Introduction

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?

Introduction

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;

Introduction

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.

Introduction

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?

Introduction

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.

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.

A common feature of retrieved ceramic-on-ceramic (CoC) hips is the presence of metal transfer on the femoral head. This metal transfer represents an important change in the articulating surface and can have consequences in terms of lubrication, friction, wear, and squeaking. Given the potential impact of metal transfer on the performance of CoC bearing couples, a good understanding of the factors surrounding its occurrence is warranted. This study documents the metal transfer onto a ceramic femoral head with two subluxations onto the rim of the cup which occurred during surgery. This metal transfer is compared to that on other ceramic heads retrieved for various reported reasons, including squeaking, pain and loosening.

The first ten retrieved alumina heads of current ceramic technology (Ceramtec, Plochingen, Germany) submitted to our retrieval laboratory were assessed to document the phenomenon of metal transfer. Nine devices underwent in vivo service (mean duration 32 mo., range 13 to 84) and the tenth device was removed intra-operatively and serves as an instructive control case. It was impacted onto a trunnion and during final testing for stability subluxed anteriorly over the titanium lip of the cup. The metal transfer was immediately noted by the surgeon and the head was removed.

All ceramic heads were examined under light microscopy (Nikon Dissecting Microscope, Tokyo, Japan) and white light optical profilometry (NewView 7300, Zygo, Middlefield, CT).

The control ceramic head showed two distinct metal transfer streaks from two discrete subluxation events that were documented by the surgeon (IMT). Those streaks are aligned in a direction approximately 24o to the right (clockwise) of a line through the polar apex of the head and parallel to the axis of the femoral neck. Microscopy and profilometry indicate that they were laid down in a direction from equator-toward-pole.

Seven of the retrieved ceramic heads showed streaks of metal transfer that are very similar to those on the control ceramic head in terms of: alignment (equator-toward-pole, 20 to 45o off-axis) width (tapered point growing to approximately 1.0 to 1.5 mm), depth of metal deposition (0.25 to 0.40 μm), and depositional texture.

It is notable that the metal transfer streaks commonly observed on retrievals bear a close resemblance to that caused by a single intra-operative event wherein a hip abduction force pulled the head into contact with the titanium cup/liner rim. An important implication is that this demonstrates that metal transfer can occur with a single instance of rim contact, wherein the femoral head is forced against the metal cup rim. If metal transfer onto the head were to occur during final reduction of the hip, its presence may well be undetected and any deleterious in vivo impact of the metal transfer would be in effect from the day of surgery.

Squeaking of ceramic-on-ceramic (CoC) hips is a clinical phenomenon that is concerning with regard to the long term performance of these joint devices. Investigations into the cause of the squeaking have focused on patient factors and demographics, surgical placement, and other non-ceramic components in the devices. The current study tests latest-generation CoC devices to measure the vibration modes and frequencies of the components individually as well as assembled in the complete surgical construct.

Audio data from clinical cases of squeaking hips were analysed to determine the frequencies present. Retrieved CoC hips (n = 7) and never-implanted CoC bearing couples (n = 3) were tested in the laboratory for squeaking under loaded articulation.

Bovine serum was introduced into the CoC articulation and dried to promote stick-slip motion at the articulation. Squeaking sounds from the in vitro tests were recorded for audio analysis. Low mass, high frequency-response ceramic shear piezoelectric accelerometers (PCB Piezotronics) were adhered to the hip components along multiple axes to measure vibrations during testing.

Clinical audio shows that squeaking occurs at fundamental frequencies in the range of 1 to 3 kHz, with harmonics above the fundamental frequency. Retrieved CoC bearing couples squeaked at fundamental frequencies from 1.5 kHz to 3.8 kHz. Fourier Transform analysis of the audio closely matched the concurrent output from the accelerometers mounted directly on the ceramic components. This held true even in the absence of metal components in the system. With metal components included in the test construct (acetabular shell, acetabular cup, femoral stem), those components also vibrated at the same frequencies as the ceramic bearing couples, indicating that the CoC articulation is the source of the vibrations, with metal components conducting and emanating the sound.

The never-implanted bearing couples were made to squeak and vibrated at fundamental frequencies ranging from 1 kHz to 8 kHz.

Squeaking from CoC hips can be reproduced in the lab using components from clinical retrievals. Instrumentation of the explanted hips confirms that the vibration frequencies of the ceramic components themselves match the audible squeaking. The squeaking of ceramic components mounted with soft polymers and with no metal contact at any point indicates that the ceramic components themselves are the source of the clinical squeaking. The measured vibration of ceramic components in the audible range is an observation not predicted by modeling studies reported in the literature to date.

Irradiation cross-linking of UHMWPE has been shown to reduce wear while generating free radicals that oxidise in the presence of oxygen or oxidising species. Various methods have been used to minimise or eliminate the effect of these free radicals including below-melt annealing, remelting, Vitamin E infusion, or the use of other antioxidants. Each method has benefits and drawbacks with respect to wear properties, mechanical properties, and chemical properties. Accelerated aging techniques are used to evaluate the efficacy of new methods in stabilising free radicals in highly cross-linked UHMWPE.

Various procedures have been described for aging standard gamma-air sterilised UHMWPE to produce oxidation levels that represent shelf-aged bearings. An important factor in evaluating and comparing these aging techniques is validating that they reproduce the profile of oxidation (depth and magnitude) seen both in gamma-air, shelfaged polyethylene and in clinical retrievals. Moreover, the resulting oxidation level in the aged UHMWPE should predict the fatigue and/or wear damage seen in retrieved gamma-air inserts and liners.

The present study compared clinically relevant UHMWPE samples aged with ASTM 2003-00, (Method B: 70°C, 5 atm O2, 14 days) and a published lower temperature, lower oxygen-pressure environment (63° C, 3 atm O2, 28 days). Longer aging times (35 to 42 days) were also tested to examine oxidation rate and time to onset of mechanical degradation.

Both published methods result in oxidation of gamma-air and gamma-barrier sterilised polyethylene, but have little effect on remelted or antioxidant stabilised crosslinked polyethylene. These aging protocols, however, did not bring standard polyethylene to the critical oxidation level necessary for the fatigue damage that is seen in retrieved inserts and liners.

Oxidation of gamma-air and gamma-barrier sterilised UHMWPE increases exponentially with time on the shelf or in the two aging environments. Of note, longer aging times (35 to 42 days) that bring standard UHMWPE to sufficiently high oxidation levels for fatigue to occur also cause increased oxidation levels in remelted UHMWPE.

Oxidation increases were the smallest in antioxidant UHMWPE, though still detectable.

While this oxidation is not high enough in remelted material or antioxidant material to cause the fatigue damage seen in gamma-air sterilised UHMWPE, it does raise concerns about the published aging techniques and the long term stability of the new materials in vivo.

Relying on artificial aging techniques that do not adequately challenge even gamma-air polyethylene may conceal unforeseen weaknesses of new materials. Using longer aging times for existing techniques or novel aging approaches may be necessary to effectively evaluate the long term stability of new bearing materials.

The purpose of this study is the biomechanical comparison of five C1 – C2 posterior arthrodesis techniques. Ten adult human cadaveric upper cervical spine specimens were sectioned at the C3 level. The occiput and C3 vertebra were potted in PMMA. The specimens were tested intact; after destabilizing with odontoid transection and sectioning of the transverse and capsular ligaments; and after stabilization with Brooks-Jenkins cable fixation, Brooks-Jenkins with unilateral transarticular screw, Gallie posterior wire construct with unilateral transarticular screw, Brooks-Jenkins with bilateral screws, and Gallie with bilateral screws. Data were analysed with special attention paid to the motion at C1 – C2. The neutral zone (NZ) and range of motion (ROM) were measured in the main plane of each motion, as well as in coupled planes. In flexion / extension and lateral bending, the ROM and NZ increased significantly in the injured specimens as compared to the intact (p< 0.0001).

In axial torsion, there was no significant difference between the intact and injured spines at C1 – C2 level. In the different fixation systems, the ROM and NZ were significantly lower than in injured and intact spines in all motions (p< 0.01), except the lateral bending in intact spine. Among the 5 instrumentations, the NZ and ROM in flexion / extension for the Gallie construct with one screw were significantly higher than for the Brooks-Jenkins construct with one or two screws (p< 0.05). In axial torsion, the Gallie construct with one screw displayed a larger NZ and ROM than any of the other four constructs (p< 0.05).