A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
This study used model-based radiostereometric analysis (MBRSA) to compare migration of a recently introduced cementless hip stem to an established hip stem of similar design. Novel design features of the newer hip stem included a greater thickness of hydroxyapatite coating and a blended compaction extraction femoral broach. Fifty-seven patients requiring primary total hip arthroplasty (THA) were enrolled at a single centre. Patients were randomized to receive either an Avenir collarless stem and Trilogy IT cup (ZimmerBiomet) or a Corail collarless stem and Pinnacle cup (DePuy Synthes) via a posterior or lateral approach. Both stems are broach-only femoral bone preparation. RSA beads (Halifax Biomedical) were inserted into the proximal femur during surgery. Patients underwent supine RSA imaging a 6 weeks (baseline), 6, 12, and 24 months following surgery. The primary study outcome was total subsidence of the hip stem from baseline to 24 months as well as progression of subsidence between 12 and 24 months. These values were compared against published migration thresholds for well-performing hip stems (0.5mm). The detection limit, or precision, of MBRSA was calculated based on duplicate examinations taken at baseline. Patient reported outcome measures were collected throughout the study and included the Oxford-12 Hip Score (OHS), EuroQoL EQ-5D-5L, Hip Osteoarthritis Score (HOOS) as well as visual analogue scales (VAS) for thigh pain and satisfaction. Analysis comprised of paired and unpaired t-tests with significance set at p≤0.05. Forty-eight patients (30 males) were included for analysis; 7 patients received a non-study hip stem intra-operatively, 1 patient suffered a traumatic dislocation within three weeks of surgery, and 1 patient died within 12 months post-surgery. RSA data was obtained for 45 patients as three patients did not receive RSA beads intra-operatively. Our patient cohort had a mean age of 65.9 years (±;7.2) at the time of surgery and body mass index of 30.5 kg/m2 (±;5.2). No statistical difference in total stem migration was found between the Avenir and Corail stems at 12 months (p=0.045, 95%CI: −0.046 to 0.088) and 24 months (p=0.936, 95% CI: −0.098 to 0.090). Progression of subsidence from 12-24 months was 0.011mm and 0.034mm for the Avenir and Corail groups which were not statistically different (p=0.163, 95%CI: −0.100 to 0.008) between groups and significantly less than the 0.5mm threshold (pNo statistically significant differences existed between study groups for any pre-operative function scores (p>0.05). All patients showed significant functional improvement from pre- to post-surgery and no outcome measures were different between study groups with exception of EQ-5D-5L health visual analogue scale at 12 months which showed marginally superior (p=0.036) scores in the Avenir group. This study was not powered to detect differences in clinical outcomes. This study has demonstrated no statistical difference in subsidence or patient-reported outcomes between the Corail hip stem and the more recently introduced Avenir hip stem. This result is predictable as both stems are of a triple-tapered design, are coated with hydroxyapatite, and utilize a broach-only bone preparation technique. Both stem designs demonstrate migration below 0.5mm suggesting both are low-risk for aseptic loosening in the long-term.
Total hip arthroplasty (THA) is one of the most successful and commonly performed surgical interventions worldwide. Based on registry data, at one-year post THA, implant survivorship is nearly 100% and patient satisfaction is 90%. A novel, porous coated acetabular implant was introduced in Europe and Australia in 2007. Several years after its introduction, warnings were issued for the system when used with metal-on-metal bearings due to adverse local tissue reaction, with one study reporting a 24% failure rate (Dramis et al. 2014). A subsequent 2018 study by Teoh et al. showed that the acetabular system had a survival rate of 98.9% at five years when used with conventional polyethylene or ceramic bearing surfaces. The current study was conducted to determine the safety and effectiveness of the acetabular system using standard highly-crosslinked polyethylene (XLPE) and ceramic liners at five-year follow-up. Our hypothesis was that the acetabular system would exhibit survivorship comparable to other acetabular components on the market at five-year follow-up. A prospective, non-randomized study was conducted from February 2009 to June 2017 at eight sites in Canada and the USA. One hundred fifty-five hips were enrolled and 148 hips analyzed after THA indicated for degenerative arthritis. At five-year follow-up, 103 subjects remained for final analysis. All patients received a zero, three, or multi-hole R3 acetabular shell with Stiktite porous coating (Smith & Nephew, Inc., Memphis, TN, USA). Standard THA surgical techniques were employed, with surgical approach and either of a XLPE or ceramic bearing surface chosen at the discretion of the surgeon. The primary outcome was revision at five-years post-op with secondary outcomes including the Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), radiographic analysis, and post-operative adverse events. Data and outcomes were analyzed using summary statistics with 95% confidence intervals, t-tests, and Wilcoxon Rank tests. At five-year follow-up the overall success rate was 97.14% (95% CI: 91.88–100). When analyzed by liner type, the success rate was 96.81% (95% CI: 90.96–99.34) for polyethylene (n=94) and 100% (95% CI: 71.51–100) for ceramic (n=11), with no significant difference between either liner type (p=1). There were three revisions during the study (1.9%), two for femoral stem revision post fracture, and one for deep infection. The HHS (51.36 pre-op, 94.50 five-year), all 5 HOOS sub-scales, and WOMAC (40.9 pre-op, 89.13 five-year) scores all significantly improved (p < 0 .001) over baseline scores at all follow-up points. One (0.7%) subject met the criteria for radiographic failure at one-year post-op but did not require revision. Six (1.8%) of the reported adverse events were considered related to the study device, including four cases of squeaking, one bursitis, and one femur fracture. Results from this five-year, multicenter, prospective study indicate good survivorship for this novel, porous coated acetabular system. The overall survivorship of 97.14% at five-year follow-up is comparable to that reported for similar acetabular components and aligns with previous analyses (Teoh et al. 2018).
The purpose of this study was to examine the influence of weight-bearing on the measurement of in vivo wear of total knee replacements using model-based RSA at 1 and 2 years following surgery. Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained. In order to assess in vivo wear, a highly accurate 3-dimensional virtual model of each in vivo TKA was developed. Coordinate data from RSA radiographs (mbRSA v3.41, RSACore) were applied to digital implant models to reconstruct each patient's replaced knee joint in a virtual environment (Geomagic Studio, 3D Systems). Wear was assessed volumetrically (digital model overlap) on medial and lateral condyles separately, across each follow-up. Annual rate of wear was calculated for each patient as the slope of the linear best fit between wear and time-point. The influence of weight-bearing was assessed as the difference in annual wear rate between standing and supine exams. Age, BMI, and Oxford-12 knee improvement were measured against wear rates to determine correlations. Weight bearing wear measurement was most consistent and prevalent in the medial condyle with 35% negative wear rates for the lateral condyle. For the medial condyle, standing exams revealed higher mean wear rates at 1 and 2 years, supine, 16.3 mm3/yr (SD: 27.8) and 11.2 mm3/yr (SD: 18.5) versus standing, 51.3 mm3/yr (SD: 55.9) and 32.7 mm3/yr (SD: 31.7). The addition of weight-bearing increased the measured volume of wear for 78% of patients at 1 year (Avg: 32.4 mm3/yr) and 71% of patients at 2 years (Avg: 48.9 mm3/yr). There were no significant (95% CI) correlations between patient demographics and wear rates. Volumetric, weight-bearing wear measurement of TKR using model-based RSA determined an average of 33 mm3/yr at 2 years post-surgery for a modern, non-cross-linked polyethylene bearing. This value is comparable to wear rates obtained from retrieved TKRs. Weight-bearing exams produced better wear data with fewer negative wear rates and reduced variance. Limitations of this study include: supine patient imaging performed at post-op, no knee flexion performed, unknown patient activity level, and inability to distinguish wear from plastic creep or deformation under load. Strengths of this study include: large sample size of a single TKR system, linear regression of wear measurements and no requirement for implanted RSA beads with this method. Based on these results, in vivo volumetric wear of total knee replacement polyethylene can be reliably measured using model-based RSA and weight-bearing examinations in the short- to mid–term. Further work is needed to validate the accuracy of the measurements in vivo.
The purpose of this research was to determine the feasibility of radiostereometric analysis (RSA) as a diagnostic tool for assessing non-union following spinal arthrodesis procedures. Further, to estimate clinical thresholds for precision and accuracy of the proposed method in the cervical and lumbar spine. A three-level lumbo-sacral and a four-level cervical posterior arthrodesis procedures were performed on an artificial spine model (Sawbones, WA). Using a spring loaded inserter (RSA Biomedical, Sweden), eight to ten RSA markers were placed within each of the L4 and L5 segments in the spinous process (L4 only), lamina, transverse processes, posterior and anterior (down the pedicle) wall of the vertebral body. Eight to ten markers were placed within the proximal sacrum (S1) at the medial and lateral crests, tuberosity, and within the sacral canal wall. Four to eight RSA markers were placed into the C3-C6 lateral masses. Titanium screws and rods were applied to the spinal segments. Identical procedures were then performed on a cadaveric spine using similar bead placement and hardware. RSA imaging consisted of 12 double exams (24 exams) of the cervical and lumbar regions for both the Sawbones and cadaveric spine to assess precision of measurement under zero-displacement conditions. The most distal vertebrae were considered the datum against which the movement of all other vertebrae was compared. The artificial spine was then dismantled for accuracy assessment in which the middle vertebrae (L5 and C4-C5) were moved relative to the superior (L4 and C3) and inferior (S1 and C6) vertebrae by known, incremental displacements on an imaging phantom device. Displacements occurred along the superior-inferior, anterior-posterior, and flexion-extension (rotational) axes of motion. RSA images were obtained at each displacement. Image analysis was performed using model-based software (RSACore v3.41, Leiden, Netherlands) to visualize implanted RSA beads in 3-D space. Precision was defined as the 95% confidence interval of error in measuring zero-displacement. Accuracy was defined as the mean difference (with 95% confidence interval) between the known and measured displacement. The rate of RSA bead detection was high with 5–8 implanted beads being visible in both the lumbar and cervical regions of the artificial and cadaveric spines. Translational RSA precision for both spines was better than 0.25 mm and 0.82 mm for the lumbar and cervical regions, respectively. Rotational precision was better than 0.40° and 1.9° for the lumbar and cervical regions, respectively. RSA accuracy for the artificial spine overall demonstrated less than 0.11 mm translational bias (margin < ±0.02 mm) and less than 0.22° rotational bias (margin < ±0.15°). This study demonstrates that RSA achieves sufficient precision and accuracy to detect intervertebral micromotion for the purpose of assessing arthrodesis. Well dispersed RSA bead placement is critical to achieving sufficient accuracy as well as avoiding occlusion by metal hardware. Cervical bead implantation is particularly sensitive to bead clustering due to small vertebrae size and proximity to critical structures. The results of this work will aid in the development of a clinical study to assess arthrodesis in patients.
Total hip arthroplasty (THA) is a highly successful procedure achieving excellent clinical outcomes beyond 10 years post-surgery. With exception of periprosthetic infection, dislocation is the most common cause of failure in THA. A novel reverse total hip (RTH) replacement has been developed to address dislocation through reversal of the typical THA articulation in which a femoral cup and acetabular ball interlock at the extremes of motion to enhance mechanical stability in all planes. The purpose of this study was to assess the safety and efficacy of this novel RTH in a series of 22 patients and to monitor implant fixation using radiostereometric analysis (RSA). Twenty two patients with end-stage osteoarthritis of the hip were enrolled between 2017 and 2019 at a single center. All surgeries were performed by a group of four high-volume fellowship-trained arthroplasty surgeons. All patients received at least 1 acetabular cup screw and RSA markers inserted into the acetabulum and proximal femur. Follow-up time points were 6 weeks, 6, 12 and 24 months and included patient reported outcome measures (HOOS, Oxford-12, Harris Hip Score, SF-36 and Satisfaction) as well as RSA assessment.Introduction
Methods
The anatomy of the human knee is very different than the tibiofemoral surface geometry of most modern total knee replacements (TKRs). Many TKRs are designed with simplified articulating surfaces that are mediolaterally symmetrical, resulting in non-natural patterns of motion of the knee joint [1]. Recent orthopaedic trends portray a shift away from basic tibiofemoral geometry towards designs which better replicate natural knee kinematics by adding constraint to the medial condyle and decreasing constraint on the lateral condyle [2]. A recent design concept has paired this theory with the concept of guided kinematic motion throughout the flexion range [3]. The purpose of this study was to validate the kinematic pattern of motion of the surface-guided knee concept through in vitro, mechanical testing. Prototypes of the surface-guided knee implant were manufactured using cobalt chromium alloy (femoral component) and ultra-high molecular weight polyethylene (tibial component). The prototypes were installed in a force-controlled knee wear simulator (AMTI, Watertown, MA) to assess kinematic behavior of the tibiofemoral articulation (Figure 1). Axial joint load and knee flexion experienced during lunging and squatting exercises were extracted from literature and used as the primary inputs for the test. Anteroposterior and internal-external rotation of the implant components were left unconstrained so as to be passively driven by the tibiofemoral surface geometry. One hundred cycles of each exercise were performed on the simulator at 0.33 Hz using diluted bovine calf serum as the articular surface lubricant. Component motion and reaction force outputs were collected from the knee simulator and compared against the kinematic targets of the design in order to validate the surface-guided knee concept.Background
Methods
This research determines the feasibility of radiostereometric analysis (RSA) as a diagnostic tool for assessing fusion following spinal arthrodesis. Further, to estimate clinical thresholds for precision and accuracy of the proposed method in the cervical and lumbar spine. Two-level lumbo-sacral and three-level cervical posterior arthrodesis procedures were performed on an artificial spine model and a cadaveric spine (Figure 1). Using a spring-loaded inserter, RSA marker beads were placed within each of the L4-S1 and C3-C6 vertebrae, then analyzed for optimal bead distribution and detection. RSA imaging consisted of 12 double exams (24 exams) of the cervical and lumbar regions for both the Sawbones and cadaveric spine to assess precision of measurement under zero-displacement conditions, defined as the 95% confidence interval of error. Accuracy assessment was performed on the Sawbones model in which the middle vertebrae (L5 and C4-C5) were moved relative to the superior (L4 and C3) and inferior (S1 and C6) vertebrae by known, incremental displacements (Figure 2). RSA images were obtained at each displacement (Figure 3). Accuracy was defined as the mean difference between known and measured displacements.Introduction
Methods
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. Using patented processes, three heat-stable antibiotics commonly used in orthopaedics were combined with six biocompatible polymers (2 bioresorbable) into filament and powder base materials for fused deposition modeling (FDM) and selective laser sintering (SLS) AM processes. Raw materials of 1%, 2%, and 5% antibiotic concentrations (by mass) were produced as well as a blend of all three antibiotics each at 1% concentration. Thin disks of 25 mm diameter were manufactured of each polymer with each antibiotic at all concentrations. Disks were applied to the center of circular petri dishes inoculated with a bacterium as per a standard zone of inhibition, or Kirby-Bauer disk diffusion tests. After 72 hours incubation, the zone of inhibited bacterial growth was measured. Periprosthetic joint infection (PJI) of the knee was selected as the proof-of-concept application in orthopaedics. A series of tibial inserts mimicking those of a common TKR system were manufactured via SLS using a bioresorbable base material (Figure 1). Three prototype inserts were tested on a knee wear simulator for 333,000 cycles following ISO 14242–1:2014 to approximate 2–4 months of Background
Methods
The purpose of this study was to examine the influence of weight-bearing on the measurement of Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained. In order to assess Purpose
Methods
A retrospective study was conducted to measure short-term Nonweightbearing supine RSA exams were performed postoperatively and at six, 12, and 24 months. Weightbearing standing RSA exams were performed on select patients at 12 and 24 months. Wear was measured both linearly (joint space) and volumetrically (digital model overlap) at each available follow-up. Precision of both methods was assessed by comparing double RSA exams. Patient age, sex, body mass index, and Oxford Knee Scores were analyzed for any association with PE wear.Aims
Patients and Methods
Detailed analysis of retrieved total hip replacements (THRs) is valuable for assessing implant and material successes and failures. Reduction of bearing wear and corrosion and fretting of the head-neck trunnion is essential to implant durability and patient health. This research quantifies and characterizes taper and bearing surface damage on retrieved oxidized zirconium THRs. Initially, 11 retrieved oxidized zirconium femoral heads were examined along with their associated femoral stems. Relevant patient and retrieval data was collected from clinical charts and radiographs. Taper corrosion (Figure 1) and fretting damage (Figure 2) scoring was performed following the Dyrkacz [1] method. A coordinate measuring machine was used to obtain a detailed surface map of the male and female taper surfaces. Taper surface maps were best-fit with an idealized cone followed by volume subtraction to quantify the amount of material removed as a result of fretting and corrosion processes. Scanning electron microscopy was performed on select samples to identify specific damage modes. Unique surface bumps were noted on the articular surface of select femoral heads (Figure 3). Seventeen femoral heads were added to the analysis specifically for identification of these bumps. Articular surfaces were searched under SEM magnification and bumps were identified and counted. Parametric statistical correlations were performed with SAS v9.3.Introduction
Methods
Non-large head Metal-on-metal (MoM) hip replacements were seen as a solution to concerns about implant wear in younger patients. Mid-term loosening of once well-fixed hydroxyapatite (HA) coated femoral stems was recently observed in select MoM patients upon revision surgery. Accordingly, an implant retrieval study was undertaken to examine the incidence of aseptic loosening of in HA-coated femoral stems with MoM, ceramic on ceramic (CoC) and metal on polyethylene (MoP) bearing couples. A single-centre implant retrieval lab reviewed 44 hydroxyapatite (HA)-coated titanium wedge taper stems of the same design retrieved over a period of 9 years. Ten were MoM articulations, 23 MoP and 11 CoC. Head sizes ranged from 28 to 40 with only four 40mm heads, all of which were MoM. Reason for revision, duration of implantation, femoral head size, patient age and body mass index was recorded for each retrieval. Goldberg corrosion scores were determined for the taper surfaces of each retrieval, with ‘0’ indicating no corrosion and ‘3’ indicating severe corrosion. Logistic regression analysis, Wilcoxan Rank Sum and Fischer's exact test were used for statistical analysis. Aseptic loosening was the listed reason for revision in 18 of 44 cases. MoM bearing was associated with increased probability of aseptic loosening (Odds ratio 7.1 (95%CI 1.1–47.0) p=0.042). Severity of corrosion was also associated with aseptic loosening (Odds ratio 2.75 (95%CI 1.1–6.6) p=0.02). Head size and patient age had no correlation. Median time to revision of implants for aseptic loosening was 4.5 years (range: 4.2–7.0 years) for MoM versus 1.4 years (range: 0.3–3.0) for other bearing couples (p=0.004). Aseptic loosening was categorised as early (<=2 years) or mid-term (>2 years). No MoM hips were revised for aseptic loosening in the first 2 years while 8 of the 11 mid-term revisions had MoM articulations (p=0.004). Taper corrosion was more severe in mid-term aseptic loosing cases (p=0.049). MoM HA-coated hip replacements appear to be associated with increased mid-term aseptic loosening compared to other bearing couples. Patients with MoM HA-coated hip replacements should be monitored regularly beyond the initial 1 to 2 years following surgery. Future analyses will examine the presence and progression of femoral radiolucency prior to revision surgery to determine an approximate timeline of stem loosening in this patient cohort. This research highlights the importance of implant retrieval programs to assess post-revision implant characteristics for early identification of possible device issues.
Articulation of the polyethylene (PE) insert between the metal femoral and tibial components in total knee replacements (TKR) results in wear of the insert which can necessitate revision surgery. Continuous PE advancements have improved wear resistance and durability increasing implant longevity. Keeping up with these material advancements, this study utilises model-based radiostereometric analysis (mbRSA) as a tool to measure Radiographic data was collected from the QEII Health Sciences Centre in Halifax, NS. Data consisted of follow-up RSA examinations at post-operative, six-, 12-, and 24-month time periods for 72 patients who received a TKR. Implanted in all patients were Stryker Triathlon TKRs with a fixed, conventional PE bearing of either a cruciate retaining or posterior stabilised design. Computer-aided design (CAD) implant models were either provided by the manufacturer or obtained from 3D scanned retrieved implants. Tibial and femoral CAD models were used in mbRSA to capture pose data in the form of Cartesian coordinates at all follow-ups for each patient. Coordinate data was manually entered into a 3D modeling software (Geomagic Studio) to position the implant components in virtual space as presented in the RSA examinations. PE wear was measured over successive follow-ups as the linear change in joint space, defined as the shortest distance between the tibial baseplate and femoral component, independently for medial and lateral sides. A linear best-fit was applied to each patient's wear data; the slope of this line determined the annual wear rate per individual patient. Wear rates were averaged to provide a mean rate of Mean linear wear per annum across all 72 patients was 0.088mm/yr (SD: 0.271 mm/yr) for the medial condyle and 0.032 mm/yr (SD: 0.230 mm/yr) for the lateral condyle. Cumulative linear wear at the 2-year follow-up interval was 0.207mm (SD: 0.565mm) and 0.068mm (SD: 0.484mm) for the medial and lateral condyles, respectively. Linear PE wear measurements using mbRSA and Geomagic Studio resulted in 0.056mm/yr additional wear on the medial condyle than the lateral condyle. Large standard deviations for yearly wear rates and cumulative measurements demonstrate this method does not yet exhibit the accuracy needed to provide short-term in vivo wear measurement. Inter-patient variability from RSA examinations is likely a source of error when dealing with such small units of measure. Further analysis on patient age and body mass index may eliminate some variability in the data to improve accuracy. Despite high standard deviations, the results from this research are in proximity to previously reported linear wear measurements 0.052mm/yr and 0.054mm/yr. Linear wear analysis will continue upon completion of >100 patients, in addition to volumetric PE wear over the entire articulating surface.
Ceramic-on-ceramic (C-C) total hip replacements (THRs) are an attractive option for young, active patients [1, 2]. However, more clinical data is necessary to establish the reasons of failure of contemporary C-C THRs in vivo. The objective of the present study was to assess the surface damage on retrieved C-C THRs and determine possible influential factors that may explain their in vivo performance. Thirty-five C-C retrievals of material type Biolox® forte (n=28) and Biolox® delta (n=7) (CeramTec AG, Plochingen, Germany) were collected after a mean of 3.7 ± 3.2 years in vivo. Semi-quantitative surface damage assessment [3] was performed on all retrievals to obtain both a damage score (DS) (Fig. 1). Contact profilometry was performed on the retrieved femoral heads to characterize the type of surface damage (metal transfer, stripe wear). Scanning electron microscope (SEM) images were obtained from two femoral heads displaying areas of typical surface damage. The implantation period correlated with the damage score (DS) of the femoral heads (R=0.573, p<0.001) and the acetabular cups (R=0.592, p<0.001). However, the metal transfer DS of the femoral heads did not correlate with implantation period (R=0.185, p=0.29). Surface roughness of metal-transfer areas were positively skewed (additive metal transfer) while the stripe damage areas were negatively skewed (grain removal), as evidenced by SEM analysis. Stripe damage was observed on both the Biolox® forte and Biolox® delta retrieved femoral heads; however, the extent of grain removal appeared less severe on the Biolox® delta retrieved femoral heads due to their overall smaller grain size (Fig. 2). Inclination angles > 45° was associated with a greater DS rate [DS/time of implantation], which had also been suggested elsewhere [4]. Four patients reported squeaking in their C-C THRs; one of which was a 54 yr-old male patient who completed three full marathons with his implant. In this his case, the DS for this retrieval was below average, with metal-transfer being the only macroscopic damage feature. Fracture of the acetabular liner occurred in three patients, all of which had malpositioned components. Metal-transfer on the ceramic surface could possibly cause a local break down of the fluid film and may facilitate, in addition to an increased inclination angle, stripe damage via an adhesive wear mechanism. Therefore, direct contact between the Ti-alloy acetabular shell and the ceramic femoral head should be avoided at primary surgery. C-C THRs remain an attractive option for young, active patients, but care must be taken during implantation to appropriately position the acetabular cup and to avoid unwanted metal-transfer as such alteration at the bearing interface may change implant tribology.
