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The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 61 - 61
1 Sep 2012
Gulihar A Taylor G Hadi M
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Background. There are several case reports of chondrolysis following joint arthroscopy. Continuous post-operative infusion of local anaesthetic solutions, especially 0.5% Bupivacaine, has been implicated as the causative factor in many of these cases. Recent in vitro studies have shown that even a single exposure of articular cartilage to different local anaesthetic solutions can cause apoptosis and mitochondrial dysfunction in chondrocytes leading to cell death. There is currently no study looking at methods to prevent this toxicity of local anaesthetic solutions to articular cartilage. Glucosamine has a protective and reparative effect on articular cartilage and a Cochrane review in 2007 found that it provides mild benefit in pain and function in patients with arthritis. Aims. Oncologic: To compare the effect of a single exposure, in vitro, of different local anaesthetic solutions on human articular cartilage. To investigate the protective and reparative effects of Glucosamine on articular cartilage exposed to 0.5% Bupivacaine. Methods. Chondral explants (n = 354) were obtained from femoral heads of 14 fracture neck of patients undergoing hemiarthroplasty. To compare the effect of local anaesthetics, each specimen was exposed to one of 8 test solutions for one hour. After this exposure, the specimens were washed and incubated in culture medium containing radio-labelled 35-sulphur for 16 hours. The unbound radioactivity was then washed off and the chondral specimens were digested with proteinase for 24 hours. The uptake of 35-S by each specimen was measured and this gave an estimate of proteoglycan metabolism. Test solutions: 1. 1% Lidocaine; 2. 2% Lidocaine; 3. 0.25% Bupivacaine; 4. 0.5% Bupivacaine,. 5. 0.5% Levo-Bupivacaine; 6. Control solution of M199 culture medium. 7. To investigate its protective effect, 100 micrograms of Glucosamine was added along with 0.5% Bupivacaine; 8. To investigate the reparative effect of Glucosamine, the specimen was exposed to 0.5% Bupivacaine for one hour. After washing, 100 mcg of Glucosamine was added to the culture medium in which the chondral specimen was incubated. Results. Compared to the control culture medium, the inhibition of proteoglycan metabolism was 54% with 1% Lidocaine (p<0.001), 75% with 2% Lidocaine (p<0.01), 50% with 0.25% Bupivacaine (p = 0.04), 78% with 0.5% Bupivacaine (p<0.001) and 73% with 0.5% Levo-Bupivacaine (p<0.001). Adding Glucosamine for protection reduced the toxicity of 0.5% Bupivacaine to 43%, compared to 78% without. However, Glucosamine was not able to repair the damage caused by 0.5% Bupivacaine, with inhibition of proteoglycan metabolism at 70% even after 16 hours of incubation. Conclusion. All local anaesthetic solutions tested were toxic to articular cartilage, 0.5% Bupivacaine being the worst offender. Higher concentrations were more harmful. The addition of Glucosamine to 0.5% Bupivacaine protected against its toxicity to articular cartilage but was not able to repair the damage caused


Bone & Joint Open
Vol. 4, Issue 7 | Pages 516 - 522
10 Jul 2023
Mereddy P Nallamilli SR Gowda VP Kasha S Godey SK Nallamilli RR GPRK R Meda VGR

Aims

Musculoskeletal infection is a devastating complication in both trauma and elective orthopaedic surgeries that can result in significant morbidity. Aim of this study was to assess the effectiveness and complications of local antibiotic impregnated dissolvable synthetic calcium sulphate beads (Stimulan Rapid Cure) in the hands of different surgeons from multiple centres in surgically managed bone and joint infections.

Methods

Between January 2019 and December 2022, 106 patients with bone and joint infections were treated by five surgeons in five hospitals. Surgical debridement and calcium sulphate bead insertion was performed for local elution of antibiotics in high concentration. In all, 100 patients were available for follow-up at regular intervals. Choice of antibiotic was tailor made for each patient in consultation with microbiologist based on the organism grown on culture and the sensitivity. In majority of our cases, we used a combination of vancomycin and culture sensitive heat stable antibiotic after a thorough debridement of the site. Primary wound closure was achieved in 99 patients and a split skin graft closure was done in one patient. Mean follow-up was 20 months (12 to 30).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 244 - 244
1 Sep 2012
Thomassen B Pool L Van Der Flier R Stienstra R
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High volume infiltration with local anaesthetics (LIA) during total knee arthroplasty (TKA) for postoperative pain relief may be beneficial as compared to traditional methods. Retransfusion drains are used in TKA as alternative for allogeneic blood transfusions. When combining both modalities, recollected blood may contain large doses of local anaesthetics potentially leading to systemic toxicity during retransfusion. We investigated the safety of combining LIA and retransfusion of shed blood. Twenty patients scheduled for primary TKA were included. During surgery two peri-articular injections with ropivacaine (total 375 mg) were given. Patients received an intraarticular retransfusion drain and a wound catheter for continuous infusion of ropivacaine (8 mg/hr) for 24 hours. Blood collected in the retransfusion device, was not retransfused but used for laboratory analyses. Patients’ blood samples were taken immediately after surgery, 3, 6 and 24 hours postoperatively. We predicted cumulative ropivacaine concentrations using patient and shed blood samples from 6 hours postoperatively. We modelled instant retransfusion by estimating the cumulative plasma concentrations. Our safety threshold was 0.15 mg/L unbound ropivacaine in a venous plasma sample, based on literature. Total ropivacaine concentration was highest 24 hours postoperatively and unbound ropivacaine was maximal predominantly at 6 hours. Total ropivacaine concentrations ranged from 0.7 to 1.9 mg/L and unbound ropivacaine concentrations varied between 0.03 and 0.11 mg/L. At 6 hours median shed blood volume was 600 mL (range 303–869 mL). Interestingly was the difference (mean ± SD) in free fraction ropivacaine, in shed blood (68.8–4.6%) and in plasma (4.8 ± 1.1%). Assuming retransfusion, an average 13 mg (range 6–18mg) of unbound ropivacaine would have been administered intravenously. The model used to estimate cumulative ropivacaine plasma levels showed that instant retransfusion potentially would have led to unbound venous plasma concentrations of above 0.15 mg/L. Under the conditions in our study it is safe to use LIA in combination with continuous infusion of ropivacaine. However, in combination with the retransfusion of shed blood collected with the Bellovac ABT system this may lead to toxic levels. Before implementing the combination of both modalities formal testing is required


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 572 - 572
1 Sep 2012
Khan A Ebreo D El Meligy M Armstrong C Peter V
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Introduction. The advantages of metal on metal (MOM) hip replacement are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri prosthetic osteolysis generated as a result of a biological response to particulate wear debris. Our aim in this study was to determine whether a steeply inclined acetabular component would give rise to a higher concentration of metal ions. Patients and methods. Between April 2003 and June 2006, 22 patients had MOM hip replacement for osteoarthritis by a single Surgeon. There were 12 male and 10 female patients. The average age at the time of surgery was 56 years (Range: 44–69 years). We divided the 22 patients into 2 groups, one group (A) of 11 patients with the acetabular inclination angle more than 50 degrees and the other group (B) of 11 patients with the angle less than 50 degrees. The inclination of the acetabular cup was measured using a standard AP radiograph of the pelvis. The patients had metal ion levels (blood chromium and serum cobalt) measured at an average follow up of 3.2 years (Range 2.4 to 5 years). Results. Mean blood chromium level in the group A (146 nM/L) was significantly higher (p=0.005) than in Group B (92 nM/L). Mean serum cobalt level in the group A (245 nM/L) was significantly higher (p=0.002) than in Group B (110 nM/L). Discussion. The early to mid term published results of MOM hip replacements have been encouraging. There are, however, a number of concerns about the MOM bearing. Although its wear rate is low, it still releases metal ions into the body particularly cobalt and chromium since most metal on metal bearings are made of a cobalt chromium alloy. The long-term consequences of increased levels of these ions in the body are not known. High concentrations of Co and Cr are toxic and are known to interfere with a number of biological functions. There also have been recent reports of soft tissue reactions with MOM hip replacement. In the light of these concerns, it is important to examine factors which may influence the release of metal ions after MOM hip replacement. It has been reported in the recent literature that the position of the acetabular component will influence the bearing wear inturn leading to the release of metal ions after MOM hip replacement. Our findings indicate that steeply inclined acetabular components with an inclination angle greater than 50 degrees gives rise to higher concentration of metal ions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 224 - 224
1 Sep 2012
Ebreo D Khan A El-Meligy M Armstrong C Peter V
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INTRODUCTION. The advantages of large diameter metal on metal total hip arthroplasty (MoM THA) and hip resurfacing arthroplasty are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri-prosthetic osteolysis generated as a result of a biological response to particulate wear debris. No reports in the literature exist as to whether circulating levels of Chromium (Cr) and Cobalt (Co) decrease upon removal of a symptomatic large diameter MoM implant or whether levels remain high due to the effect of metal ions debris left behind in the soft tissues after revision surgery. PATIENTS AND METHODS. Between June 2006 and June 2009 we undertook 44 revision surgeries of both large head MoM THAs (femoral head diameter 38mm) and metal-on-metal hip resurfacings for suspected metallosis. Mean time from original implant to revision was 4 years, 8 months (1yr 4mo–7yr 9mo). The mean follow up evaluation was 2 years and 2 months (1yr 2mo–4 years). Blood samples were taken for whole blood Cr and serum Co according to a recognised protocol and compared with reference levels indicated by the Medicines and Healthcare Regulatory Agency recommendation of less than 7ppb for Cr (130nM/L) and Co (119nM/L). RESULTS. 42 patients were found to have histological evidence of either metal allergy, metal toxicity or foreign body reaction. 2 patients had evidence of infection with no features of metal reaction. 3 patients suffered early dislocation requiring closed reduction. 1 patient had infective complications necessitating Girdlestones. 11 patients were lost to follow up, 8 patients were diagnosed pre operatively on Co and Cr levels in urine or synovial fluid aspirate alone. 23 patients had pre revision blood or serum metal ion level results available for direct comparison. Median serum Co level pre revision was 176.6nM/L, falling post revision to 5.1nM/L (p=<0.001∗). The median whole blood Cr level pre revision was 117nM/L and 19nm/L post revision (p=<0.001∗). Mean Oxford Hip Score was 23.7. DISCUSSION. This study demonstrates that at greater than one year post removal of a large diameter MoM hip implant for the indication of symptomatic metallosis or metal hypersensitivity, metal ion levels fall to almost normal levels and that outcome of revision surgery in terms of patient satisfaction is not adversely affected


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_8 | Pages 9 - 9
1 May 2018
Haque S Soufi M Jayaraman S Barzo F Shoaib A
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Background. Medical grade Calcium Sulphate can be used as a delivery vehicle for antibiotics. We use these for treating patients with established osteomyelitis, but also use it prophylactic for contaminated war injuries, to fill voids in bone with osteo conductve filler that delivers local antibiotics, and can integrate with bone. Although antibiotic loaded calcium sulphate is increasingly used, there is little data to demonstrate that systemic levels generated by local release of antibiotics are safe. For this reason, we routinely assay systemic levels of antibiotics. Objectives. To determine if systemic toxicity occurs after the use of antibiotic loaded calcium sulphate in the treatment of bone and soft tissue infection. Material and Method. Bone cavities and soft tissue dead spaces were aggressively debrided, lavaged and packed with Calcium Sulphate (10–40 cc) loaded with Vancomycin (1–4 g) and Gentamicin (240–960 mg). Post-operatively serial assays of Vancomycin and Gentamicin levels 1 hour after surgery then daily for three days. Renal function was also measured. Results. In patients with normal renal function. : The systemic levels were either un-measurable at the first assay, or below the acceptable trough level (Mean 2.4 and 1.8 for Vancomycin and Gentamycin respectively). They had measurable systemic levels at the third assay . In patients with renal dysfunction. : Systemic levels were in the therapeutic range determined for systemically administered antibiotics, but these levels remained high and did not decrease until patients had undergone their routine dialysis. Conclusions. In patients treated with antibiotic loaded Calcium Sulphate: Antibiotic assays are not necessary in patients who have normal renal function. Patients with impaired renal function should have:. Use lower doses of antibiotics. Should undergo assays routinely. Ensure dialysis after surgery. If they remain high, the antibiotic loaded calcium sulphate could be removed


The Bone & Joint Journal
Vol. 97-B, Issue 10 | Pages 1423 - 1427
1 Oct 2015
Rand BCC Penn-Barwell JG Wenke JC

Systemic antibiotics reduce infection in open fractures. Local delivery of antibiotics can provide higher doses to wounds without toxic systemic effects. This study investigated the effect on infection of combining systemic with local antibiotics via polymethylmethacrylate (PMMA) beads or gel delivery. An established Staphylococcus aureus contaminated fracture model in rats was used. Wounds were debrided and irrigated six hours after contamination and animals assigned to one of three groups, all of which received systemic antibiotics. One group had local delivery via antibiotic gel, another PMMA beads and the control group received no local antibiotics. After two weeks, bacterial levels were quantified. . Combined local and systemic antibiotics were superior to systemic antibiotics alone at reducing the quantity of bacteria recoverable from each group (p = 0.002 for gel; p = 0.032 for beads). There was no difference in the bacterial counts between bead and gel delivery (p = 0.62). . These results suggest that local antibiotics augment the antimicrobial effect of systemic antibiotics. Although no significant difference was found between vehicles, gel delivery offers technical advantages with its biodegradable nature, ability to conform to wound shape and to deliver increased doses. Further study is required to see if the gel delivery system has a clinical role. Cite this article: Bone Joint J 2015;97-B:1423–7


Bone & Joint Open
Vol. 3, Issue 4 | Pages 284 - 290
1 Apr 2022
O'Hara NN Carullo J Joshi M Banoub M Claeys KC Sprague S Slobogean GP O'Toole RV

Aims

There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients.

Methods

This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_17 | Pages 6 - 6
1 Dec 2015
Carter T Tsirikos A
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Scheuermann's kyphosis is a structural deformity of the thoracic or thoracolumbar spine, which can result in severe pain, neurological compromise and cosmetic dissatisfaction. Modern surgical techniques have improved correction through a posterior-only or antero-posterior approach but can result in significant morbidity. We present our results of the surgical management of severe Scheuermann's kyphosis by a single surgeon with respect to deformity correction, global balance parameters, functional outcomes and complications at latest follow-up. We included 49 patients, of which 46 had thoracic and 3 had thoracolumbar kyphosis. Surgical indications included persistent back pain, progressive deformity, neurological compromise and poor self-image. Fourty-seven patients underwent posterior-only and 2 antero-posterior spinal arthrodesis utilising Chevron-type osteotomies and hybrid instrumentation. Mean age at surgery was 16.0 years with mean postoperative follow-up of 4.5 years. Mean kyphosis corrected from 92.1o to 46.9o (p<0.001). Concomitant scoliosis was eliminated in all of the 28 affected patients. Coronal and sagittal balance was corrected in all patients. Mean blood loss was 24% total blood volume. Mean operation time was 4.3 hours with mean inpatient stay of 9 days. SRS-22 questionnaire improved from a mean preoperative score of 3.4 to 4.6 at 2 years, with high treatment satisfaction rates. Complications included one toxic septicaemia episode but otherwise no wound infections, no junctional deformity, no loss of correction and no requirement for re-operation. Posterior spinal arthrodesis with the use of hybrid instrumentation can safely achieve excellent correction of severe Scheuermann's kyphosis helping to relieve back pain, improve functional outcomes and enhance self-image


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIII | Pages 11 - 11
1 Jul 2012
Smith I Cyrulik K Amyes S Simpson A Hall A
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In some centres, serial bedside aspirations, in association with intravenous antibiotics, are still an accepted treatment for septic arthritis (Mathews, Postgraduate Medical Journal, 2008). However, there is a risk that bacterial products remain in the joint, even when the bacteria have been destroyed. We have conducted a study to ascertain whether bacterial products alone have an effect on in situ chondrocyte viability. A hip aspirate (25μl), containing Staphylococcus aureus, from a patient with septic arthritis was added to 5ml culture medium and incubated (37°C) for 48hrs. The solution was then centrifuged (3400g for 10mins) and the supernatant removed. Cartilage explants were harvested from a bovine metacarpophalangeal joint, placed into the bacterial supernatant and incubated at 37°C. Explants were removed at hourly intervals over a 6-hour period and stained with the fluorescent probes chloromethylfluorescein di-acetate (10μM) and propidium iodide (10μM) to label living chondrocytes green and dead cells red respectively. Following imaging of cartilage by confocal microscopy, the percentage cell death at each time point was obtained using Volocity 4 software. Chondrocyte death increased markedly with time: 0.04% at 2hrs, 28% at 4hrs and 39% at 6hrs. This study shows that bacterial products rapidly penetrate the cartilage matrix and have a damaging effect on in situ chondrocyte viability. Further work will clarify the contributions made by the various toxic components in the culture supernatant, but these data support the need to remove the bacteria and their products aggressively as part of the treatment of septic arthritis


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 79 - 79
1 Sep 2012
Wahl P Livio F Jacobi M Gautier E Buclin T
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Introduction. Calcium sulphate is a resorbable void filler that can be used for local antibiotic delivery. Results from clinical studies on chronic osteomyelitis thus treated with local vancomycin have already been published. Despite significant exposure to this drug, there are no pharmacokinetic studies published so far. Based on observations in our patients, a model predicting vancomycin serum and wound fluid levels and toxicity potential is presented. Methods. Following implantation of Osteoset® added with vancomycin, serum and wound fluid concentrations of this antibiotic have been monitored systematically. The pharmacokinetic analysis was performed using a non-linear mixed-effects model based on a one-compartment model with first-degree absorption. Results. Data from 43 patients treated between October 2006 and August 2010 were analysed. Serum concentrations remained far below the usually accepted trough levels of 10 mg/L, and were still acceptable in two cases of post-operative renal failure. Wound fluid concentrations around 1,000 mg/l were observed for the first 7–10 days, and remained above usual minimal inhibitory concentrations for approximately a month. Discussion and Conclusion. This is the first pharmacokinetic exploration of calcium sulphate added with vancomycin for local antibiotic therapy. The systemic exposure to vancomycin is low and appears safe even after implantation of up to 6 g vancomycin, except in case of markedly impaired renal function. Wound fluid concentrations of vancomycin appear extremely interesting for further studies


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIII | Pages 17 - 17
1 Jul 2012
Murray O Lee S Mckenna R Kelly M Roberts J
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Early failure of metal-on-metal (MoM) total hip replacements (THR) is now well established. We review 93 consecutive patients with CPT¯ stems MoM THR. Our series demonstrates a new mechanism of failure, which may be implant combination specific. Between January 2005 and June 2009, 93 consecutive MoM total hip replacements were preformed using CPT stems by 3 surgeons at our unit. 73 CPT¯ stems, Metasul¯ Large Diameter Heads (LDH) with Durom¯ acetabulae and 20 CPT¯ stems, Metasul¯ 28mm diameter heads in Allofit¯ shells (zimmer). Clinical outcomes were collected prospectively before surgery, at 3 months, 1 year, 2 years, 3 years, and at 5 years post surgery. Revision for any cause was taken as the primary endpoint and the roentgenograms and explanted prostheses were analyzed for failure patterns. In the LDH/Durom¯ group a total of 13 (18%) patients required revision (figs. 1) at a median of 35 months (range 6-44). 6 (8%) for periprosthetic fracture. All 6 periprostethic fractures were associated with minimal or no trauma and all had ALVAL identified histologically. To date there have been no failures in the CPT¯/28mm head Allofit¯ group. Several failures demonstrated bone loss in Gruen zones 8 ± 9 ± 10 (fig. 2). We demonstrate an unacceptably high rate of failure in CPT¯ MoM LDH hip replacements, with a high failure secondary to periprosthetic fracture and postulate a mechanism associated with local toxicity to metal ions. We strongly advise against this combination of prosthesis


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_V | Pages 3 - 3
1 Mar 2012
Jenkins PJ Teoh K Simpson PM Dave J Simpson A Breusch S
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Clostridium difficile is associated with a range of gastrointestinal disorders ranging from diarrhoea to toxic megacolon. Alteration of the normal gut flora by antibiotics is a key predisposing factor. Although antibiotic prophylaxis is routinely administered during joint replacement surgery, there has been controversy about both type and duration of prophylaxis. The primary aim of this study was to determine the incidence of C. diff associated disease (CDAD) following hip and knee replacement and to investigate potential risk factors. A laboratory database was interrogated to identify patients developing CDAD after hip or knee replacement from January 2006 to December 2008. A database of arthroplasty patients was used to identify a control group of patients without CDAD to compare the effects of prescription of antibiotics for reasons other prophylaxis of deep infection, comorbidity and the use of gastroprotective agents. Eight patients developed CDAD. There were 1.7 cases of CDAD per 1000 joint replacements. Patients developing CDAD were more likely to have been prescribed additional antibiotics (p=0.047). There were no differences in the use of gastroprotective agents (p=0.703). A trial of a new prophylaxis regime would require 43,198 patients in each arm to show a reduction to 1 case per 1000 procedures. Cefuroxime based antibiotic prophylaxis is safe in patients undergoing elective joint replacement. Extremely large studies would be required to show marginal clinical benefits of new regimes. One prophylaxis policy will not suit all orthopaedic patient groups or procedures


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 185 - 185
1 Sep 2012
Von Knoch F Neuerburg C Impellizzeri F Goldhahn J Frey P Naal F Von Knoch M Leunig M
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Background. Second-generation high-carbon CoCrMo-alloy metal-on-metal total hip arthroplasty (THA) was introduced in the late 1980s following reports of early loosening, impingement, pronounced wear, and hypersensitivity in the first-generation metal-on-metal articulations. There has been inconsistent data that specifically addresses the clinical performance and longevity of second-generation metal-on-metal THA. The purpose of this study was to evaluate the survival of second-generation metal-on-metal primary THA and to assess the influence of demographic factors on implant survival in a large patient cohort. Methods. One thousand two hundred and seventy second-generation 28 mm metal-on-metal primary THA in 1121 patients were performed at one institution from 1994 to 2004. According to the International Documentation and Evaluation System patients were followed routinely at one year, two years and every five years thereafter. Clinical and radiographic outcome data was prospectively recorded using a hospital joint registry. At a mean follow-up of 6.8 years postoperatively, the probability of survival of THA was estimated using the method of Kaplan and Meier. Relative risk factors for implant failure that included age, gender, BMI, type of implant fixation and size of implant components were calculated using the Cox proportional-hazards model. Results. Sixty three (5%) hips were revised because of aseptic loosening (28 hips), infection (8 hips), periprosthetic fracture (8 hips), recurrent dislocation (8 hips), pain without implant loosening (7 hips) and breakage of the cup (4 hips). The probability of survival at ten years, with revision for any reason as the endpoint, for the THA as a whole was 0.90 (95% confidence interval, 0.87 to 0.94). The probability of survival for the cup was 0.90 (95% confidence interval, 0.86 to 0.93) and for the stem 0.94 (95% confidence interval, 0.91 to 0.97). No demographic factors or covariates were found to significantly affect survivorship. Conclusion. Second-generation metal-on-metal primary THA did not demonstrate a superior probability of survival at ten years compared with previous reports on other weight-bearing surfaces. Based on these findings and with consideration of concerns that relate to putative local and systemic toxicity of metal debris, the use of second-generation metal-on-metal articulations for primary THA remains moot


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 341 - 341
1 Sep 2012
Bernstein M Desy N Huk O Zukor D Petit A Antoniou J
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Introduction. Metal-on-metal (MoM) articulations in total hip replacement (THR) have become an attractive option for young, active patients. Short-term reports have demonstrated elevated systemic metal ion levels in the blood and urine. Disseminated concentrations of cobalt and chromium have raised concern regarding cellular toxicity, chromosomal damage and adverse local soft tissue reactions. Long-term studies are required to support the increased use of MoM bearings in younger patients given their potential deleterious effects. The purpose of the current study was to report the 7–13 year clinical, radiographic, and metal ion results in patients following MoM THR. Methods. We prospectively followed 165 patients (196 hips) after second-generation MoM THR between July 1997 and November 2003. Functional outcome was measured using the Harris Hip Score (HHS) and the University of California Los Angeles (UCLA) Activity Score. Radiographic analysis was performed using Einzel-Bild-Roentgen-Analyse (EBRA) by two of the authors blinded to the study. Cobalt and chromium metal ions were measured from whole blood and analyzed using inductively coupled plasma-mass spectrometry. Results. 163 prostheses were analyzed. The mean age at surgery was 50.8 years (range, 17 to 66). There were 80 females and 83 males. The mean follow-up was 8.87 years (range, 7–13 years). Four hips (2.5%) were revised: 2 for infection at 0.2 and 7 years; 1 for a loose stem at 1.3 years; and 1 for a loose cup at 9 years. One patient received wound debridement for a superficial infection and did not have any components revised. The mean HHS and UCLA scores at the last follow-up were 91 and 6.8, respectively. The mean acetabular inclination and anteversion was 40 degrees (range, 24 to 57), and 19 degrees (range, 3 to 39), respectively. Median cobalt levels peaked at a value of 2.87 μg/L at 4 years (p<0.0001 vs. pre-operative) and subsequently decreased to 2.0 μg/L after 9 years (p=0.002 vs. 4-years). Median chromium levels maximally increased up to 0.75 μg/L after 5 years (p<0.0001 vs. pre-operative) and tended to decrease thereafter to values of 0.56 μg/L after 7 years. The Kaplan-Meier survivorship was 91.3% for revision for all causes, and 97.5% when excluding the hips revised for a manufacturer's defect at a mean of 8.87 years (range, 7–13 years). Conclusion. The present 7–13 years follow-up study of MoM THRs indicates that the clinical and radiological results are satisfactory with low revision rates. Furthermore, our study demonstrates the trend of metal ion levels in whole blood over a long-term. Both cobalt and chromium ion levels peaked at 4 and 5 years, respectively, and gradually decreased thereafter


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 746 - 754
1 Apr 2021
Schnetzke M El Barbari J Schüler S Swartman B Keil H Vetter S Gruetzner PA Franke J

Aims

Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation.

Methods

A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days).


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 442 - 448
1 Mar 2021
Nikolaou VS Masouros P Floros T Chronopoulos E Skertsou M Babis GC

Aims

The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip.

Methods

In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims

Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture.

Methods

The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.


Bone & Joint Research
Vol. 5, Issue 9 | Pages 427 - 435
1 Sep 2016
Stravinskas M Horstmann P Ferguson J Hettwer W Nilsson M Tarasevicius S Petersen MM McNally MA Lidgren L

Objectives

Deep bone and joint infections (DBJI) are directly intertwined with health, demographic change towards an elderly population, and wellbeing.

The elderly human population is more prone to acquire infections, and the consequences such as pain, reduced quality of life, morbidity, absence from work and premature retirement due to disability place significant burdens on already strained healthcare systems and societal budgets.

DBJIs are less responsive to systemic antibiotics because of poor vascular perfusion in necrotic bone, large bone defects and persistent biofilm-based infection. Emerging bacterial resistance poses a major threat and new innovative treatment modalities are urgently needed to curb its current trajectory.

Materials and Methods

We present a new biphasic ceramic bone substitute consisting of hydroxyapatite and calcium sulphate for local antibiotic delivery in combination with bone regeneration. Gentamicin release was measured in four setups: 1) in vitro elution in Ringer’s solution; 2) local elution in patients treated for trochanteric hip fractures or uncemented hip revisions; 3) local elution in patients treated with a bone tumour resection; and 4) local elution in patients treated surgically for chronic corticomedullary osteomyelitis.