Cost-utility Analysis of Anterior Cervical Discectomy and Fusion for Cervical Spondylosis Patients Comparing Polyetheretherketone Versus Tricortical Iliac Crest Bone Graft.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To perform a cost-utility analysis and to investigate the clinical outcomes and patient's quality of life after anterior cervical discectomy and fusion (ACDF) to treat cervical spondylosis compared between fusion with polyetheretherketone (PEEK) and fusion with tricortical iliac bone graft (IBG) in Thailand. SUMMARY OF BACKGROUND DATA: ACDF is one of the standard treatments for cervical spondylosis. The fusion material options include PEEK and tricortical IBG. No previous studies have compared the cost-utility between these 2 fusion material options. PATIENTS AND METHODS: Patients with cervical spondylosis who were scheduled for ACDF at Siriraj Hospital (Bangkok, Thailand) during 2019-2020 were prospectively enrolled. Patients were allocated to the PEEK or IBG fusion material group according to the patient's choice of fusion material. EuroQol-5 dimensions 5 levels and relevant costs were collected during the operative and postoperative periods. A cost-utility analysis was performed using a societal perspective. All costs were converted to 2020 United States dollars (USD), and a 3% discount rate was used. The outcome was expressed as the incremental cost-effectiveness ratio. RESULTS: Thirty-six patients (18 ACDF-PEEK and 18 ACDF-IBG) were enrolled. Except for Nurick grading, there was no significant difference in patient baseline characteristics between groups. The average utility at 1 year after ACDF-PEEK and ACDF-IBG were 0.939 ± 0.061 and 0.798 ± 0.081, respectively ( P < 0.001). The total lifetime cost of ACDF-PEEK and ACDF-IBG was 83,572 USD and 73,329 USD, respectively. The incremental cost-effectiveness ratio of ACDF-PEEK when compared with that of ACDF-IBG showed a gain of 4468.52 USD/quality-adjusted life-years, which is considered cost-effective at the Thailand willingness-to-pay threshold of 5115 USD/quality-adjusted life-year gained. CONCLUSIONS: ACDF-PEEK was found to be more cost-effective than ACDF-IBG for treating cervical spondylosis in Thailand. LEVEL OF EVIDENCE: Level II.

In vitro and in silico assessment of new beta amino ketones with antiplasmodial activity.

BACKGROUND: Based on the current need for new drugs against malaria, our study evaluated eight beta amino ketones in silico and in vitro for potential antimalarial activity. METHODS: Using the Brazilian Malaria Molecular Targets (BraMMT) and OCTOPUS® software programs, the pattern of interactions of beta-amino ketones was described against different proteins of P. falciparum and screened to evaluate their physicochemical properties. The in vitro antiplasmodial activities of the compounds were evaluated using a SYBR Green-based assay. In parallel, in vitro cytotoxic data were obtained using the MTT assay. RESULTS: Among the eight compounds, compound 1 was the most active and selective against P. falciparum (IC50 = 0.98 µM; SI > 60). Six targets were identified in BraMMT that interact with compounds exhibiting a stronger binding energy than the crystallographic ligand: P. falciparum triophosphate phosphoglycolate complex (1LYX), P. falciparum reductase (2OK8), PfPK7 (2PML), P. falciparum glutaredoxin (4N0Z), PfATP6, and PfHT. CONCLUSIONS: The physicochemical properties of compound 1 were compatible with the set of criteria established by the Lipinski rule and demonstrated its potential as a drug prototype for antiplasmodial activity.

Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan.

OBJECTIVE: To compare the real-world effectiveness and costs of eribulin to those of capecitabine in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. METHODS: This study extracted data from the Health and Welfare Database in Taiwan to identify MBC patients, and then eribulin and capecitabine users were matched at a 1:1 ratio by age, residential region, Charlson Comorbidity Index score, and molecular subtype of BC cell. The overall survival (OS) and time-to-treatment discontinuation (TTD) curves were plotted using the Kaplan-Meier method. Healthcare utilization and costs between the two groups were compared. RESULTS: A total of 24,550 MBC patients were identified, and 298 patients were enrolled in each group after matching. The median OS was 11.8 months for eribulin (95%CI: 11.5-13.5 months) and 15.2 months for capecitabine (95%CI: 15.3-17.9 months; HR = 1.7, p < 0.0001). The median TTD was 4.0 months for eribulin and 6.6 months for capecitabine (HR = 1.6; p < 0.0001). No significant difference was found between the two groups in patients with >4 prior chemotherapy agents (OS: HR 1.1, 95%CI 0.8-1.5; TTD: HR 1.2, 95%CI 0.9-1.7). The total healthcare costs per patient during the treatment period were NT$580,523.8 for eribulin versus NT$497,223.8 for capecitabine (p < 0.0001), and total medication costs were NT$438,335.8 and NT$348,438.4 (p < 0.0001), respectively. CONCLUSION: Although eribulin showed an attenuated effect in the real-world setting in Taiwan, it may serve as an alternative for capecitabine in a heavy pretreated population. The total healthcare and medication costs were found to be higher with eribulin treatment.

An economic evaluation of eribulin for advanced breast cancer treatment based on the Southeast Netherlands advanced breast cancer registry.

Background: In 2013, eribulin was reimbursed under a coverage with evidence development (CED) as third or later chemotherapy line for advanced breast cancer (ABC) patients in the Netherlands because of uncertain cost effectiveness. In 2016, the final decision of reimbursing eribulin was taken without considering the evidence collected during CED research. We analysed the cost effectiveness of eribulin versus non-eribulin chemotherapy, using real-world data.Methods: A three health states (progression-free, progressed disease, dead) partitioned survival model was developed. The SOuth East Netherlands Advanced BREast Cancer (SONABRE) registry informed the effectiveness and costs inputs. Health state utility values were obtained from the literature. Incremental cost-effectiveness ratio (ICER) between the eribulin and matched non-eribulin chemotherapy was estimated. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed. The financial risk (i.e., the expected value of perfect information (EVPI) plus the expected monetary loss (eML) associated with reimbursing eribulin) and budget impact associated with reimbursing eribulin were calculated.Results: Eribulin led to higher health benefits (0.07 quality-adjusted life year (QALY)) and costs (€15,321) compared with non-eribulin chemotherapy. This resulted in an ICER of €220,608. At a €80,000 per QALY threshold, the risk of reimbursing eribulin was €9,791 per patient (EVPI €13, eML €9,778). Scaled up to the Dutch population, the estimated annual budget impact was €1.9 million and the annual risk of reimbursing eribulin was €2.7 million.Conclusion: From a Dutch societal perspective, eribulin is not cost effective when considering its list price as third and later chemotherapy line for ABC patients.

Costs associated with Eribulin treatment for patients with metastatic breast cancer in a comprehensive cancer center in France.

BACKGROUND: There is no standard recommendation for metastatic breast cancer treatment (MBC) after two chemotherapy regimens. Eribulin (Halaven®) has shown a significant improvement in overall survival (OS) in this setting. Its use may however be hampered by its cost, which is up to three times the cost of other standard drugs. We report the clinical outcomes and health care costs of a large series of consecutive MBC patients treated with Eribulin. METHODS: A monocentric retrospective study was conducted at Institut Curie over 1 year (August 2012 to August 2013). Data from patient's medical records were extracted to estimate treatment and outcome patterns, and direct medical costs until the end of treatment were measured. Factors affecting cost variability were identified by multiple linear regressions and factors linked to OS by a multivariate Cox model. RESULTS: We included 87 MBC patients. The median OS was 10.7 months (95%CI = 8.0-13.3). By multivariate Cox analysis, independent factors of poor prognosis were an Eastern Cooperative Oncology Group (ECOG) performance status of 3, a number of metastatic sites ≥ 4 and the need for hospitalization. Per-patient costs during whole treatment were €18,694 [CI 95%: 16,028-21,360], and €2581 [CI 95%: 2226-3038] per month. Eribulin administration contributed to 79% of per-patient costs. CONCLUSIONS: Innovative and expensive drugs often appear to be the main cost drivers in cancer treatment, particularly for MBC. There is an urgent need to assess clinical practice benefits.

[Efficacy, safety and cost of eribulin in patients with metastatic breast cancer]. / Efficacité, tolérance et coût de l'éribuline chez des patientes présentant un cancer du sein métastatique.

Eribulin gained its approval in March 2011 for the treatment of patients with locally advanced or metastatic breast cancer (MBC) whose disease has progressed despite anthracycline and taxane-containing regimens. This study retrospectively assessed the efficacy, safety and cost of this treatment for all patients with MBC treated by eribulin in Franche-Comté. Ninety-four patients received eribulin between July 2006 and October 2013. The median age was 62 years (35-83). Median overall survival was 10.3 months [95% CI: 7.6 to 17.9]. Median progression-free-survival was 3.8 months [95% CI: 2.9 to 5.0]. Clinical benefit was obtained in 55% evaluable patients [95% CI: 43.1 to 66.9] by RECIST criteria. Most common grade 3-4 adverse events (AEs) were neutropenia (38%), asthenia (10%) and peripheral neuropathy (7%). Median cost of the treatment was 9767 € per patient (6344-17,517). This analysis found similar results to the EMBRACE study despite less selected population. A medico-economic evaluation cost-utility type would assess the effectiveness of this strategy compared to standard treatments.

Eribulin for the treatment of advanced or metastatic breast cancer: a NICE single technology appraisal.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of eribulin (Eisai Ltd) to submit evidence for the clinical and cost effectiveness of eribulin as treatment for patients with locally advanced or metastatic breast cancer (LABC/MBC) pre-treated with at least two chemotherapy regimens. This article summarizes the review of evidence by the Evidence Review Group (ERG) and provides a summary of the NICE Appraisal Committee's (AC's) decision. The clinical evidence was derived from a multi-centred, open-label, randomized, phase III study comparing eribulin with treatment of physician's choice (TPC) in 762 patients with LABC/MBC. Clinical effectiveness results were submitted for two populations: the overall intention-to-treat (ITT) population and a subset (n = 488) that included only patients from North America, Western Europe and Australia (Region 1). For the primary endpoint of overall survival (OS), a primary analysis (after 55 % of patients had died) and an updated analysis (after 77 % of patients had died) were conducted. In the ITT population, treatment with eribulin was associated with a significant improvement in median OS compared with TPC in both primary [difference in median OS 2.5 months; hazard ratio (HR) 0.81, 95 % confidence interval (CI) 0.66-0.99] and updated analyses (2.7 months; HR 0.81, 95 % CI 0.67-0.96). A statistically significant improvement in progression-free survival (PFS) was reported for eribulin compared with TPC when assessed by the investigator (difference in median PFS 1.48 months; HR 0.76, 95 % CI 0.64-0.90), but not when assessed by the ERG (1.44 months; HR 0.87, 95 % CI 0.71-1.05). Gains in OS were greater for Region 1 patients than for the ITT population (3.1 vs. 2.7 months). Health-related quality of life (HRQoL) data suggested a benefit for eribulin responders, but was based on phase II studies. In the eribulin arm, serious adverse events included febrile neutropenia (4.2 %) and neutropenia (1.8 %), with peripheral neuropathy being the most common reason for treatment discontinuation. The manufacturer's economic evaluation using Patient Access Scheme costs reported a base-case incremental cost-effectiveness ratio (ICER) for eribulin versus TPC (Region 1) of £46,050 per quality-adjusted life year gained (corrected to £45,106 when an erroneous data entry was removed). The ERG's revised ICERs were £61,804 for Region 1 and £76,110 for the overall population. The AC concluded that the evidence had not demonstrated sufficient benefit in OS, cost effectiveness or HRQoL and that eribulin was not recommended for use in this patient group.

Activity of eribulin mesylate in heavily pretreated breast cancer granted access via the Cancer Drugs Fund.

AIM: Eribulin mesylate is a synthetic analog of halichondrin B and is licensed for the treatment of patients with locally advanced or metastatic breast cancer that has progressed following treatment with anthracyclines and taxanes. It was not deemed to be cost effective based on a cost analysis by the National Institute for Health and Care Excellence in England and therefore it is not funded routinely by the National Health Service. The establishment of the Cancer Drugs Fund in England subsequently enabled access. As with any new chemotherapy drug that enters clinical practice for metastatic breast cancer (MBC) it is often used in heavily pretreated patients and the experience in a routine clinical setting can differ from that in a clinical study. We therefore present the experience of the first 25 cases treated at our institution via the Cancer Drugs Fund. MATERIALS & METHODS: A total of 25 patients were treated and in the 22 assessable cases the objective response rate was 18% (four out of 22), with a clinical benefit rate of 41.0% (9 out of 22). RESULTS: The median time-to-progression and overall survival were 4.08 months and 5.89 months, respectively. There was a significant difference in clinical benefit rate (odds ratio: 0.065; 95% CI: 0-0.529; p = 0.0055), as well as time-to-progression (hazard ratio: 9.18; 95% CI: 2.26-37.38; p = 0.002 adjusted for age at diagnosis and interval between initial MBC diagnosis and commencing eribulin) favoring those patients who had not been rechallenged. There was no significant difference in overall survival (hazard ratio: 1.16; 95% CI: 0.44-3.05; p = 0.770 adjusted for age at diagnosis and interval between initial diagnosis of MBC and commencing eribulin). CONCLUSION: Eribulin mesylate shows clinical activity; however, there appears to be differences in terms of benefit in patients based on whether patients have been rechallenged with an anthracycline and/or a taxane. These data require confirmation in larger patient groups.

[Clinical efficacy and safety assessment of eribulin monotherapy in patients with metastatic breast cancer - a single- institute experience].

Eribulin mesylate, a novel microtubule inhibitor with a unique mechanism of action, was approved in Japan in April 2011 for the treatment of metastatic breast cancer patients who had been administered at least two prior chemotherapeutic agents. Here, we present a retrospective review of data from 27 patients who received eribulin monotherapy in our hospital. The overall response rate and clinical benefit rate were 25. 9% and 29. 6%, respectively, and the median progression-free survival was 9. 9 weeks(95% CI: 3. 5-16. 2 weeks). The toxicities of treatment were tolerable and manageable; responses were lower in patients who were triple negative subtype, and higher in patients who had responded to prior taxane treatment. The relative dose intensity of our data indicates that appropriate modification of dose and schedule may be an important part of eribulin monotherapy.

A cost effectiveness study of eribulin versus standard single-agent cytotoxic chemotherapy for women with previously treated metastatic breast cancer.

Eribulin was FDA approved in 2012 as a treatment for patients with MBC who have previously received at least two prior chemotherapy regimens. The aim of this analysis was to assess the cost effectiveness of eribulin versus the three most commonly utilized drugs (TPC) in the EMBRACE trial: vinorelbine, gemcitabine, and capecitabine (X); and to other branded FDA approved drugs: ixabepilone (I), liposomal-doxorubicin (D), and nab-paclitaxel. We created a decision-analytical and a Markov model using clinical data from the EMBRACE trial. Health utilities were derived from the published literature. Costs for drug acquisition, physician visits, and laboratory tests were obtained from Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2012 USD. Life-years saved (LY), quality-adjusted life years (QALY), and incremental cost effectiveness ratio (ICER) were calculated. Eribulin added 0.208 LY and 0.119 QALY with an incremental cost over TPC of $25,458, and therefore an ICER of $213,742 per QALY. The main drivers of the model were drug cost, PFS, OS, and health utility values. The results of the model were robust in sensitivity analyses. Relative to I, D, A, and X, the ICER for eribulin was $76,823, $109,283, $129,773, and $167,267, respectively. Even with a more contemporary willingness-to-pay threshold of approximately $120,000 per QALY, eribulin was not found to be cost effective in the treatment of MBC relative to TPC; relative to some more expensive branded drugs, eribulin appears to be cost effective.

A phase I, open-label, single-arm study for QT assessment of eribulin mesylate in patients with advanced solid tumors.

BACKGROUND: Several cancer therapies can prolong cardiac repolarization. This study assessed the potential of eribulin to affect cardiac repolarization in patients with advanced solid tumors. METHODS: In this Phase I, open-label, single-arm study, patients received eribulin mesylate (1.4 mg/m(2); Days 1 and 8 of a 21-day cycle). The primary objective was to assess the effect of eribulin on the QTcF pre- and post-infusion; QTcF and QTcNi were compared for ability to remove heart-rate dependence of the QT interval. Relationship between concentration of eribulin and ΔQTc was explored using linear mixed-effects analysis. Secondary objectives explored pharmacokinetics, safety, and tolerability. RESULTS: Twenty-six patients were enrolled. QTcNi was more effective than QTcF in correcting for heart-rate dependency of the QT interval. On Day 1, mean ΔQTcNi were ~0 at all timepoints. An apparent time-dependent increase in ΔQTc was observed: on Day 8, changes from baseline were larger and more variable, without clear relation to plasma levels of eribulin. Day 8 predose ΔQTcNi was 5 ms, post-infusion mean values ranged from 2 to 9 ms (largest mean ΔQTcNi at 6 h). No new or unexpected toxicities were reported. CONCLUSION: Eribulin demonstrated an acceptable safety profile and a minor prolongation of QTc not expected to be of clinical concern in oncology patients.

Eribulin mesylate: a novel halichondrin B analogue for the treatment of metastatic breast cancer.

PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy, safety, and administration of eribulin in patients with metastatic breast cancer are reviewed. SUMMARY: Classical chemotherapeutic agents for breast cancer have dominated treatment regimens even in the era of targeted therapy. Disease progression through these agents is often due to the development of resistance or lack of efficacy with these agents. Recently, a new nontaxane agent, eribulin mesylate, was approved for the treatment of metastatic breast cancer in patients who have received at least two prior chemotherapeutic agents. Eribulin is a member of a new class of synthetic cytotoxic agents derived from the Japanese sea sponge Halichondria okadai. Eribulin differs from other antimicrotubule agents in that it can bind to the microtubule cap and inhibit tubulin polymerization, leading to microtubule arrest. In Phase II clinical trials, eribulin demonstrated activity in extensively pretreated patients who had previously received an anthracycline, taxane, and capecitabine and had shown disease progression within the last six months of treatment. In a pivotal Phase III clinical trial of heavily pre-treated patients, patients who received eribulin versus the physician's treatment of choice showed a significant increase in overall and progression-free survival. Eribulin has a manageable adverse-effect profile, consisting mainly of neutropenia and fatigue. Eribulin has been associated with a low incidence of peripheral neuropathy. CONCLUSION: Eribulin, a novel synthetic antimicrotubule agent that binds to the vinca domain of tubulin and inhibits the polymerization of tubulin, offers a new treatment option for metastatic breast cancer or locally advanced breast cancer.

Eribulin mesylate (Halaven) for breast cancer.

Eribulin mesylate (Halaven-Eisai) has been approved by the FDA for treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapy regimens for metastatic cancer. Prior therapy should have included an anthracycline and a taxane in either an adjuvant or metastatic setting. Other drugs used to treat anthracycline- and taxane-refractory metastatic breast cancer include capecitabine (Xeloda), gemcitabine (Gemzar, and others) and vinorelbine (Navelbine, and others).

An in vitro assessment of wear particulate generated from NUBAC: a PEEK-on-PEEK articulating nucleus replacement device: methodology and results from a series of wear tests using different motion profiles, test frequencies, and environmental conditions.

STUDY DESIGN: In vitro biotribological wear particulate investigation. OBJECTIVE: To characterize poly-ether-ether-ketone (PEEK)-OPTIMA wear particulate generated from a series of wear tests used to evaluate the wear resistance and long-term biodurability of NUBAC, a PEEK-on-PEEK articulating nucleus replacement device, and compare with wear particulate associated with hip and knee total joint arthroplasties. SUMMARY OF BACKGROUND DATA: The use of PEEK in spinal arthroplasty represents a unique application of this material. Clinically, osteolysis, osteolytic changes, and adverse reactions to metal ions have been documented in spinal arthroplasty. Therefore, it is critically important to analyze the PEEK wear particulate to evaluate its resultant biologic reactivity. Historically, scanning electron microscopy (SEM) has been used for wear debris characterization. Light scattering, specifically laser diffraction, has also been successfully used. The combined use of both techniques may provide a more comprehensive analysis than either method alone. METHODS: Proteinacious serum containing PEEK wear debris generated from four groups of devices from separate wear tests underwent enzymatic and acid digestion. The particulate was analyzed using laser diffraction in duplicate, followed by SEM analysis. RESULTS: Laser diffraction analysis demonstrated a relatively large mean particle diameter on the basis of particle volume (16.5-40.0 µm) as compared with particle number (0.9-2.2 µm). For all groups, more than 50% of debris was larger than 5.0 µm. SEM analysis revealed a mean particle size consistent with the number-based laser diffraction results. The morphology of the wear particulate appeared to be similar for all the groups analyzed. CONCLUSION: The analysis of the particles generated from an articulating PEEK-on-PEEK nucleus replacement device shows debris within size ranges typical of other total joint arthroplasty implants, with relatively round morphology, along with the results suggesting a reduced particle load. These attributes tend to diminish the potential of these PEEK particles to elicit an inflammatory response.

Eribulin mesylate: a promising new antineoplastic agent for locally advanced or metastatic breast cancer.

More than one million women worldwide are diagnosed with breast cancer every year. For those diagnosed with metastatic breast cancer, the 5-year survival rates are low as, ultimately, patients develop tumors that become refractory to treatment. In clinical trials, eribulin mesylate (E7389) - a novel nontaxane microtubule dynamics inhibitor - demonstrated efficacy in patients with various solid tumors, in particular, those with heavily pretreated metastatic breast cancer. The Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389 (EMBRACE) study observed a significant increase in overall survival with eribulin compared with treatment of physician's choice (median: 13.1 vs 10.6 months, respectively). Based on these results, eribulin recently received approval by the US FDA for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapeutic regimens including an anthracyline and a taxane. In addition, eribulin has a manageable tolerability profile, requires no premedication and has shorter infusion times than most other microtubule-targeted agents.

An in vitro biotribological assessment of NUBAC, a polyetheretherketone-on-polyetheretherketone articulating nucleus replacement device: methodology and results from a series of wear tests using different motion profiles, test frequencies, and environmental conditions.

STUDY DESIGN: In vitro biotribological investigation. OBJECTIVE: To evaluate the wear resistance and long-term biodurability of NUBAC, a PEEK-on-PEEK articulating nucleus replacement device, using a series of wear tests with different motion profiles, test frequencies, and environmental conditions. SUMMARY OF BACKGROUND DATA: Wear resistance is critical for any disc arthroplasty device, and osteolysis remains a clinical concern. The use of PEEK for an articulating load bearing nucleus replacement device represents a unique application of this material. NUBAC has an inner ball/socket articulation for motion, similar to total disc replacements. American Society for Testing and Materials and International Organization for Standardization have recommended wear testing methodologies for total disc replacements, however, they have not been clinically validated. Therefore, a series of wear tests were performed to characterize the wear properties of the device. METHODS: Four groups of devices were evaluated. Group 1 consisted of +/-7.5 degrees flexion/extension to 10 million cycles (Mc) followed by +/-7.5 degrees lateral bending to 10 Mc, alternated to 40 Mc. Groups 2 to 4 consisted of International Organization for Standardization motion and load profiles to 10 Mc, except Group 3 incorporated frequency shifting to ensure a nonrepetitive load and motion profile. Group 4 underwent simulated aging. All studies incorporated a load magnitude of 225 to 1024 N. The average wear rates were determined using linear regression analysis with significant differences between groups determined (analysis of variance). RESULTS: A wear-in period was observed from 0 to 1 Mc. Wear rates were therefore calculated from 1 Mc. The wear rate for Group 1 was significantly less than Groups 2 to 4 through 10 Mc. From 1 to 5 Mc, the wear rate for Group 1 was significantly less than all groups, with Groups 2 to 4 not significantly different from each other. The wear rates for Groups 2 to 4 were seen to decrease after 5 Mc with only Group 3 significantly different than Group 1. The Group 1 wear rate was consistent throughout the test duration of 40 Mc. CONCLUSION: The experimental wear rates compare well with the reported wear rates of other material combinations used in nucleus replacement and total disc arthroplasty. Overall, wear rates were relatively low and consistent, suggesting long-term durability, a critical requirement of disc arthroplasty devices.

Tribological assessment of a flexible carbon-fibre-reinforced poly(ether-ether-ketone) acetabular cup articulating against an alumina femoral head.

New material combinations have been introduced as the bearing surfaces of hip prostheses in an attempt to prolong their life by overcoming the problems of failure due to wear-particle-induced osteolysis. This will hopefully reduce the need for revision surgery. The study detailed here used a hip simulator to assess the volumetric wear rates of large-diameter carbon-fibre-reinforced pitch-based poly(ether-ether-ketone) (CFR-PEEK) acetabular cups articulating against alumina femoral heads. The joints were tested for 25 x 10(6) cycles. Friction tests were also performed on these joints to determine the lubrication regime under which they operate. The average volumetric wear rate of the CFR-PEEK acetabular component of 54 mm diameter was 1.16 mm(3)/10(6) cycles, compared with 38.6 mm(3)/10(6) cycles for an ultra-high-molecular-weight polyethylene acetabular component of 28 mm diameter worn against a ceramic head. This extremely low wear rate was sustained over 25 x 10(6) cycles (the equivalent of up to approximately 25 years in vivo). The frictional studies showed that the joints worked under the mixed-boundary lubrication regime. The low wear produced by these joints showed that this novel joint couple offers low wear rates and therefore may be an alternative material choice for the reduction of osteolysis.