Background

Additive manufacturing (AM) has created many new avenues for material and manufacturing innovation. In orthopaedics, metal additive manufacturing is now widely used for production of joint replacements, spinal fusion devices, and cranial maxillofacial reconstruction. Plastic additive manufacturing on the other hand, has mostly been utilized for pre-surgical planning models and surgical cutting guides. The addition of pharmaceuticals to additively manufactured plastics is novel, particularly when done at the raw material level. The purpose of this study was to prove the concept of antibiotic elution from additively manufactured polymeric articles and demonstrate feasibility of application in orthopaedics.

The wear particles released from the polyethylene (PE) tibial insert of modular total knee replacements (TKRs) have been shown to cause wear particle induced osteolysis, which may necessitate revision surgery [1]. Wear occurs at the backside surface of the PE insert of modular TKRs, resulting from the relative movement between the PE insert and the tibial tray [2]. Wear particles generated from the backside surface of the PE insert have been shown to be smaller in size than those originating from the articular surface [1], and may therefore have increased biological activity and osteolytic potential [3-4]. The ability to predict backside micromotion and contact pressure by finite element simulation has previously been demonstrated by O'Brien et al. [6-7]. Although the effect of insert thickness on articular surface contact pressure has been investigated [5], the effects of insert thickness on backside contact pressures, backside micromotion, and wear has not received adequate attention. Brandt et al. [2] has suggested that increased insert thickness was associated with increased backside damage (Fig. 1). In the present study, finite element simulations were conducted using the Sigma - Press Fit Condylar TKR (Sigma-PFC®, DePuy Orthopedics Inc., Warsaw, IN) with inserts of different insert thickness ranging between 5, 10, 15, 20 and 25 mm. The TKRs were simulated under ISO 14343-2 [8]. A non-linear PE material model was implemented by means of the J2-plasticity theory [6] and the effects of insert thickness on backside micromotion and contact pressure were analyzed. At the peak loading of the simulated gait cycle (time=13%), the 5 mm thick PE insert showed a greater backside peak contact pressure than the 25 mm thickness PE insert. Increasing insert thickness from 5 mm to 25 mm lead to approximately 15% greater peak micromotion at the modular interface (Fig. 2). This effect may be attributed to the ability of the PE material to distribute the load more evenly through deformation at the modular interface and reduce micromotion for thinner inserts. It is suggested that increased insert thickness results in increased moments at the modular interface that could lead to increased backside wear in silico. Although an increase in PE insert thickness was only associated with a moderate increase in backside micromotion in the present study, it was deemed likely that backside micromotion could be accelerated for thicker inserts in vivo as the PE locking mechanism has been shown to degrade after extended implantation periods.

Purpose

Current practice requires all post-operative hip and knee arthroplasty patients complete a series of clinical questionnaires at each visit. The patients responses to these questionnaires are used as a clinical evaluation tool for the surgeons to assess functionality, satisfaction and pain at routine pre and post-operative visits. The recent installation of 4 touch screen computer terminals, located in the patient waiting area, has created the opportunity to have the patients complete these questionnaires by using only the touch screen entry system. This eliminates the need for clinic staff to manually enter the patients responses into the clinics database, eliminate potential data entry errors, and will significantly reduce the amount of time and paper required to prepare questionnaires for each patient. In addition to possibly increasing the volume of data we can collect in our clinic, this also allows the surgeon to have immediate access to the patients responses which can be reviewed prior to seeing the patient in the office. Our goal was to determine the overall level of patient satisfaction with using the new touch screen direct entry system, the efficiency of completion and the quality of data entry occurring from the direct entry system.

Wear of the polyethylene (PE) insert in total knee replacements can lead to wear-particle and fluid-pressure induced osteolysis. One major factor affecting the wear behaviour of the PE insert in-vivo is the surface characteristics of the articulating femoral components. Contemporary femoral components available in Canada are either made of cast Cobalt Chromium (CoCr) alloy or have an oxidized zirconium surface (Oxinium). The latter type of femoral components have shown to have increased abrasive wear resistance and increased surface wettability, thus leading to reduced PE wear in-vitro compared with conventional cast CoCr components. Although surface damage has been reported on femoral components in general, there have been no reports in the literature as to what extent the recommended operating techniques affect the surface tribology of either type of femoral component.

Twenty-two retrieved total knee replacements were identified with profound surface damage on the posterior aspect of the femoral condyles. The femoral components were of three different knee systems: five retrievals from the NexGen(r) total knee system (Zimmer Inc., Warsaw, IN), twelve retrievals from the Genesis II(r) total knee system (CoCr alloy or Oxinium; Smith & Nephew Inc., Memphis, TN), and five retrievals from the Duracon(r) total knee system (Stryker Inc., Mahwah, NJ). Reasons for revision were all non-wear-related and included aseptic loosening in two cases, painful flexion instability, and chronic infection. All retrieved femoral components showed evidence of surface damage on the condyles, at an average of 99° flexion (range, 43° – 135° flexion). Titanium (Ti) alloy transfer and abrasive surface damage were evident on all retrieved CoCr alloy femoral components that came in contact with Ti alloy tibial trays. Surface damage on the retrieved Oxinium femoral components was gouging, associated with the removal and cracking of the oxide and exposure of the zirconium alloy substrate material. CoCr alloy femoral components that had unintended contact with CoCr alloy tibial trays also showed evidence of gouging and abrasive wear.

All femoral components showed severe surface damage in the posterior aspect of the condyles. The femoral surface was heavily scratched and the oxidized zirconium coating surface appeared removed. The surface analysis suggested that the surface damage most likely occurred during the time of initial implantation. In particular, it appeared that the femoral condyles were resting on the posterior aspect of the tibial tray in flexion, thus scratching the femoral components. Such scratches could potentially lead to accelerated PE insert wear and reduced implant longevity, thus making expensive revisions surgery necessary. The authors strongly suggest a revision of the current operating techniques recommended by the implant manufacturer to prevent this type of surface damage from occurring.

Introduction

Radiostereometric Analysis (RSA) is an imaging method that is increasingly being utilized for monitoring fixation of orthopaedic implants in randomized clinical trials. Extensive RSA research has been conducted over the last 35+ years using standard clinical x-ray acquisition modalities that irradiate screen/film media or Computed Radiography (CR) plates. The precision of RSA can depend on a number of factors including modality image quality.

Purpose: The purpose of this study is to measure in vivo linear head penetration of a newer generation highly crosslinked liner (X3, Stryker Orthopedics) using Radiostereometric Analysis (RSA).

Method: The 12 hips (11 patients) included in this study are a subset from a larger randomized controlled trial comparing Exeter stem migration in cement mantles with and without Tobramycin. Criteria for inclusion in this subset were the use of an uncemented Trident acetabular component containing X3 polyethylene in combination with a 32 mm stainless steel femoral head. The average age was 72.7 years (range 65 to 80), and there was an equal gender distribution. RSA examinations were taken with patients lying supine at six weeks, six months, one year, and two years postoperatively. The six week examinations were used as the reference examinations for measuring head penetration. Radiographic measurements and analyses were performed with the UmRSA software suite version 6.0 (RSA Biomedical, Umea, Sweden). Head penetration was determined via edge-detection measurements of the femoral head and acetabular cup.

Results: The mean cumulative femoral head penetration at 6 months was 0.23 mm; this remained statistically unchanged both at 1 year: 0.20mm (p=0.69, 95% UCL of the difference: +0.15mm) and 2 years: 0.25mm (p=0.77, 95% UCL of the difference: +0.10mm).

Conclusion: It is generally recognized that femoral head penetration of more than 0.1 mm per year can result in osteolysis. The purpose of cross linking polyethylene is to reduce wear to below this level. The results of this study show that after an initial bedding in of approximately 0.2 mm, femoral head penetration is not detectable over the subsequent 18 months. Further follow-up is underway to confirm that this promising reduction in wear is maintained.

Purpose: The purpose of this study is to determine if the addition of Tobramycin antibiotic powder to cement for primary hip replacement surgery increases the risk of long term aseptic loosening. This was accomplished by measurement of implant micromotion with Radiostereometric Analysis (RSA).

Method: Exeter femoral stems and Trident acetabular components were implanted into 33 patients. Stems were cemented in a randomized manner with either Simplex P or Simplex T. Tantalum beads were injected into the femur to serve as reference points for RSA measurements. RSA examinations were taken with supine positioning at six weeks, six months, one year, and two years post-operatively. Radiographic measurements and analyses were performed with the UmRSA software suite version 6.0 (RSA Biomedical, Umea, Sweden). Distal migration of the stem centroid was measured at each follow-up period and the mean migration rates for both groups were determined. Non-inferiority testing of stem migration in Simplex T compared to Simplex P was accomplished using a one sided t-test, with the significance level set at 0.05. A clinically inferior additional amount of distal migration was set at 0.4mm/yr.

Results: Eleven patients were excluded from the study: seven patients either dropped out of the study or missed the six week and/or two year follow-up examinations, two patients had radiographic image quality issues, and two patients had loosening of their tantalum markers in subsequent follow-ups. Of the remaining 22 patients, eight were male and 14 were female, with an average age at time of surgery of 71.2 (range, 63–81) years. The mean total distal migrations for the Tobramycin and non-Tobramycin cement groups at two years were 0.891 and 0.732 mm, respectively; the mean stem migration rates were 0.263 and 0.179 mm/yr, respectively. The differences in total distal migration and stem migration rate were not statistically significant (P = 0.06 and UCL = 0.173, respectively).

Conclusion: The addition of Tobramycin to Simplex cement does not appear to impact the distal migration pattern for a polished tapered cemented hip stem at two years. This finding suggests that Tobramycin does not have any clinically relevant deleterious effects on the in vivo mechanical properties of Simplex cement.