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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).


Bone & Joint Research
Vol. 7, Issue 10 | Pages 570 - 579
1 Oct 2018
Kallala R Harris WE Ibrahim M Dipane M McPherson E

Aims. Calcium sulphate has traditionally been used as a filler of dead space arising during surgery. Various complications have been described following the use of Stimulan bio-absorbable calcium sulphate beads. This study is a prospective observational study to assess the safety profile of these beads when used in revision arthroplasty, comparing the complication rates with those reported in the literature. Methods. A total of 755 patients who underwent 456 revision total knee arthroplasties (TKA) and 299 revision total hip arthroplasties (THA), with a mean follow-up of 35 months (0 to 78) were included in the study. Results. A total of 32 patients (4.2%) had wound drainage, and this was higher with higher bead volumes and in McPherson grade C patients. There was also a significantly higher bead volume in the 41 patients who developed hypercalcaemia, two of which were symptomatic (p < 0.0001). A total of 13 patients (1.7%) had heterotopic ossification (HO). There was no statistically significant relationship between the development of HO and bead volume (p > 0.05). Conclusion. The strength of this study lies in the large number of patients and the detailed data collection, making it the most comprehensive report available in the literature on the use of calcium sulphate-based bone substitutes. Cite this article: R. Kallala, W. Edwin Harris, M. Ibrahim, M. Dipane, E. McPherson. Use of Stimulan absorbable calcium sulphate beads in revision lower limb arthroplasty: Safety profile and complication rates. Bone Joint Res 2018;7:570–579. DOI: 10.1302/2046-3758.710.BJR-2017-0319.R1


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_5 | Pages 9 - 9
1 May 2015
Chaturvedi A Barlow G Sharma HK
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Background:. – A multidisciplinary approach is essential to treat chronic osteomyelitis. Surgical debridement of macroscopic infection precedes targeted antibiotics to eradicate microscopic infection. This study analyses early results of our single-stage protocol for chronic osteomyelitis using antibiotic-impregnated calcium sulphate beads (Stimulan). Methods:. – We retrospectively analysed patients with primary or secondary chronic osteomyelitis treated with Stimulan. Patients with incomplete metal-work removal or follow up less than 3 months were excluded. Our study focused on 15 patients (10 male) with an average age of 40.5 years (16–73 years), average follow up of 10.6 months (3 – 21 months). There were 12 cases of secondary osteomyelitis (3 primary). Majority of cases involved the tibia, femur or humerus. Following debridement Stimulan mixed with Vancomycin and/or tobramycin was placed to obliterate dead space and deliver local antibiotics. Intravenous antibiotics, typically piperacillin/tazobactam and/or teicoplanin, were administered post-operatively until tissue culture results were known – rationalised long term antibiotic regimen followed thereafter. Results:. – Staphylococcus aureus was the commonest organism. Follow up monitoring indicated absorption of Stimulan typically by 3 months and no evidence of recurrence based on clinical, radiographic and biochemical parameters. Conclusion:. – Single stage osteomyelitis treatment with Stimulan shows early promising results, is cost effective and decreases the morbidity of further surgery


Background. Diabetes is bad, common and diabetic foot ulcers (DFU) once established lead to high rates of amputation. In Nottingham our standard management for infected diabetic foot ulcers is surgical debridement, microbiological sampling, packing with gentamicin beads and targeted antibiotic therapy. Recently we have switched to packing with Stimulan, which is a purified synthetic calcium sulphate compound that can be mixed with patient appropriate antibiotics, is biodegradable and delivers better elution characteristics compared to gentamicin beads. Aim. To assess the efficacy of Stimulan compared to Gentamicin beads in the surgical management of infected diabetic foot ulcers. Methods. In 2012/13 the department audited its results of DFU surgical management with gentamicin beads. In 2014/5 the audit was repeated but Stimulan was used instead due to the perceived advantages Patients with infected DFU that could comply with treatment were included. Patients who had other sources of sepsis, non-compliant or moribund were excluded. Treatment pathways were identical apart for the use of Stimulan in 2014/5. The primary outcome measure was ulcer healing. The secondary outcome measure was length of stay and recurrence. Results. Each group had 23 patients. The gentamicin group had a DFU for 12.3 months(3weeks-5 years) before presentation for surgery compared to the Stimulan group 6.1 months(2weeks-5years). Both groups had failed non-surgical management. The majority of the ulcers were located on the forefoot. In the stimulan group 70% (16/23) of ulcers had healed with an average of 4 months(2–7 months) compared to 57% (13/23) in the Gentamicin group within 6months(1–12). The length of stay was shorter in the Stimulan group 7 days (1–70) compared to 28days(1–70) in the Gentamicin group. Conclusion. In our review Stimulan was superior to Gentamicin beads in the management of infected diabetic foot ulcers. We believe it has a role to play in limb salvage


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 29 - 29
1 Dec 2020
Thahir A Lim JA West C Krkovic M
Full Access

Intro

Calcium sulphate (CS) is a recent alternative for antibiotic elution in infected bones and joints. The purpose of this study is to evaluate the use of antibiotic impregnated calcium sulphate (AICS) beads in the management of infected tibia and femur, with regards to patient outcomes and complication rates (including reinfection rate, remission rate and union rate).

Methods

Searches of AMED, CINAHL, EMBASE, EMCARE, Medline, PubMed and Google Scholar were conducted in June 2020, with the mesh terms: “Calcium sulphate beads” or “Calcium sulfate beads” or “antibiotic beads” or “Stimulan” AND “Bone infection” or “Osteomyelitis” or “Debridement” AND “Tibia” or “Femur”. Risk of bias was assessed using the Risk of Bias in Non-randomised Studies of interventions (ROBINS-i) tool, and quality assessed via the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_17 | Pages 54 - 54
1 Dec 2018
Sandiford N Pierce R Dabis J Mitchell P Trompeter A Jonathan H
Full Access

Aim. Antibiotic-eluting calcium compounds can be used to deliver antibiotics in the management of prosthetic joint infection (PJI). Described omplications include wound drainage, heterotopic ossification(HO) as well as hypercalcaemia which is potentially life threatening. The aim of this study is to assess the incidence of hypercalcaemia and other complications between two calcium based antibiotic delivery systems. Method. A retrospective study was performed. Thirty two patients treated with Stimulan or Cerament Calcium based antibiotic delivery system between August 2014 to January 2017 were included. Seven patients received Cerament, 21 cases received Stimulan and one patient received both. The volume used as well as pre- and post-operative serum calcium were recorded as well as any wound related complications and radiologic changes suggestive of heterotopic ossification. The postoperative serum adjusted Calcium were taken weekly during the initial post operative period. Patients with overactive parathyroid disease and pre-existing renal disease were excluded. Results. Stimulan group (n=22, Mean volume 39.2ml). Mean pre-operative serum calcium was 2.48mmol/l. At 1 and 2 weeks post-surgery mean levels were 2.51 and 2.47mmol/l (patients receiving <40ml), and 2.47 and 2.50mmol/l (patients receiving >40ml – 9 cases) respectively. There was no significant difference between pre/post-operative levels at 1 (p=0.97) or 2 weeks (p=0.91) and no difference between those treated with <40ml or >40ml of Stimulan at 1 or 2 weeks (p=0.91). Cerament group (n=8, Mean volume 9.4ml). Mean pre-operative serum calcium was 2.42mmol/l. Mean post-operative levels at 1 and 2 weeks post-surgery were 2.44mmol/l (p=0.92) and 2.37mmol/l (p=0.61) respectively. One patient had prolonged wound discharge and required re operation. No HO was encountered. Conclusions. Our results suggest that hypercalcaemia and other complications are uncommon with the use calcium based antibiotic delivery systems and that calcium based antibiotic delivery systems are safe in the treatment of PJI


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 99 - 99
1 Jan 2016
Cowie R Carbone S Aiken S Cooper J Fisher J Jennings L
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Introduction. When third body particles originating from bone cement or bone void fillers become trapped between articulating surfaces of joint replacements, contact surfaces may be damaged leading to accelerated wear and premature failure of the implant. In this study, the damage to cobalt chrome counterfaces by third body particles from PMMA bone cement (GMV, DePuy) and various bone void fillers was investigated; then wear tests of UHMWPE were carried out against these surfaces. Methods. Third body particles of polymerised GMV bone cement and the bone void fillers; OsteoSet (with tobramycin), Stimulan and Stimulan+ (with vancomycin and tobramycin) (provided by Biocomposites Ltd.) were trapped between an UHMWPE pin and a highly polished cobalt chrome plate. A load of 120N was applied to the pin and using an Instron materials testing machine, the plate was pulled beneath the pin to recreate third body damage [1]. The resulting surface topography of the plate was analysed using white light interferometry (Bruker NPFLEX). Pin on plate wear tests of GUR 1020 UHMWPE pins were carried out against the plates perpendicular to the direction of damage for 500,000 cycles in 25% bovine serum using a 6-station multi-axial reciprocating rig under conditions to replicate the kinematics in total knee replacement. Wear of the pins was determined by gravimetric analysis and results were compared to negative (highly polished) control plates and positive controls scratched with a diamond stylus (lip height 2µm). Statistical analysis was carried out using one-way ANOVA with significance taken at p<0.05. Results. Following damage simulation with Stimulan and Stimulan+, no scratches could be seen on the surface of the cobalt chrome plates using a stereomicroscope under 63× magnification (Figure 1). Table 1 shows that OsteoSet caused surface damage with the highest density of scratches, which had a greater mean lip height than those caused by the other third body materials. Stimulan+ caused significantly (p=0.002) fewer scratches than Osteoset and the surface damage caused by Stimulan was below the resolution of the surface analysis measurement technique used. The pin on plate wear test showed that under the test conditions used, the wear of UHMWPE was similar (p=0.108) for negative control plates and plates scratched with third body particles and a significant (p<0.001) increase in wear was only observed against the positive control plates [2]. Discussion. This study shows that third body particles originating from bone cement and bone void fillers can damage the surface of highly polished cobalt chrome plates and that materials of similar composition can cause varying severity of damage. Wear tests against plates damaged with third body particles did not significantly affect the wear of UHMWPE and to significantly increase wear, scratches needed to have a lip height of 2µm or above


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 62 - 62
1 Apr 2018
Soufi M Haque S Jayaraman S Faris B Shoaib A
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Aim. To determine if systemic toxicity occurs after the use of antibiotic loaded calcium sulphate in the treatment (1) of bone and soft tissue infection. Although antibiotic loaded calcium sulphate is increasingly used for the local treatment of bone and soft tissue infection, 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. Methods. Patients with osteomyelitis or soft tissue infection underwent surgical debridement and lavage of the infected tissue in routine fashion. Patients with osteomyelitis were graded with the Cierny-Mader classification. Bone cavities and soft tissue dead spaces were packed with antibiotic loaded calcium sulphate (10–40 cc) loaded with Vancomycin (1–4 g) and Gentamicin (240–960 mg). The wounds were closed over the antibiotic loaded calcium sulphate. Patients underwent serial assays of Vancomycin and Gentamicin levels on the day of surgery and the first two post-operative days. Renal function was also measured. Results. 12 limbs in 10 patients were treated for osteomyelitis or soft tissue infection. There was 1 Cierny-Mader grade 1, 3 Cierny-Mader grade 3, and 2 Cierny-Mader grade 4. Two had deep soft tissue infection alone. There were 3 type A hosts and 7 type B hosts. The patients age ranged from 24 to 89 (mean 54). In patients without renal dysfunction, the systemic levels were either unmeasurable at the first assay, or below the acceptable trough level. (Mean 2.4 and 1.8 for Vancomycin and Gentamycin respectively). They had unmeasurable 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 Stimulan, antibiotic assays are not necessary in patients who have normal renal function, as they clear the systemic absorption as quickly as it is generated. Patients with impaired renal function should have lower doses of antibiotic used for their topically applied carrier, and should undergo assays regularly to ascertain if levels are remaining below the accepted range determined for systemically administered antibiotics. If they remain high, the antibiotic loaded calcium sulphate could be removed. * Stimulan (Biocomposites, Keele, UK)


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_10 | Pages 31 - 31
1 Aug 2021
Ahmed B George D El Ashmawy A Minhas Z Palmer A Taylor A Kendrick B
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Treatment of periprosthetic joint infection (PJI) can include local delivery of antibiotics. A frequently used medium is absorbable calcium sulphate beads. The aims of this study were to:. identify how often organisms in infected THRs are sensitive to the added antibiotics. establish the incidence of persistent wound discharge and hypercalcaemia. All patients who received an antibiotic loaded calcium sulphate carrier (Stimulan, Biocomposites, Keele, UK) for either confirmed infection, presumed infection or for prophylaxis between July 2015 and July 2020 were included. Stimulan use was at the discretion of the surgeon, and between 10 and 40cc was used. In the absence of a known organism we routinely used 1g vancomycin and 240mg gentamicin per 10 cc of calcium sulphate. Post-operative sensitivities for all organisms cultured were compared to the antibiotics delivered locally. Persistent wound drainage was defined as discharge beyond the third postoperative day. Patients had serum calcium measured if they developed symptoms consistent with hypercalcaemia (Ca >2.6 mmol/L) or the clinical team felt they were at high risk. 189 patients (mean age 66.9 years, mean BMI 28.9, 85 male, 104 female) were included. 11 patients had a native joint septic arthritis, 42 presented with acute PJI and 136 presented with chronic PJI. 133 patients grew an organism, of which 126 were sensitive to the added antibiotics. Of the seven patients with resistant growth five had vancomycin-resistent Enterococcus, one Pseudomonas and one multi-organism growth including coagulase negative Staphylococcus. 40 patients experienced persistent wound discharge, with eight requiring re-operation. All other cases settled with dressing management. 12 patients developed hypercalcaemia (3/64 10cc, 7/117 20cc, 0/2 30cc and 2/6 40cc). The peak calcium reading ranged between the second and twelfth post-operative day. The addition of vancomycin and gentamicin to absorbable calcium sulphate covers the majority of organisms found in culture positive infection in our cohort. It also appears safe, with an acceptable incidence of hypercalcaemia or wound discharge. Further work is required to identify patients at greatest risk of culturing resistant organisms or delayed wound healing


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_6 | Pages 34 - 34
1 May 2021
Katsura C Bates J Barlow G Chuo CB
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Introduction. Osteomyelitis (OM) is a challenging condition to diagnose and treat. The multidisciplinary team (MDT) approach is used in managing complex diseases such as cancer and diabetes. The Hull Regional Bone Infection MDT team was established to provide coordinated care for patients suspected to have OM. This study reviews the orthoplastic treatment and outcomes of patients with non-periprosthetic OM. Materials and Methods. Retrospective review of patients presenting to the MDT team who had orthoplastic intervention with debridement and flap coverage between 1/6/2014 - 30/11/2018. We describe our MDT approach of assessment, planning for surgical intervention and antibiotic protocol. Data was obtained from electronic and paper patient records, and PACS. Results. Twenty-nine patients were identified (75.9% male). Mean age was 52.7 (23–82). Median duration of symptoms at surgery was 10 months (IQR 4.0–34.3). Cierny-Mader (CM) Host Type B. (L). (41.4%), type B. (S). (34.5%), and type B. (S+L). (17.2%). Twenty-four patients (82.8%) were CM anatomical class IV. Twenty-four patients (82.8%) had single-stage surgical treatment. Twenty-one patients received 23 free flaps. Anterolateral thigh flap (9/23) and gracilis muscle flap (7/23) were most commonly used. Tibialis anterior flap was the most commonly used local flap. Stimulan was used in 65.5%. Staphylococcus aureus was seen in 60% of patients. Mean follow-up time was 21 months (1–62). There were 2 (6.9%) OM recurrence. Both patients were CM anatomical class IV. Conclusions. Our study showed that our MDT management of patients with OM can achieve a low recurrence rate despite a high proportion of patients with severe OM. We recommend considering an MDT approach for these complex OM patients


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_16 | Pages 117 - 117
1 Dec 2015
Nayar D Hornsby J Aldridge C Scott S Longstaff L Jennings A Shaw N Duffy P
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Bone and joint infections of the lower limbs cause significant morbidity for patients. Infection is a devastating complication for prosthetic joint replacements. In this large case series from a single centre in the NE of England, we present our experience of using antibiotic impregnated dissolvable synthetic pure calcium sulphate beads [Stimulan R]1 for local elution of antibiotics at the site of infection. At our centre, from August 2012 to Jan 2015, antibiotic impregnated dissolvable synthetic pure calcium sulphate beads [Stimulan R]1 was used for local elution of antibiotics in 45 patients with lower limb bone or joint infections. Tailored plans were made by Orthopedic surgeon and Microbiologist MDTs based on bacteria and sensitivities. Cases included 20 THR, 13 TKR, 5 Hemiarthroplasties, 4 tibial nonunions, 1 infected femoral plate and 2 paediatric osteomyelitis. Organisms isolated – Coagulase negative Staphs, Staph aureus, MRSA, E coli, Enterococcus, Enterobacter cloacae, Serratia and 1 Salmonella typhimurium!!. In our cases, a combination of Vancomycin and Gentamicin was added to Stimulan beads following manufacturer's mixing guide. In 2 cases, we added Ceftazidime to the beads and Daptomycin in 1 case. In bone infections, surgical debridement and systemic antibiotics were also needed. All arthroplasty infections underwent explantation with addition of antibiotic impregnated beads either at single stage or both stages of 2 stage revisions and systemic antibiotics. Follow up (ranging 9months to 2 years) indicates no failure so far. The beads caused no excessive wound drainage. There was no need to remove beads as they dissolve. In the cases where a staged revision was performed, the beads were inserted at first stage and there was microbiological clearance of infection at 2nd stage. Our series includes some experince in paediatric cases too. As far as we are aware, this is the largest series in the UK from a single centre reporting experience with Stimulan in infected bone and joints of the lower limbs. Our experience suggests use of dissolvable pure Calcium sulphate beads impregnated with carefully selected antibiotics, works as an effective adjunct to current treatments and offers flexibility with choice of antiobiotics that can be added locally. Acknowledgements. Biocomposites UK for supporting attendance at EBJIS. Authors control ownership of all data and analysis


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 111 - 111
1 Dec 2020
Lim JA Thahir A Krkovic M
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Introduction. The BOAST (British Orthopaedic Association Standards for Trauma) guidelines do advise that open pilon fractures amongst other open lower limb fractures need to be treated at a specialist centre with Orthoplastic care. The purpose of this study was to determine clinical outcomes in patients with open pilon fractures treated as per BOAST guidelines including relatively aggressive bone debridement. Methods. A retrospective analysis of a single surgeon series of open pilon fractures treated between 2014 and 2019 was conducted. Injuries were graded according to the Gustillo-Anderson classification and all patients were included for the assessment of the rate of infection and fracture healing. Functional outcome assessment was performed in all patients according to the American Orthopedic Foot and Ankle Score (AOFAS) at 6 months after definitive surgery. Initial wound with bone debridement and application of a spanning external fixator was performed within an average of 13.5 (Range: 3–24) hours. Fixation with FWF (Fine Wire Frame) was performed when the wound was healed, with the mean time from primary surgery to application of FWF being 24.5 (Range: 7–60) days. Results. There was a total of 20 patients including 16 males and 4 females. The mean age was 50.45 (Range: 16–88) years. Follow-up was for an average of 23.2 (Range: 5–51) months. There were 3 patients with Gustilo Type I injuries, 6 with Type II, 4 Type with type IIIa and 7 with Type IIIb injuries. Average time to bone union was 9.3 (Range: 2–18) months. The mean AOFAS score was 66 (Range: 15–97) points. TSF was used on 18 patients, while 2 patients had an Ilizarov frame. A corticotomy was performed on 4 patients with critical bone defect post debridement, while 2 patients had Stimulan beads with antibiotics. There was 1 case (5%) of deep infection and 9 cases (45%) of superficial infection. There were also 2 cases (10%) of non-union which required bone grafting from their femur using a RIA (Reamer Irrigation Aspirator). Other complications included 1 case of acute compartment syndrome, 1 case of pulmonary embolism, 1 case of necrotic skin and 1 case of amputation. Conclusion. Results of our study suggests that the use of staged wound debridement including relatively aggressive bone debridement in conjunction with antibiotics, external fixators and patient tailored conversion from spanning external fixator to fine wire frame achieves low rates of wound infection and complications for patients with open pilon fractures


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 48 - 48
1 May 2017
Cooper J McKinnon J Walsh W Oliver R Rawlinson J Cristou C
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Background. Calcium sulfate and phosphate have a long clinical history of use as bone-void fillers (BVF) with established biocompatibility and resorption profiles. It has been widely reported that the addition of ‘impurity’ elements such as Silicon, Strontium and Zinc to calcium phosphate is advantageous, resulting in an improved bone healing response. Methods. This study examined the in vivo response of two formulations of calcium sulfate, as 3mm diameter hemispherical beads, in critical sized defects created in cancellous bone of distal femur and proximal tibia (10mm diameter × 13mm depth) in adult sheep; beads prepared from recrystallised pharmaceutical grade calcium sulfate (RPCS, Stimulan, Biocomposites Ltd, UK) and a lower purity medical grade material containing 1% strontium (SrCS). The animals were sacrificed at 3, 6 and 12 weeks post implantation and the surgical sites analysed using microCT and decalcified histology. Results. Radiographic analysis showed a slower resorption for SrCS compared to RPCS. Radiographic analysis for both materials confirmed little residual beads at three weeks post implantation. Radiographs at sacrifice confirmed no adverse reactions at any sites at 3, 6 and 12 weeks. Radiographic data alone was not adequate to determine the status of the bone formation and the implant resorption at the implant site. Histological analysis confirmed little or no adverse tissue reactions to either material. However, RPCS outperformed the modified material in terms of new bone formation at all time points post implantation. At 3 weeks histology for RPCS confirmed that residual beads were still visible with active new bone growth appearing to penetrate centripetally into the defect with some resorption of the implant material. By 6 weeks significant new bone was present throughout the defect. In comparison, absorption of the modified material was slower, and penetration of new bone into the defect was less progressed. Conclusions. The rapid bone regenerative ability of the recrystallised pharmaceutical grade calcium sulfate was demonstrated. The presence of 1% Strontium impurity acted to delay implant absorption and bone healing in this model


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 59 - 59
1 Dec 2017
Frapwell C Duignan C Webb J Aiken S Cooper J Stoodley P Howlin R
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Aim. Bacterial biofilms play a key role in prosthetic infection (PI) pathogenesis. Establishment of the biofilm phenotype confers the bacteria with significant tolerance to systemic antibiotics and the host immune system meaning thorough debridement and prosthesis removal often remain the only possible course of treatment. Protection of the prosthesis and dead-space management may be achieved through the use of antibiotic loaded cements and beads to release high concentrations of antibiotics at the surgical site. The antibacterial and antibiofilm efficacy of these materials is poorly understood in the context of mixed species models, such as are often encountered clinically. Methods. A P. aeruginosa and S. aureus in vitro co-culture biofilm model was grown using 1/5th BHI supplemented with 20 µM hemin. The ability of beads made from a synthetic calcium sulfate (CaSO4) loaded with vancomycin, tobramycin and vancomycin & tobramycin in combination to prevent biofilm formation and kill established co-culture biofilms were assessed using viable cell counts and confocal scanning laser microscopy (CSLM) over a 7 day time course. To assay for genetic changes to the individual species as a result of their presence together within a biofilm, mutation rates were measured using fluctuation analysis following growth as planktonic and biofilm cultures, alone or in co-culture. Mutants were determined based on their ability to grow on agar plates containing an inhibitory concentration of rifampicin. Mutation rates were calculated using the Ma-Sandri-Sarkar Maximum Likelihood Estimator and 94% confidence intervals compared for significance. Results. Mixed species biofilms displayed differential sensitivity to vancomycin alone and tobramycin alone CaSO4-loaded beads relative to single species biofilms. Preliminary data suggests 10- and 100-fold increase in mutation rates of P. aeruginosa and S. aureus, respectively, when in a co-culture relative to monospecies biofilm which, while further work is needed, may directly or indirectly contribute to the differing antibiotic sensitivities observed. A broad-spectrum intervention of CaSO4-loaded vancomycin & tobramycin beads was able to prevent bacterial colonisation and attenuate P. aeruginosa and S. aureus mixed species biofilm formation for multiple days. Conclusions. Synthetic antibiotic-loaded CS beads, with a broad-spectrum antibiotic combination, have potential to reduce or eliminate mixed species biofilm formation on implant material by providing locally high concentrations over sufficient time periods to aid in the management of PIs. * Stimulan, Biocomposites Ltd


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 20 - 20
1 Jan 2017
Mohammad H Pillai A
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We describe a case series using calcium sulphate bio composite with antibiotics (Cerament/Stimulan) in treating infected metalwork in the lower limb. Eight patients aged 22–74 (7 males, 1 female) presented with clinical evidence of infected limb metal work from previous orthopaedic surgery. Metal work removal with application of either cerement in 5 cases (10–20ml including 175mg–350mg gentamycin) or stimulan in 3 cases (10–20ml including either 1g vancomycin or clindamycin 1.2g or 100mg tigecycline) into the site was performed. Supplemental systemic antibiotic therapy (oral/intravenous) was instituted based on intraoperative tissue culture and sensitivity. Four patients had infected ankle metalwork, 2 patients infected distal tibial metalwork and 2 had infected external fixators. Metal work was removed in all cases. The mean pre operative CRP was 15.8mg/l (range 1–56mg/l). The mean postoperative CRP at 1 month was 20.5mg/l (range 2–98mg/l). The mean pre op WCC was 7.9×10. 9. (range 4.7–10.5 ×10. 9. ). Mean post op WCC at 1 month was 7.1×10. 9. (range 5.0–9.2×10. 9. ). The organisms cultured included enterobacter, staphylococcus aureus, staphylococcus epidermidis, staphylococcus cohnii, stenotrophomonas, acinetobacter, group B streptococcus, enterococcus and escherichia coli. No additional procedures were required in any case. All surgical wounds went on to heal uneventfully. Infection control and union was achieved both clinically and radiologically in all cases. Our results support the use of a calcium sulphate bio composite with antibiotic as an adjuvant for effective local infection control in cases with implant related bone sepsis. The technique is well tolerated with no systemic or local side effects. We believe that implant removal, debridement and local antibiotic delivery can minimise the need for prolonged systemic antibiotic therapy in such cases


Bone & Joint Open
Vol. 4, Issue 8 | Pages 643 - 651
24 Aug 2023
Langit MB Tay KS Al-Omar HK Barlow G Bates J Chuo CB Muir R Sharma H

Aims

The standard of wide tumour-like resection for chronic osteomyelitis (COM) has been challenged recently by adequate debridement. This paper reviews the evolution of surgical debridement for long bone COM, and presents the outcome of adequate debridement in a tertiary bone infection unit.

Methods

We analyzed the retrospective record review from 2014 to 2020 of patients with long bone COM. All were managed by multidisciplinary infection team (MDT) protocol. Adequate debridement was employed for all cases, and no case of wide resection was included.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_19 | Pages 6 - 6
1 Nov 2016
Mohammad H Tabain T Pillai A
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Aim. We describe a case series using adjuvant calcium sulphate bio composites with antibiotics in treating infected metalwork in the foot and ankle. Method. 11 patients aged 22–81 (9 males, 2 females) were treated with clinical evidence of infected limb metal work from previous orthopaedic surgery. Metal work removal with intra osseous application of either cerement in 8 cases (10–20ml including 175mg–350mg gentamycin) or stimulan in 3 cases (5–12ml including 1g vancomycin) into the site was performed. Supplemental systemic antibiotic therapy (oral/intravenous) was instituted based on intraoperative tissue culture and sensitivity. Results. 7 patients had infected ankle metalwork, 2 had infected foot metalwork and 2 had infected external fixators. Metal work was removed in all cases. Mean pre operative CRP was 25.4 mg/l (range 1–137mg/l). Mean postoperative CRP at 1 week was 15.4mg/l (range 2–36mg/l) and at 1 month was 16.1mg/l (range 2–63mg/l). Mean pre op WCC was 8.5×10. 9. (range 6.2–10.6×10. 9. ). Mean post op WCC at 1 week was 8.8×10. 9. (range 5.1–12.7×10. 9. ) and 1 month was 7.1×10. 9. (range 3.7–10.4×10. 9. ). Organisms cultured included enterobacter, staphylococcus species, stenotrophomonas, acinetobacter, group B streptococcus, enterococcus, escherichia coli, pseudomonas, morganella morganii and finegoldia magna. Infection eradication as a single stage procedure with primary would closure and healing was achieved in 10 out of 11 cases (90.9%). No additional procedures were required in these cases. Conclusions. Our results support the use of a calcium sulphate bio composite with antibiotic as an adjuvant for effective local infection control in cases with implant related bone sepsis. The technique is well tolerated with no systemic or local side effects. Our results show that a single stage implant removal, debridement and local antibiotic delivery can achieve over 90% success rates. We theorise that it could minimise the need for prolonged systemic antibiotic therapy in such cases


Bone & Joint Open
Vol. 3, Issue 12 | Pages 991 - 997
23 Dec 2022
McPherson EJ Stavrakis AI Chowdhry M Curtin NL Dipane MV Crawford BM

Aims

Large acetabular bone defects encountered in revision total hip arthroplasty (THA) are challenging to restore. Metal constructs for structural support are combined with bone graft materials for restoration. Autograft is restricted due to limited volume, and allogenic grafts have downsides including cost, availability, and operative processing. Bone graft substitutes (BGS) are an attractive alternative if they can demonstrate positive remodelling. One potential product is a biphasic injectable mixture (Cerament) that combines a fast-resorbing material (calcium sulphate) with the highly osteoconductive material hydroxyapatite. This study reviews the application of this biomaterial in large acetabular defects.

Methods

We performed a retrospective review at a single institution of patients undergoing revision THA by a single surgeon. We identified 49 consecutive patients with large acetabular defects where the biphasic BGS was applied, with no other products added to the BGS. After placement of metallic acetabular implants, the BGS was injected into the remaining bone defects surrounding the new implants. Patients were followed and monitored for functional outcome scores, implant fixation, radiological graft site remodelling, and revision failures.


Bone & Joint Research
Vol. 11, Issue 11 | Pages 835 - 842
17 Nov 2022
Wiesli MG Livio F Achermann Y Gautier E Wahl P

Aims

There is a considerable challenge in treating bone infections and orthopaedic device-associated infection (ODAI), partly due to impaired penetration of systemically administrated antibiotics at the site of infection. This may be circumvented by local drug administration. Knowledge of the release kinetics from any carrier material is essential for proper application. Ceftriaxone shows a particular constant release from calcium sulphate (CaSO4) in vitro, and is particularly effective against streptococci and a large portion of Gram-negative bacteria. We present the clinical release kinetics of ceftriaxone-loaded CaSO4 applied locally to treat ODAI.

Methods

A total of 30 operations with ceftriaxone-loaded CaSO4 had been performed in 28 patients. Ceftriaxone was applied as a single local antibiotic in 21 operations and combined with vancomycin in eight operations, and in an additional operation with vancomycin and amphotericin B. Sampling of wound fluid was performed from drains or aspirations. Ceftriaxone concentrations were measured by liquid chromatography with tandem mass spectrometry (LC-MS/MS).


Bone & Joint 360
Vol. 5, Issue 3 | Pages 2 - 6
1 Jun 2016
Raglan M Scammell B