROMs from the preoperative interval to 3 years after surgery (p<0.0001). CONCLUSIONS Early follow-up of the E-XLPE and AXL liners show low penetration. PROMs indicate improvement after total hip arthroplasty in functionality and quality of life across the centers. We have not observed any early in vivo adverse effects from diffusing the liners with vitamin E. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00545285.
-
5.
Three Year RSA Evaluation of Vitamin E Diffused Highly Cross-linked Polyethylene Liners and Cup Stability.
Sillesen, NH, Greene, ME, Nebergall, AK, Nielsen, PT, Laursen, MB, Troelsen, A, Malchau, H
The Journal of arthroplasty. 2015;(7):1260-4
Abstract
Vitamin E diffusion into highly cross-linked polyethylene (E-XLPE) is a method for enhancing oxidative stability of acetabular liners. The purpose of this study was to evaluate in vivo penetration of E-XLPE using radiostereometric analysis (RSA). Eighty-four hips were recruited into a prospective 10-year RSA. This is the first evaluation of the multicenter cohort after 3-years. All patients received E-XLPE liners (E1, Biomet) and porous-titanium coated cups (Regenerex, Biomet). There was no difference (P=0.450) in median femoral head penetration into the E-XLPE liners at 3-years comparing cobalt-chrome heads (-0.028mm; inter-quartile range (IQR) - 0.065 to 0.047) with ceramic heads (-0.043mm, IQR - 0.143to0.042). The 3-year follow-up indicates minimal E-XLPE liner penetration regardless of head material and minimal early cup movement.
-
6.
More than 50% reduction of wear in polyethylene liners with alumina heads compared to cobalt-chrome heads in hip replacements: a 10-year follow-up with radiostereometry in 43 hips.
Dahl, J, Snorrason, F, Nordsletten, L, Röhrl, SM
Acta orthopaedica. 2013;(4):360-4
Abstract
BACKGROUND AND PURPOSE Excessive wear of acetabular liners in hip replacements may lead to osteolysis and cup loosening. Different head materials are currently used. We measured differences in wear between alumina and cobalt-chrome heads with the same polyethylene liner. PATIENTS AND METHODS 39 patients (43 hips) with osteoarthritis were included in a study with 10-year follow-up. Wear was measured as proximal and 3D penetration of the head in the liner with radiostereometry (RSA). All the patients were followed clinically with Harris hip score (HHS) for up to 10 years. Radiolucent lines and osteolytic lesions were assessed on plain radiographs. RESULTS With alumina heads, proximal wear (95% CI) after 10 years was 0.62 (0.44-0.80) mm as compared to 1.40 (1.00-1.80) mm in the cobalt-chrome group. For 3D wear, the results were 0.87 (0.69-1.04) mm for alumina heads and 1.78 (1.35-2.21) mm for cobalt-chrome heads. Median (range) HHS was 98 (77-100) in the alumina group and it was 93 (50-100) in the cobalt-chrome group (p = 0.01). We found no difference in osteolysis between the groups. INTERPRETATION We found better wear properties with alumina heads than with cobalt-chrome heads. We recommend the use of alumina heads in patients in whom a high wear rate might be anticipated.
-
7.
The effect of different bearing surfaces on metal ion levels in urine following 28 mm metal-on-metal and 28 mm metal-on-polyethylene total hip arthroplasty.
Tiusanen, H, Mäkelä, K, Kiilunen, M, Sarantsin, P, Sipola, E, Pesola, M
Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society. 2013;(3):197-203
Abstract
BACKGROUND AND AIMS Recent advancements in manufacturing technology have enabled more precise tolerances and surface finishes using metal-on-metal bearing surfaces in total hip arthroplasty. The aim of this study was to compare the level of metal ions in urine after implantation of a 28-mm metal-on-metal bearing manufactured from high-carbon wrought alloy and a 28-mm metal-on-polyethylene bearing. MATERIAL AND METHODS A total of 92 total hip arthroplasty patients were prospectively randomized into two groups: those receiving metal-on-metal bearings and those receiving metal-on-polyethylene bearings. Chromium, cobalt, and molybdenum ion levels in urine were measured preoperatively and at 1 year and 2 years postoperatively. RESULTS In the metal-on-polyethylene group, there was a slight increase in mean chromium and cobalt concentrations at 2-year follow-up compared to the preoperative level (p = 0.02 for both chromium and cobalt). In the metal-on-metal group, there was a 15-fold increase in chromium and a 26-fold increase in cobalt at 2-year follow-up compared to the preoperative level (p < 0.001 for both chromium and cobalt). However, the quantity of chromium and cobalt in urine from the metal-on-metal group was not higher at 2-year follow-up than at 1-year follow-up (p = 0.5 and p = 0.6, respectively). CONCLUSIONS The 28-mm metal-on-metal bearings yield chromium and cobalt concentrations in urine that can be higher than those recommended for occupational exposure. However, our results also indicate that a steady state in wear and ion production using metal-on-metal total hip arthroplasty can occur.
-
8.
Component positioning in primary total hip replacement: a prospective comparative study of two anterolateral approaches, minimally invasive versus gluteus medius hemimyotomy.
Mouilhade, F, Matsoukis, J, Oger, P, Mandereau, C, Brzakala, V, Dujardin, F
Orthopaedics & traumatology, surgery & research : OTSR. 2011;(1):14-21
Abstract
INTRODUCTION One factor of implant survivorship in total hip replacement (THR) is the quality of implant choice and positioning. The purported advantages of minimally invasive approaches are faster recovery, shorter hospital stay and less per-operative blood loss. On the other hand, there have been many reports of higher complication rates, and doubts as to the quality of implant positioning. HYPOTHESIS The quest to minimize tissue damage is at the cost of THR positioning quality. OBJECTIVES To assess implant positioning in a prospective comparative continuous multicenter series. PATIENTS AND METHODS Between 2008 and 2009, a prospective comparative study was conducted on a continuous series of 141 THRs. Ninety-two were performed in two centers, using a minimally invasive Watson-Jones approach; the other 49, performed in a 3rd center, used an anterolateral approach with anterior hemimyotomy. The surgeons were in all cases experienced in their technique. Short-term follow-up comprised clinical and functional (Postel Merle d'Aubigné (PMA), Harris, SF12, WOMAC) and biological assessment (serum creatine phosphokinase (CPK), myoglobinemia, hematocrit) and analysis of complications and of implant positioning on X-ray and CT-scan. RESULTS On the Watson-Jones approach, surgery time was longer; day-1 analgesic administration was lower; PMA, Harris and WOMAC scores were better at 6 weeks; and CPK levels were lower at 24 and 48hours. There were no significant differences on the other clinical and biological criteria. Implant positioning analysis revealed significantly greater combined anteversion and greater variation in acetabular inclination mean with the Watson-Jones approach, but no differences in cup positioning, femoral stem positioning, or limb length discrepancy. DISCUSSION The minimally invasive Watson-Jones approach provided faster recovery and less muscular damage. However, implant positioning was less precise in terms of acetabular cup inclination. LEVEL OF EVIDENCE Level III. Prospective, comparative, non-randomized.
-
9.
Use of an alumina-on-alumina bearing system in total hip arthroplasty for osteonecrosis of the hip.
Seyler, TM, Bonutti, PM, Shen, J, Naughton, M, Kester, M
The Journal of bone and joint surgery. American volume. 2006;:116-25
Abstract
BACKGROUND The results of total hip arthroplasty in patients with osteonecrosis of the femoral head are not always optimal. The use of alumina-on-alumina interfaces in young and active patients may decrease wear and lower the rate of aseptic loosening of the implant and appears to be an attractive alternative to the use of conventional cobalt-chromium-on-polyethylene bearings. The purpose of this study was to evaluate the safety and efficacy of the alumina-on-alumina bearing in patients with osteonecrosis and to compare this group of patients to a group of similarly treated patients with osteoarthritis and a group of patients who received conventional cobalt-chromium-on-polyethylene bearings. METHODS Patients were selected from a United States Investigational Device Exemption multicenter prospective randomized clinical study that was initiated in 1996. Seventy patients with osteonecrosis of the femoral head (seventy-nine hips) received a cementless alumina-on-alumina bearing system and were directly matched to seventy-six patients with osteoarthritis of the hip (seventy-nine hips) who were managed with the same implant. Both groups were compared with twenty-five patients (twenty-six hips) with osteonecrosis and twenty-five patients (twenty-six hips) with osteoarthritis who were managed with a cementless cobalt-chromium-on-polyethylene bearing system. All patients received a cementless hydroxyapatite-coated femoral stem and were followed both clinically and radiographically. RESULTS The clinical outcomes for alumina-on-alumina bearings were similar for both osteonecrotic and osteoarthritic hips. The seven-year survival probability was 95.5% for the osteonecrotic hips and 89.4% for the osteoarthritic hips in the alumina-on-alumina bearing group and 92.3% for the osteonecrotic hips and 92.9% for the osteoarthritic hips in the cobalt-chromium-on-polyethylene bearing group. At the time of the most recent follow-up, the mean Harris hip score was 96 points for both the osteonecrotic and the osteoarthritic hips in the alumina-on-alumina group and 96 points for the osteonecrotic hips and 97 points for the osteoarthritic hips in the cobalt-chromium-on-polyethylene bearing group. CONCLUSIONS The results of the use of alumina-on-alumina and cobalt-chromium-on-polyethylene bearings in cementless standard total hip implants in patients with osteonecrosis and osteoarthritis were comparable. The low revision rate for the alumina-on-alumina bearing is encouraging and offers a promising option for younger, more active patients who have this challenging disease. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions to Authors on jbjs.org for a complete description of levels of evidence.
-
10.
Mid-term results of a polyethylene-free metal-on-metal articulation.
Lombardi, AV, Mallory, TH, Cuckler, JM, Williams, J, Berend, KR, Smith, TM
The Journal of arthroplasty. 2004;(7 Suppl 2):42-7
Abstract
Beginning in December 1995, 193 patients (195 hips) were enrolled into this prospective, randomized, controlled multicenter investigational device exemption study. Ninety-eight patients (99 hips) with 46 polyethylene liners and 53 metal liners had minimum 5-year follow-up (mean, 5.7 years). Average follow-up, Harris hip score improvement, and radiographic analysis were not statistically different between groups. No stress shielding or osteolysis was observed in either group. Three polyethylene liners and no metal liners had acetabular radiolucencies <1 mm in 1 or more zones. There have been no device-related complications, no acetabular revisions performed, and none pending in either group. Based on these mid-term results, the authors conclude that a metal-on-metal articulation represents a viable alternative in young, high-demand, active patients.