In an effort to provide a TKA bearing material that balances resistance to wear, mechanical failure and oxidation, manufacturers introduced antioxidant polyethylene. In many designs, this is accomplished through pre-blending the polymer with the antioxidant before consolidation and radiation crosslinking. This study reports the wear performance (in terms of thickness change) of a hindered phenol (PBHP) UHMWPE from analysis of an early series of knee retrievals and explores these questions: 1) What is early-time performance of this new bearing material? 2) Is there a difference in performance between fixed and mobile bearings in this design? 3) How does quantitative surface analysis help understand performance at the insert-tray modular interface? A series of 100 consecutive Attune™ knee inserts (DePuy Synthes, Warsaw, IN) received at revision by an IRB approved retrieval laboratory between September 2014 and March 2019 were investigated. In vivo duration was 0–52 months. Both the fixed bearing design (n=74) and the rotating platform mobile bearing design (n=26) were included. Dimensional change was determined by measurement of each insert and compared to the as-manufactured dimensions, provided by the manufacturer. The insert-tray interfaces under the loaded bearing zones were analyzed with light interferometry using an optical surface profiler (NewView™ 7300, Zygo, Middlefield, CT). Statistical analyses to explore relationships between measured variables were conducted using SPSS.Introduction
Methods
In vivo, UHMWPE bearing surfaces are subject to wear and oxidation that can lead to bearing fatigue or fracture. A prior study in our laboratory of early antioxidant (AO) polyethylene retrievals, compared to gamma-sterilized and highly cross-linked (HXL) retrievals, showed them to be more effective at preventing in vivo oxidation. The current analysis expands that early study, addressing the effect of:
manufacturing-variables on as-manufactured UHMWPE; in vivo time on these initial properties; identifying important factors in selecting UHMWPE for the hip or knee. After our prior report, our IRB-approved retrieval laboratory received an additional 96 consecutive AO-retrievals (19 hips, 77 knees: in vivo time 0–6.7 years) of three currently-marketed AO-polyethylenes. These retrievals represented two different antioxidants (Vitamin E and Covernox) and two different delivery methods: blending-prior-to and diffusing-after irradiation cross-linking. Consecutive HXL acetabular and tibial inserts, received at retrieval, with in vivo time of 0–6.7 years (260 remelted, 170 annealed) were used for comparison with AO-retrievals. All retrievals were analyzed for oxidation and trans-vinylene index (TVI) using a Thermo-Scientific iN10 FTIR microscope. Mechanical properties were evaluated for 35 tibial inserts by uniaxial tensile testing using an INSTRON load frame. Cross-link density (n=289) was measured using a previously published gravimetric gel swell technique. Oxidation was reported as maximum ketone oxidation index (KOI) measured for each bearing. TVI was reported as the average of all scans for each material. Cross-link density and mechanical properties were evaluated as a function of both TVI and oxidation.Introduction
Methods
Wear of polyethylene tibial inserts has been cited as being responsible for up to 25% of revision surgeries, imposing a very significant cost burden on the health care system and increasing patient risk. Accurate measurement of material loss from retrieved knee bearings presents difficult challenges because gravimetric methods are not useful with retrievals and unworn reference dimensions are often unavailable. Geometry and the local anatomy restrict in vivo radiographic wear analysis, and no large-scale analyses have illuminated long-term comparative wear rates and their dependence on design and patient factors. Our study of a large retrieval archive of knee inserts indicates that abrasive/adhesive wear of polyethylene inserts, both on the articular surface and on the backside of modular knees is an important contributor to wear, generation of debris and integrity of locking geometry. The objective of the current study is to quantify wear performance of tibial inserts in a large archive of retrieved knees of different designs. By assessing wear in a large and diverse series, the goal is to discern the effect on wear performance of a number of different factors: patient factors that might help guide treatment, knee design factors and bearing material factors that may inform a surgeon's choice from among the array of arthroplasty device options. An IRB approved retrieval database was queried for TKA designs implanted between 1997 and 2017. 1385 devices from 5 TKA designs were evaluated. Damage was ranked according to Hood's method, oxidation was determined through FTIR, and wear was determined through direct measurement of retrieved inserts using a previously established protocol. Design features (e.g. materials, conformity, locking mechanisms, stabilization, etc.) and patient demographics (e.g. age, weight, BMI, etc.) were cataloged. Multivariate analysis was performed to isolate factors contributing to wear, oxidation, and damage.Introduction
Methods
While advances in joint-replacement technology have made total ankle arthroplasty a viable treatment for end-stage arthritis, revision rates for ankle replacements are higher than in hip or knee replacements [1]. The questions asked in this study were (1) what retrieved ankle devices demonstrate about ankle arthroplasty failures, and (2) how do these failures compare to those seen in the hip and the knee? An IRB-approved retrieval laboratory received retrieved polyethylene inserts and surgeon-supplied reason for revision from 70 total-ankles (7 designs, including five currently-marketed designs) from 2002 to the present. All retrievals were rated for clinical damage. Polyethylene inserts received six months or less after retrieval (n=45) were analyzed for oxidation using Fourier Transform Infrared (FTIR) spectroscopy, reported as maximum ketone oxidation index [2]. Insert sterilization method was verified using trans-vinylene index [3]. Oxidation measured in the 45 ankle inserts versus their time in vivo was compared to oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6]. Statistical analysis was performed using IBM SPSS v.22.Introduction
Materials and Methods
The optimum UHMWPE orthopaedic implant bearing surface must balance wear, oxidation and fatigue resistance. Antioxidant polyethylene addresses free radicals, resulting from irradiation used in cross-linking, that could oxidize and potentially lead to fatigue damage under cycles of in vivo use. Assessing the effectiveness of antioxidant (AO) polyethylene compared to conventional gamma-sterilized or remelted highly cross-linked (HXL) polyethylene is necessary to set realistic expectations of the service lifetime of AO polyethylene in the knee. This study evaluates what short-term antioxidant UHMWPE retrievals can reveal about: (1) oxidation-resistance, and (2) fatigue-resistance of these new materials. An IRB-approved retrieval laboratory received 25 AO polyethylene tibial insert retrievals from three manufacturers with in vivo time of 0–3 years. These were compared with 20 conventional gamma-inert sterilized and 30 HXL (65-kGray, remelted) tibial inserts of the same in vivo duration range. The retrievals were (1) analyzed for oxidation and trans-vinylene index (TVI) using an FTIR microscope, and (2) inserts of sufficient size and thickness were evaluated for mechanical properties by uniaxial tensile testing using an INSTRON load frame. Oxidation was reported as maximum oxidation measured in the scan from the articular surface to the backside of each bearing. TVI was reported as the average of all scans for each material. Average ultimate tensile strength (UTS), ultimate elongation (UE), and toughness were the reported mechanical properties for each material.Introduction
Methods
Although patient-reported outcomes (PROs) have become increasingly important in the evaluation of spine surgery patients, interpretability may be limited by a patient's ability to recall pre-intervention impairment. The accuracy of patient recall of preoperative back pain, leg pain, and disability after spine surgery remains unknown. We sought to characterise the accuracy of patient recall of preoperative symptoms in a cohort of lumbar spine surgery patients. We analysed consecutive patients undergoing lumbar decompression or decompression and fusion for lumbar radiculopathy by a single surgeon over a four-year period. Using standardised questionnaires, we recorded back and leg numeric pain scores (NPS) and Oswestry Disability Indices (ODI) preoperatively and asked patients to recall their preoperative status at a minimum of one-year following surgery. We then statistically compared and characterised patient recall of their pre-operative status and their actual pre-operative status. Patients with incomplete follow up or diagnoses other than degenerative lumbar stenosis were excluded. Sixty-seven patients with a mean age of 66.1 years (55% female) were included in the final analysis. All cases were either posterior or combined anterior/ posterior procedures. Mean levels of surgery was 1.7 and 93.8% of all cases were instrumented. Mean duration of preoperative symptoms was 44.5 months (3.7 years). Preoperative vs postoperative PROs improved with regards to NPS back (5.2 vs 2.2, p= to 2 point difference), exceeding the minimal clinical important difference (MCID) for NPS. This pattern was maintained across age, gender, and duration of preoperative symptoms. We also observed cases of symptom minimisation recall bias, and cases in which back and leg pain predominance were switched in severity during recall bias. Significant recall bias of preoperative symptoms exists in patients undergoing spine surgery, potentially limiting accurate assessment and interpretation of PROs. An understanding of PROs and their limitations is essential to assess treatment efficacy of spinal procedures.
Irradiated, thermally stabilized, highly cross-linked UHMWPE bearings have demonstrated superior wear performance and improved in vitro oxidation resistance compared with terminally gamma-sterilized bearings, yet retrieval analysis reveals unanticipated in vivo oxidation in these materials. There has been little evidence to date that oxidation in these materials is leading to degradation of mechanical properties, but since oxidation has previously been shown to cause chain scission in other materials, there is the potential for oxidation to cause decreased molecular weight and crosslink density. The aim of this study was to determine whether measured in vivo oxidation in highly cross-linked tibial bearings corresponds with a decreasing crosslink density. Retrieval analysis for three tibial bearing materials reveals that crosslink density is decreasing following in vivo duration, and that the change in crosslink density is strongly correlated with oxidation. The results suggest that oxidation in highly cross-linked materials is causing chain scissions that may impact the material properties. If the correlation between oxidation and duration continues, then as longer duration, more oxidized devices are retrieved there is a potential for measurable mechanical property changes.
