Adrian Taylor

Computer navigation versus conventional total knee replacement: no difference in functional results at two years.

We previously compared the component alignment in total knee replacement using a computer-navigated technique with a conventional jig-based method. We randomly allocated 71 patients to undergo either computer-navigated or conventional replacement. An improved alignment was seen in the computer-navigated group. The patients were then followed up post-operatively for two years, using the Knee Society score, the Short Form-36 health survey, the Western Ontario and McMaster Universities osteoarthritis index, the Bartlett Patellar pain questionnaire and the Oxford knee score, to assess functional outcome. At two years post-operatively 60 patients were available for assessment, 30 in each group and 62 patients completed a postal survey. No patient in either group had undergone revision. All variables were analysed for differences between the groups either by Students t-test or the Mann-Whitney U test. Differences between the two groups did not reach significance for any of the outcome measures at any time point. At two years postoperatively, the frequency of mild to severe anterior pain was not significantly different (p = 0.818), varying between 44% (14) for the computer-navigated group, and 47% (14) for the conventionally-replaced group. The Bartlett Patellar score and the Oxford knee score were also not significantly different (t-test p = 0.161 and p = 0.607, respectively). The clinical outcome of the patients with a computer-navigated knee replacement appears to be no different to that of a more conventional jig-based technique at two years post-operatively, despite the better alignment achieved with computer-navigated surgery.

Lymphocyte proliferation responses in patients with pseudotumors following metal-on-metal hip resurfacing arthroplasty

Locally destructive soft tissue pseudotumor has been reported in patients following metal‐on‐metal hip resurfacing arthroplasty (MoMHRA). A delayed hypersensitivity reaction type IV to nickel (Ni), chromium (Cr), or cobalt (Co) has been suggested to play a role in its aetiology. The aim of this study was to investigate the incidence and level of metal‐induced systemic hypersensitivity in patients with MoMHRA, both with and without pseudotumor by measuring lymphocyte proliferation responses to metals. A total of 92 patients were investigated: (1) MoMHRA patients with pseudotumors (nine female, one male); (2) MoMHRA patients without pseudotumors (30 female, 30 male); and (3) age‐matched control subjects without metal implants (9 female, 13 male). The venous blood samples were collected for serum Ni, Co, and Cr ion level measurements and lymphocyte transformation tests (LTT). A higher incidence and level of enhanced lymphocyte reactivity only to Ni was found in patients with MoMHRA compared to the patients without MoM implants, reflecting exposure and immune reactivity. However, lymphocyte reactivity to Co, Cr, and Ni did not significantly differ in patients with pseudotumors compared to those patients without pseudotumors. This suggests that systemic hypersensitivity type IV reactions, as measured by lymphocyte proliferation response to these metals, may not be the dominant biological reaction involved in the occurrence of the soft tissue pseudotumors.

The seven-year wear of highly cross-linked polyethylene in total hip arthroplasty: a double-blind, randomized controlled trial using radiostereometric analysis.

BACKGROUND The use of highly cross-linked polyethylene is now commonplace in total hip arthroplasty. Hip simulator studies and short-term in vivo measurements have suggested that the wear rate of highly cross-linked polyethylene is significantly less than that of conventional ultra-high molecular weight polyethylene. However, long-term data to support its use are limited. The aim of this study was to compare the intermediate-term steady-state wear of highly cross-linked polyethylene compared with that of conventional ultra-high molecular weight polyethylene acetabular liners in a prospective, double-blind, randomized controlled trial with use of radiostereometric analysis. METHODS Fifty-four patients were randomized to receive hip replacements with either conventional ultra-high molecular weight polyethylene acetabular liners (Zimmer) or highly cross-linked polyethylene liners (Longevity; Zimmer). All patients received a cemented, collarless, polished, tapered femoral component (CPT; Zimmer) and an uncemented acetabular component (Trilogy; Zimmer). Clinical outcomes were assessed and the three-dimensional penetration of the head into the socket was determined for a minimum of seven years. Linear regression was used to calculate the steady-state wear rate following the creep-dominated penetration seen during the first year. RESULTS At a minimum of seven years postoperatively, the mean total femoral head penetration was significantly lower in the highly cross-linked polyethylene group (0.33 mm; 95% confidence interval [CI], ±0.10 mm) than it was in the ultra-high molecular weight polyethylene group (0.55 mm; 95% CI, ±0.10 mm) (p = 0.005). The mean steady-state wear rate of highly cross-linked polyethylene was 0.005 mm/yr (95% CI, ±0.015 mm/yr), compared with 0.037 mm/yr (95% CI, ±0.019 mm/yr) for conventional ultra-high molecular weight polyethylene (p = 0.007). No patient in the highly cross-linked polyethylene group had a wear rate above the osteolysis threshold of 0.1 mm/yr, compared with 9% of patients in the ultra-high molecular weight polyethylene group. CONCLUSIONS This study demonstrates that highly cross-linked polyethylene has a significantly lower steady-state wear rate compared with that of conventional ultra-high molecular weight polyethylene. Longer-term follow-up is required to determine if this will translate into improved clinical performance and longevity of these implants.

The John Charnley Award: Highly crosslinked polyethylene in total hip arthroplasty decreases long-term wear: a double-blind randomized trial.

T he last few years have seen several disasters in hip arthroplasty which, as recently as 2007, had rightly been described in The Lancet [3] as ‘‘the operation of the century.’’ But the withdrawal of the DePuy ASR (DePuy Inc, Warsaw, IN, USA) metal-on-metal (MoM) hip in August 2010, after almost 100,000 had been implanted worldwide, simply served as the precursor to problems with other MoM hips, of which hundreds of thousands have been implanted into patients. While the first ASR cases in the United States may have settled, legal proceedings in other countries are ongoing. Additionally, higher-thanexpected revision rates with other designs of MoM hips have seen legal proceedings commence. Problems have also been identified with modular-neck hip implants, which raised several pertinent questions as to how such implants came to market, how they were tested in vitro, whether the 510 k/ CE marking procedure was effective, and how quickly were clinical problems identified and acted on. Given such a turbulent background, it may be that new implants, which are claimed to be innovative, should be treated with additional caution. It may also be that orthopaedic surgeons will now look to technologies that have been proven during longer timescales. As such, the clinical results offered in the paper by Thomas and colleagues are to be welcomed.

The in vivo linear and volumetric wear of hip resurfacing implants revised for pseudotumor.

BACKGROUND Metal-on-metal arthroplasty-related pseudotumors can cause severe local destruction of bone and soft tissues. The cause of pseudotumors is unknown, although some authors have implicated metal wear debris. The aim of this study was to measure the location and magnitude of wear on resurfacing devices that were retrieved during revision procedures for pseudotumor (the pseudotumor group) and for other reasons (the control group). METHODS We examined thirty-six hip-resurfacing implants, which were divided into two groups: eighteen implants from patients with a diagnosis of pseudotumor and eighteen control implants. Implant orientation and patient demographics were recorded. Three-dimensional, contactless metrology was used to scan the surface of the femoral and acetabular components to a resolution of 20 nm. Linear and volumetric wear were measured, and the components were examined for evidence of edge wear. RESULTS There was three times more total linear wear and over six times more total volumetric wear of the femoral and acetabular components in the pseudotumor group as compared with that in the control group. The mean linear wear rate and standard deviation of the femoral components in the pseudotumor group (8.4 ± 8.7 μm/yr) were significantly greater than those in the control group (2.9 ± 3.9 μm/yr; p = 0.01). The mean volumetric wear rate of the femoral components was also significantly greater in the pseudotumor group (3.3 ± 5.7 mm3/yr) than it was in the control group (0.8 ± 1.2 mm3/yr; p = 0.009). Seventeen of eighteen subjects in the pseudotumor group had edge wear, compared with six of eighteen in the control group (p < 0.001). CONCLUSIONS Implants that were retrieved because of pseudotumor had a significantly higher wear rate and prevalence of edge wear than the control implants did. There was a strong association between pseudotumor and the high levels of wear debris that are generated during edge-loading. However, not all patients with high wear developed pseudotumors, and not all pseudotumors had high wear; therefore, other factors are most likely involved in the cause of pseudotumors.

Primary hip replacement prostheses and their evidence base: systematic review of literature

Objective To determine the extent to which prostheses with no readily available evidence to support their use are being implanted in primary total hip arthroplasty. Design Systematic review of the literature. Data sources The 9th annual report of the National Joint Registry of England and Wales (NJR) was analysed to identify prostheses with an Orthopaedic Data Evaluation Panel rating of “unclassified” or “pre-entry” used in primary total hip arthroplasty in 2011. A systematic review of those prostheses was carried out using PubMed, Cochrane, Embase, OVID, and Google databases. Study selection Prostheses used in primary total hip arthroplasty as published in the NJR’s 9th annual report were analysed. Only literature that included the name of the prosthesis was included. Literature yielded in the search results was excluded if it reported animal, non-orthopaedic, non-total hip arthroplasty, or non-device related studies. Results The systematic review found that 24% (57/235) of all hip replacement implants available to surgeons in the UK have no evidence for their clinical effectiveness. It also shows that 10 617 (7.8%) of the 136 593 components used in primary hip replacements in 2011 were implanted without readily identifiable evidence of clinical effectiveness. These comprised 157 cemented stems (0.5% of 34 655 implanted), 936 (2.8% of 33 367) uncemented stems, 1732 (7.1% of 24 349) cemented cups, and 7577 (17.1% of 44 222) uncemented cups. Conclusions This study shows that a considerable proportion of prostheses available to orthopaedic surgeons have no readily available evidence of clinical effectiveness to support their use. Concern exists about the current system of device regulation, and the need for a revised process for introducing new orthopaedic devices is highlighted.

Pelvic position and movement during hip replacement

The orientation of the acetabular component is influenced not only by the orientation at which the surgeon implants the component, but also the orientation of the pelvis at the time of implantation. Hence, the orientation of the pelvis at set-up and its movement during the operation, are important. During 67 hip replacements, using a validated photogrammetric technique, we measured how three surgeons orientated the patients pelvis, how much the pelvis moved during surgery, and what effect these had on the final orientation of the acetabular component. Pelvic orientation at set-up, varied widely (mean (± 2, standard deviation (sd))): tilt 8° (2sd ± 32), obliquity -4° (2sd ± 12), rotation -8° (2sd ± 14). Significant differences in pelvic positioning were detected between surgeons (p < 0.001). The mean angular movement of the pelvis between set-up and component implantation was 9° (sd 6). Factors influencing pelvic movement included surgeon, approach (posterior > lateral), procedure (hip resurfacing > total hip replacement) and type of support (p < 0.001). Although, on average, surgeons achieved their desired acetabular component orientation, there was considerable variability (2sd ± 16) in component orientation. We conclude that inconsistency in positioning the patient at set-up and movement of the pelvis during the operation account for much of the variation in acetabular component orientation. Improved methods of positioning and holding the pelvis are required.

Molecular Diagnosis of Orthopedic-Device-Related Infection Directly from Sonication Fluid by Metagenomic Sequencing

ABSTRACT Culture of multiple periprosthetic tissue samples is the current gold standard for microbiological diagnosis of prosthetic joint infections (PJI). Additional diagnostic information may be obtained through culture of sonication fluid from explants. However, current techniques can have relatively low sensitivity, with prior antimicrobial therapy and infection by fastidious organisms influencing results. We assessed if metagenomic sequencing of total DNA extracts obtained direct from sonication fluid can provide an alternative rapid and sensitive tool for diagnosis of PJI. We compared metagenomic sequencing with standard aerobic and anaerobic culture in 97 sonication fluid samples from prosthetic joint and other orthopedic device infections. Reads from Illumina MiSeq sequencing were taxonomically classified using Kraken. Using 50 derivation samples, we determined optimal thresholds for the number and proportion of bacterial reads required to identify an infection and confirmed our findings in 47 independent validation samples. Compared to results from sonication fluid culture, the species-level sensitivity of metagenomic sequencing was 61/69 (88%; 95% confidence interval [CI], 77 to 94%; for derivation samples 35/38 [92%; 95% CI, 79 to 98%]; for validation samples, 26/31 [84%; 95% CI, 66 to 95%]), and genus-level sensitivity was 64/69 (93%; 95% CI, 84 to 98%). Species-level specificity, adjusting for plausible fastidious causes of infection, species found in concurrently obtained tissue samples, and prior antibiotics, was 85/97 (88%; 95% CI, 79 to 93%; for derivation samples, 43/50 [86%; 95% CI, 73 to 94%]; for validation samples, 42/47 [89%; 95% CI, 77 to 96%]). High levels of human DNA contamination were seen despite the use of laboratory methods to remove it. Rigorous laboratory good practice was required to minimize bacterial DNA contamination. We demonstrate that metagenomic sequencing can provide accurate diagnostic information in PJI. Our findings, combined with the increasing availability of portable, random-access sequencing technology, offer the potential to translate metagenomic sequencing into a rapid diagnostic tool in PJI.

The feasibility of performing a randomised controlled trial for femoroacetabular impingement surgery.

Objectives The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI. Methods Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31). Results Clinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance. Conclusions We conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms.

Metal-on-metal hip resurfacings—a radiological perspective

It is important to be aware of the various complications related to resurfacing arthroplasty of the hip (RSA) and the spectrum of findings that may be encountered on imaging. The bone conserving metal-on-metal (MOM) hip resurfacing has become increasingly popular over the last ten years, especially in young and active patients. Initial reports have been encouraging, but long-term outcome is still unknown. Early post operative complications are rare and have been well documented in the literature. Medium and long term complications are less well understood. A rare but important problem seen at this stage is the appearance of a cystic or solid periarticular reactive mass, which occurs predominately in women and usually affects both hips when seen in patients with bilateral RSAs. The following imaging findings are illustrated and their significance discussed; Uncomplicated hip resurfacing arthroplasty, radiolucency around the femoral peg, femoral neck fracture, loosening and infection, suboptimal component position, femoral notching, dislocation, heterotopic ossification, femoral neck thinning and reactive masses. The radiologist should be aware of the normal radiographic appearances and the variety of complications that may occur following RSA and should recommend ultrasound or MRI in patients with an unexplained symptomatic hip and normal radiographs.