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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 111 - 111
1 Apr 2019
Beamish RE Ayre WN Evans S
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Objectives. Investigate the incorporation of an antibiotic in bone cement using liposomes (a drug delivery system) with the potential to promote osseointegration at the bone cement interface whilst maintaining antibiotic elution, anti-microbiological efficacy and cement mechanical properties. Prosthetic joint infection and aseptic loosening are associated with significant morbidity. Antibiotic loaded bone cement is commonly used and successfully reduces infection rates; however, there is increasing resistance to the commonly used gentamicin. Previous studies have shown gentamicin incorporated into bone cement using liposomes can maintain the cement's mechanical properties and improve antibiotic elution. The phospholipid phosphatidyl-l-serine has been postulated to encourage surface osteoblast attachment and in a liposome could improve osseointegration, thereby reducing aseptic loosening. Preliminary clinical isolate testing showed excellent antimicrobial action with amoxicillin therefore the study aims were to test amoxicillin incorporated into bone cement using liposomes containing phosphatidyl-l-serine in terms of antibiotic elution, microbiological profile and mechanical properties. Methods. Amoxicillin was encapsulated within 100nm liposomes containing phosphatidyl-L-serine and added to PMMA bone cement (Palacos R (Heraeus Medical, Newbury, UK)). Mechanical testing was performed according to Acrylic Cement standards (ISO BS 5833:2002). Elution testing was carried out along with microbiological testing utilising clinical isolates. Results. Liposomal encapsulated amoxicillin PMMA bone cement exceeded minimum ISO BS 5833:2002 standards, had better elution at 12.9% when compared with plain amoxicillin (p=0.036 at 48 hours) or commercial gentamicin cement (Palacos R+G, Heraeus Medical, Newbury, UK – previous studies showed 6% elution over the same time period). Amoxicillin showed superior antimicrobial action when compared with gentamicin of the same concentration. However, liposomal encapsulated amoxicillin in solution and liposomal encapsulated amoxicillin in PMMA were both less effective than free amoxicillin in bacterial growth inhibition. The liposomal amoxicillin also seemed to decrease the cement setting time. Conclusions. Phosphatidyl-l-serine containing liposomes maintained the cement's mechanical properties and seemed to have better antibiotic elution, however, had less effective antibacterial action than plain amoxicillin. This difference in antibacterial action requires further investigation along with investigation of osteoblast attachment to phosphatidyl-l-serine containing liposomes within cement. Plain amoxicillin, for those not penicillin allergic, seems to be a credible alternative to gentamicin for incorporation in PMMA bone cement. It has shown superior antibacterial action, which may improve infection rates, whilst maintaining the cement's mechanical properties


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 67 - 67
1 Feb 2020
Gascoyne T Rodgers L Kubiak S Petrak M
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Background. Additive manufacturing (AM) has created many new avenues for material and manufacturing innovation. In orthopaedics, metal additive manufacturing is now widely used for production of joint replacements, spinal fusion devices, and cranial maxillofacial reconstruction. Plastic additive manufacturing on the other hand, has mostly been utilized for pre-surgical planning models and surgical cutting guides. The addition of pharmaceuticals to additively manufactured plastics is novel, particularly when done at the raw material level. The purpose of this study was to prove the concept of antibiotic elution from additively manufactured polymeric articles and demonstrate feasibility of application in orthopaedics. Methods. Using patented processes, three heat-stable antibiotics commonly used in orthopaedics were combined with six biocompatible polymers (2 bioresorbable) into filament and powder base materials for fused deposition modeling (FDM) and selective laser sintering (SLS) AM processes. Raw materials of 1%, 2%, and 5% antibiotic concentrations (by mass) were produced as well as a blend of all three antibiotics each at 1% concentration. Thin disks of 25 mm diameter were manufactured of each polymer with each antibiotic at all concentrations. Disks were applied to the center of circular petri dishes inoculated with a bacterium as per a standard zone of inhibition, or Kirby-Bauer disk diffusion tests. After 72 hours incubation, the zone of inhibited bacterial growth was measured. Periprosthetic joint infection (PJI) of the knee was selected as the proof-of-concept application in orthopaedics. A series of tibial inserts mimicking those of a common TKR system were manufactured via SLS using a bioresorbable base material (Figure 1). Three prototype inserts were tested on a knee wear simulator for 333,000 cycles following ISO 14242–1:2014 to approximate 2–4 months of in vivo use between surgeries of a 2-stage procedure for PJI. Gravimetric measurement and visual damage assessment was performed. Results. Bacterial growth was inhibited to a mean diameter of 32.3 mm (FDM) and 42.2 mm (SLS) for nearly all combinations of polymers and concentrations of antibiotics. Prototype tibial inserts experienced an average of 200 mg of wear during testing and demonstrated no evidence of cracking, delamination or significant deformation (Figure 2). Conclusion. Bench-level testing of these novel antibiotic-eluting polymers demonstrates feasibility for their application in orthopaedic medicine. In particular, treatment of stubborn PJI with potential for increased and sustained antibiotic elution, patient-specific cocktailing, and maintenance of knee joint structure and function compared to existing PJI products and practices. Subsequent testing for these novel polymers will determine static and dynamic (wear-induced) antibiotic elution rates. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 97 - 97
1 Dec 2017
Ikeda S Uchiyama K Kishino S Nakamura M Yoshida K Minegishi Y Sugo K Fukushima K Takahira N Kitasato H Takaso M
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Aim. The preparation of antibiotic-containing polymethyl methacrylate (PMMA), as spacers generates a high polymerization heat, which may affect their antibiotic activity; it is desirable to use bone cement with a low polymerization heat. Calcium phosphate cement (CPC) does not generate heat on polymerization, and comparative elution testings are reported that vancomycin (VCM)-containing CPC (VCM-CPC) exceeded the antibiotic elution volume and period of PMMA (VCM-PMMA). Although CPC alone is a weak of mechanical property spacer, the double-layered, PMMA-covered CPC spacer has been created and clinically used in our hospital. In this study, we prepared the double-layered spacers: CPC covered with PMMA and we evaluated its elution concentration, antimicrobial activity and antibacterial capability. Method. We prepared spherical, double-layered, PMMA-coated (CPC+PMMA; 24 g CPC coated with 16 g PMMA and 2 g VCM) and PMMA alone (40 g PMMA with 2 g VCM) spacers (5 each). In order to facilitate VCM elution from the central CPC, we drilled multiple holes into the CPC from the spacer surface. Each spacer was immersed in phosphate buffer (1.5 mL/g of the spacer), and the solvent was changed daily. VCM concentrations were measured on days 1, 3, 7, 14, 28, 56, and 84. Antimicrobial activity against MRSA and MSSA was evaluated by the broth microdilution method. After measuring all the concentration, the spacers were compressed at 5 mm/min and the maximum compressive load up to destruction was measured. Results. The VCM concentration of the CPC+PMMA spacer exceeded that of the PMMA spacer at all-time points; in particular, it was approximately 7.3 times (109.30 vs. 15.03 μg/mL) and approximately 9.1 times (54.47 vs. 6.50 μg/mL) greater on days 14 and 28, respectively. Using the broth microdilution method, we found that the CPC+PMMA spacer had higher antimicrobial activity than the PMMA model. On day 56, the PMMA spacer lost the capability to inhibit bacterial growth, but the CPC+PMMA spacer maintained this ability. The average maximum compressive load for the CPC+PMMA was 7.28 kN, and that of PMMA was 16.21 kN. Conclusions. The CPC+PMMA spacer was superior to PMMA alone in VCM elution volume and duration, so CP- C+PMMA may be effective for the treatment of MRSA and MSSA infection. The double-layered, antibiotic-loaded cement spacer may maintain antibacterial capability and sufficient strength


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_16 | Pages 20 - 20
1 Dec 2015
Borland S Fourie B Patel N Burton D Nayar D
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In bone and joint infections, several materials can be used for local antibiotic elution at site of infection. Polymethylmethacrylate (PMMA) cement is often used. Recently the use of antibiotic impregnated dissolvable synthetic pure calcium sulphate beads [Stimulan R]1 has been used as an alternative, due to several perceived advantages. We present our experience of using Calcium sulphate beads in infections involving the upper limb. From Jan 2012 to Jan 2015, we used Calcium sulphate beads in 7 complex upper limb infections including 1 elbow replacement, 2 infected non unions, 2 shoulder replacement, 1 wrist fusion and I ORIF elbow. We used combination of Vancomycin and Gentamicin in the beads, using manufacturer's mixing guide for optimum setting. Arthroplasty infections underwent explantation, addition of antibiotic impregnated calcium sulphate beads in the joint space, followed by a second stage, and systemic antibiotics. Fracture non-union cases had surgical debridement, calcium sulphate beads and systemic antibiotics. Follow up (6months to 2 years) indicate no recurrence of infection in any case. The most common organisms isolated were Coagulase negative staphylococcus and Staphylococcus aureus. Others included Group B Streptococcus, Serratia marscesens and Corynebacterium spp. In 2 of 7 cases there was significant drainage from the wound. This settled without further input. For fracture non-union fixation, there was no need to do second procedure to remove beads as they dissolve. In cases of staged revisions, the beads were inserted at first stage with microbiological clearance at 2nd stage. At present there are no reports in the literature of the use of this product in the upper limb. Our experience suggests use of dissolvable pure Calcium sulphate beads impregnated with selected antibiotics, is an effective adjunct to current treatments. Aseptic drainage has been reported and this was seen in some of our cases. It is postulated that the use of Calcium sulphate beads in more superficial joints may lead to more drainage. It may be necessary to avoid packing any beads in the subcutaneous spaces and using lower volumes in upper limb. Further work will include long-term follow up and any evidence of relapse or recurrence of infection


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_16 | Pages 135 - 135
1 Dec 2015
Chaturvedi A Barlow G Sharma H
Full Access

The management of chronic osteomyelitis is fraught with difficulties; a multi-disciplinary team approach is recommended for optimum outcome. Thorough debridement, dead space management and organism targeted antibiotic therapy the gives best clinical results. Calcium sulphate beads impregnated with antibiotic is an absorbable option for prolonged local antibiotic elution and dead space management. This study aims to analyse the early results of single stage management of osteomyelitis with antibiotic impregnated calcium sulphate beads. Following surgical debridement, calcium sulphate impregnated typically with tobramycin and/or vancomycin is inserted to obliterate the dead space. Intravenous antibiotics – typically teicoplanin and piperacillin-tazobactam – are administered until culture results permit rationalisation to narrow spectrum agents. Patients are followed up in Infectious Diseases and Orthopaedic clinics for a period of 12 months and discharged if quiescence is achieved. We conducted a retrospective analysis of our prospective database to identify patients treated with our single stage protocol for chronic osteomyelitis. We excluded patients that had (1) less than 6 months of follow up, (2) incomplete metal-ware removal, (3) patients lost to follow up. Fourteen patients (9 men, 5 women) with mean age of 41 (16–73) years and mean follow up of 9 (6–12) months were included in study. Eleven patients had previous surgeries involving internal fixation; the rest were primary osteomyelitis. Seven patients had washouts and removal of metal-ware procedures for osteomyelitis prior to referral to the bone infection service. Clinical, radiographic, and laboratory (microbiological, biochemical and haematological) methods were used to monitor response to treatment. Cierney-Mader classification determined that 8 patients were classed as type A (normal hosts); 4 as BS (systemically compromised); 2 as BLS (locally and systemically compromised). Anatomic analysis suggested 7 were Type 1 (medullary osteomyelitis); the remaining 7 were type 3 (localised disease). Five patients were staged IA; three each staged IIIA and IIIBS; and one each staged IBs, IBLS, IIIBLS. Staphylococcus Aureus was the commonest causative organism. Follow up radiograph monitoring indicated absorption of the beads by 3 months. There has been no evidence of recurrence based on clinical, radiographic and blood based parameters in all patients. Short-term results of single stage osteomyelitis treatment with calcium sulphate beads impregnated with antibiotics are promising


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 83 - 83
1 Dec 2016
Gehrke T
Full Access

The two-staged exchange for periprosthetic joint infection (PJI) has become the “gold standard” worldwide. Based on the first implementation of mixing antibiotics into bone cement by Prof. Buchholz in the 1970s, the ENDO-Klinik followed a distinct one staged exchange for PJI in over 85 % of all our infected cases until today. Looking carefully at current literature and guidelines for the PJI treatment, there is no clear evidence, that a two-staged procedure has a clearly higher success rate than a one-staged approach. Although postulated in relevant articles, most recommendations, e.g. duration of antibiotics, static vs. mobile spacer, interval of spacer retention, cemented vs. uncemented implant fixation, are based on Level IV to III evidence studies or expert opinions, rather than on prospective randomised or comparative data. Potentially a cemented one-stage exchange offers certain advantages, as mainly based on need for only one operative procedure, reduced antibiotics & hospitalization time and reduced relative overall costs. In order to fulfill a one-staged approach with the above described potential success, there are obligatory pre-, peri- and postoperative details, which need to be meticulously respected. The absolute mandatory infrastructural requirement is based on the clear evidence of the bacteria in combination with a distinct patient specific plan, by an experienced microbiologist, for following topical antibiotics in the bone cement with combined systemic antibiotics. Mandatory preoperative diagnostic testing is based on the joint aspiration with an exact identification of the bacteria. The presence of a positive bacterial culture and respective antibiogramm is essential, to specify the antibiotics loaded into the bone cement, which allows a high topical antibiotic elution directly at the surgical site. A specific treatment plan is generated by a microbiologist. Contraindications for a one-staged exchange include: failure of >2 previous one-staged procedures, infection spreading to the nerve-vessel bundle, unclear preoperative bacteria specification, unavailability of appropriate antibiotics, high antibiotic resistance. The surgical success relies not only on the complete removal of all preexisting hardware material (including cement and restrictors), furthermore an aggressive and complete debridement of any infected soft tissues and bone material is needed. Mixing antibiotics into the cement needs to fulfill the following criteria: Appropriate antibiogramm, adequate elution characteristics, bactericidal (exception clindamycin), powder form (never use liquid AB), maximum addition of 10 %/PMMA powder. Current principles of modern cementing techniques should be applied. Postoperative systemic antibiotic administration is usually followed for only 10–14 days (exception: streptococci). We recommend an early and aggressive mobilization within the first 8 days postoperatively, due to the cemented fixation an immediate mobilization under full weight bearing becomes possible in most cases. Persistence or recurrence of infection remains the most relevant complication in the one-staged technique. As failure rates with a two-staged exchange have been described between 9% and 20% in non-resistant bacteria, the ENDO-Klinik data shows comparative results after 8–10 years of follow up. In summary a cemented one-stage exchange offers various advantages. Mainly the need for only one operation, shorter hospitalization, reduced systemic antibiotics, lower overall cost and relative high patient satisfaction. However, a well-defined preoperative planning regime including an experienced microbiologist is absolutely mandatory


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 126 - 126
1 Apr 2017
Parvizi J
Full Access

The burden of periprosthetic joint infection (PJI) continues to rise and the management of this dreaded complication continues to pose challenges to the orthopaedic community. Dr Buchholz from the Endo Klinik has been credited for reporting the initial observation that addition of antibiotic to polymethylmethacrylate (PMMA) cement lead to better ability to deliver higher concentrations of antibiotic to the joint milieu and avoid administration of high doses of systemic antibiotics with potential for systemic toxicity. Addition of antibiotics to PMMA cement has continued to be an important aspect of managing patients with chronic PJI. The rationale for this practice is that higher doses of local antibiotics can be reached without placing the patients at risk of systemic toxicity. Whether a one-stage or a two-stage exchange arthroplasty is being performed, antibiotics that can withstand the exothermic reaction of PMMA and are able to elude from cement are added at various doses to the PMMA for later delivery. Although this practice continues to be almost universal, there are a few unknowns. First of all, a recent study raised a valid question regarding this practice. Though intuitively logical, addition of antibiotics to PMMA spacers has not been scrutinised by any level 1 study and hence one is not able to prove that this practice does indeed accomplish its intended objectives of reducing recurrence or persistence of infection. Orthopaedic community is advised to seek avenues to generate this much-needed evidence. The other main unknown is how much, and in some instances which antibiotic, needs to be added to the PMMA cement. Some authorities have declared that antibiotics can be added at high doses, with an average total dose of 10.5 g of vancomycin (range, 3–16 g) and 12.5 g of gentamicin (range, 3.6–19.2 g) in one study, to PMMA cement without the fear of systemic toxicity. In recent years, renal toxicity and other systemic adverse effects have been attributed to addition of high doses of antibiotics to cement. I have personally witnessed such adverse reactions in a few patients. Although initially I was inclined to “blame” the concurrent administration of systemic antibiotics for the renal toxicity that patients developed following insertion of spacer, selective nephrotoxicity (i.e. reaction to aminoglycoside that was only present in the spacer and not systemically administered) and resolution of the nephrotoxicity upon removal of antibiotic spacer, convinced me that our nephrology colleagues have a valid reason to be concerned about addition of high doses of antibiotics to PMMA spacers. What has become clear is that high viscosity cements containing MA-MMA copolymers have been shown to have better antibiotic elution profiles than other PMMA formulations. So when fashioning a spacer in the operating room the surgeon needs to be aware of the differences in elution profile of antibiotics from PMMA and individualise the dose of antibiotics being added to spacer based on the type and viscosity of cement being used and the renal status of the patient. Thus, systemic toxicity caused by addition of antibiotics to cement spacer appears to be a real issue in some circumstances and this needs to be born in mind when managing patients with PJI. There are numerous other issues related to the use of antibiotic cement spacers. In the hip, the lack of adequate offset and limited portfolio of products result in laxity in the soft tissue and subsequent dislocation of the hip. In addition, the dose and type of antibiotic in the premanufactured spacers, at least in the US, are inadequate to lead to a substantial delivery of antibiotics in the local tissues. Because of these issues, I prefer to fabricate “customised” spacers for each patient that I operate on


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_13 | Pages 59 - 59
1 Nov 2015
Gehrke T
Full Access

The two-staged exchange for periprosthetic joint infection (PJI) has become the “gold standard” worldwide. Based on the first implementation of mixing antibiotics into bone cement by Prof. Buchholz in the 70's, the ENDO-Klinik followed a distinct one-staged exchange for PJI in over 85% of all our infected cases until today. Looking carefully at current literature and guidelines for the PJI treatment, there is no clear evidence, that a two-staged procedure has a clearly higher success rate than a one-staged approach. Although postulated in relevant articles, most recommendations, e.g. duration of antibiotics, static vs. mobile spacer, interval of spacer retention, cemented vs. uncemented implant fixation, are based on level IV to III evidence studies or expert opinions, rather than on prospective randomised or comparative data. Potentially a cemented one-stage exchange offers certain advantages, as mainly based on need for only one operative procedure, reduced antibiotics & hospitalization time and reduced relative overall costs. In order to fulfill a one-staged approach with the above described potential success, there are obligatory pre-, peri- and post-operative details, which need to be meticulously respected. The absolute mandatory infrastructural requirement is based on the clear evidence of the bacteria in combination with a distinct patient specific plan, by an experienced microbiologist, for the topical antibiotics in the bone cement with combined systemic antibiotics. Mandatory pre-operative diagnostic testing is based on the joint aspiration with an exact identification of the bacteria. The presence of a positive bacterial culture and respective antibiogramm is essential, to specify the antibiotics loaded to the bone cement, which allows a high topical antibiotic elution directly at the surgical site. A specific treatment plan is generated by a microbiologist. Contraindications for a one-staged exchange include: failure of > 2 previous one-staged procedures, infection spreading to the nerve-vessel bundle, unclear pre-operative bacteria specification, unavailability of appropriate antibiotics, high antibiotic resistance. The surgical success relies not only on the complete removal of all preexisting hardware material (including cement and restrictors), furthermore an aggressive and complete debridement of any infected soft tissues and bone material is needed. Mixing antibiotics to the cement needs to fulfill the following criteria: Appropriate antibiogramm, adequate elusion characteristics, bactericidal (exception clindamycin), powder form (never use liquid AB), maximum addition of 10%/PMMA powder. Current principles of modern cementing techniques should be applied. Post-operative systemic antibiotic administration is usually followed for only 10–14 days (exception: streptococci). We recommend an early and aggressive mobilization within the first 8 days post-operatively due to the cemented fixation an immediate mobilization under full weight bearing becomes possible in most cases. Persistence or recurrence of infection remains the most relevant complication in the one-staged technique. As failures rates with a two-staged exchange have been described between 9% and 20% in non-resistant bacteria, the ENDO-Klinik data shows comparative results after 8–10 years of follow up, which were confirmed independently also by some other international reports and study groups. In summary a cemented one-stage exchange offers various advantages. Mainly the need for only one operation, shorter hospitalization, reduced systemic antibiotics, lower overall cost and relatively high patient satisfaction. However a well-defined pre-operative planning regime including an experienced microbiologist is absolutely mandatory


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 66 - 66
1 May 2016
Caraan N Windhager R Kuehn K
Full Access

BACKGROUND. This scientific work is a non-interventional, experimental and prospective comparative study of two very high-viscosity PMMA bone cements: DePuy CMW 2G and Palacos® fast R+G. Reference product: Palacos® R+G. Fast-setting PMMA bone cements are used in the endoprothetics of the patella and knee (in Australia) and are also used to cement an artificial acetabulum (in the UK). Are there any differences regarding the characteristics of the two fast-setting PMMA bone cements?. MATERIALS AND METHODS. All cements were mixed as specified by the manufacturer and analysed on the following parameters: handling properties (mixing, waiting, working and hardening phase), powder/liquid-ratio, mechanical properties (ISO 5833:2002 and DIN 53435), fatigue strength (ISO 16402) and elution profile. All tests were done in an acclimatised laboratory with temperatures set at 23.5°C ± 0.5°C and a humidity of >40%. Of two batch numbers, 11 units of each bone cement were tested. RESULTS AND DISCUSSION. The handling properties of the two tested PMMA bone cements Palacos® fast R+G and CMW 2G are highly similar (n=12). CMW 2G reaches the mixing and waiting phase approximately 20s later than Palacos® fast R+G. Palacos® fast R+G has a similar working, but a shorter hardening phase than CMW 2G. In addition, working with Palacos® fast R+G was advantageous due to its green dye. Palacos® fast R+G has a higher powder/liquid-ratio of 2.550. Due to the higher powder percentage, the cement has a shorter mixing and waiting phase than CMW 2G with a ratio of 2:1. Both analysed bone cements fulfil the quasi-static properties of ISO 5833:2002 and DIN 53435. Palacos® fast R+G was far superior in its ISO compressive strength (MPa) shown through one-way analysis of variance (ANOVA) (p<0.01) and independent two sample t-test (p<0.01) at 0.05 level of significance (n=20)(Fig. 1). CMW 2G has a higher quasi-static ISO bending strength (MPa) than Palacos® fast R+G, but the same test shows a much higher fatigue strength (ISO 16402) of Palacos® fast R+G (n=5) (Fig. 2). Palacos® R+G and Palacos® fast R+G show a similar elution profile (n=3), whereas CMW 2G shows a much lower antibiotic elution over time. CMW 2G releases approximately 1/3 of gentamicin per mould body after 24h. After day 3 and 5, CMW 2G has a significantly lower gentamicin release than Palacos® fast R+G (Fig. 3). Palacos® fast R+G has a higher gentamicin release, due to its hydrophilic polymer basis, which is identical to Palacos® R+G. CMW 2G contains pure PMMA and is therefore more hydrophobic than the other two tested cements. CONCLUSION. Handling with Palacos® fast R+G was advantageous due to its green dye. Because of the shorter handling phases of Palacos® fast R+G, it is superior as it minimises the length of surgeries. Mechanical properties according (ISO 5833:2002 and DIN 53435) were comparable. Palacos® fast R+G has a statistically significant higher ISO compressive strength (MPa). Palacos® fast R+G also showed higher fatigue strength (ISO 16402). Palacos® fast R+G was far superior in matters of gentamicin release over time


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 89 - 89
1 Feb 2015
Gehrke T
Full Access

The two-staged exchange for periprosthetic joint infection (PJI) has become the “gold standard” worldwide. Based on the first implementation of mixing antibiotics into bone cement by Prof. Buchholz in the 70's, the ENDO-Klinik followed a distinct one staged exchange for PJI in over 85% of all our infected cases until today. Looking carefully at current literature and guidelines for the PJI treatment, there is no clear evidence, that a two-staged procedure has a clearly higher success rate than a one-staged approach. Although postulated in relevant articles, most recommendations, e.g. duration of antibiotics, static vs. mobile spacer, interval of spacer retention, cemented vs. uncemented implant fixation, are based on level IV to III evidence studies or expert opinions, rather than on prospective randomised or comparative data. Potentially a cemented one-stage exchange offers certain advantages, as mainly based on need for only one operative procedure, reduced antibiotics & hospitalization time and reduced relative overall costs. In order to fulfill a one-staged approach with the above described potential success, there are obligatory pre-, peri- and post-operative details, which need to be meticulously respected. The absolute mandatory infrastructural requirement is based on the clear evidence of the bacteria in combination with a distinct patient specific plan, by an experienced microbiologist, for following antibiotics in the bone cement with combined systemic antibiotics. Mandatory preoperative diagnostic test is based on the joint aspiration with an exact identification of the bacteria. The presence of a positive bacterial culture and respective antibiogramm is essential, to specify the antibiotics loaded to the bone cement, which allows a high topic antibiotic elution directly at the surgical side. A specific treatment plan is generated by an microbiologist. Contraindications for a one staged exchange include: failure of >2 previous one-staged procedures, infection spreading to the nerve-vessel bundle, unclear preoperative bacteria specification, unavailability of appropriate antibiotics, high antibiotic resistance. The surgical success relies not only on the complete removal of all preexisting hardware material (including cement and restrictors), furthermore an aggressive and complete debridement of any infected soft tissues and bone material is needed. Mixing antibiotics to the cement needs to fulfill the following criteria: Appropriate antibiogramm, adequate elution characteristics, bactericidal (exception clindamycin), powder form (never use liquid AB), maximum addition of 10%/PMMA powder. Current principles of modern cementing techniques should be applied. Postoperative systemic antibiotic administration is usually followed for only 10–14 days (exception: streptococci). We recommend an early and aggressive mobilization within the first 8 days postoperatively, due to the cemented fixation an immediate mobilization under full weight bearing becomes possible in most cases. Persistence or recurrence of infection remains the most relevant complication in the one-staged technique. As failures rates with a two-staged exchange have been described between 9% and 20% in non-resistant bacteria, the ENDO-Klinik data shows comparative results after 8–10 years of follow up, which were confirmed independently also by some other international reports and study groups. In summary a cemented one-stage exchange offers various advantages. Mainly the need for only one operation, shorter hospitalization, reduced systemic antibiotics, lower overall cost and relative high patient satisfaction. However, a well-defined preoperative planning regime including an experienced microbiologist are absolutely mandatory


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_22 | Pages 65 - 65
1 May 2013
Gehrke T
Full Access

The two-staged exchange for periprosthetic joint infection (PJI) has become the “gold standard” worldwide. However, based on the first implementation of mixing antibiotics into bone cement by Prof. Buchholz in the 1970s, the ENDO-Klinik followed a distinct one staged exchange for PJI in over 85% of all our infected cases until today. Looking carefully at current literature and guidelines for the PJI treatment, there is no clear evidence, that a two-staged procedure has a clearly higher success rate than a one-staged approach. A cemented one-stage exchange offers certain potential advantages, mainly the need for only one operative procedure resulting in reduced antibiotic administration, hospitalisation time, and relative overall costs. In order to fulfill a one-staged approach which results in the above described potential success, there are obligatory pre-, peri- and post-operative details, which need to be meticulously respected. The absolute mandatory infrastructural requirement is a clear knowledge of the infecting organism in combination with a distinct patient specific plan recommended by an experienced microbiologist, for the local antibiotics in the bone cement and the systemic antibiotics, administered to the patient post-operatively. This requires a mandatory pre-operative diagnostic test based on the joint aspiration with an exact identification of the bacteria. The presence of a positive bacterial culture and respective antibiogramm is essential, to identify the specific antibiotics loaded to the bone cement, which allows a high topic antibiotic elution directly at the surgical side. Contraindications for a one staged exchange include: . Failure of > 2 previous one-staged procedures. Infection spreading to the nerve-vessel bundle, which allows no radical debridement. Unclear pre-operative bacteria specification. Unavailability of appropriate antibiotics due to high antibiotic resistance. The surgical success relies not only on the complete removal of all foreign material (including cement and restrictors), but also on the required aggressive and complete debridement of any infected soft tissues and bone material. The mixing of antibiotics into the cement must fulfill the following criteria: Appropriate antibiogramm, adequate elusion characteristics, bactericidal (exception clindamycin), powder form (never use liquid AB), maximum addition of 10%/PMMA powder. Current principles of modern cementing techniques should be applied. Post-operative systemic antibiotic administration is usually followed for only 10–14 days (exception: streptococci). Persistence or recurrence of infection remains the most relevant complication in the one-staged technique. As failure rates with a two staged exchange have been described between 9% and 20% in non-resistant bacteria, the ENDO-Klinik data shows comparative results after 8 to10 years of follow-up. In summary a cemented one-stage exchange offers various advantages. Mainly the need for only one operation, shorter hospitalisation, reduced systemic antibiotics, lower overall cost and a relatively high patient satisfaction rate. However, a well-defined pre-operative planning regime including an experienced surgeons team and microbiologist are absolutely mandatory for its overall success


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 632 - 638
1 Jun 2024
Hart CM Kelley BV Mamouei Z Turkmani A Ralston M Arnold M Bernthal NM Sassoon AA

Aims

Delayed postoperative inoculation of orthopaedic implants with persistent wound drainage or bacterial seeding of a haematoma can result in periprosthetic joint infection (PJI). The aim of this in vivo study was to compare the efficacy of vancomycin powder with vancomycin-eluting calcium sulphate beads in preventing PJI due to delayed inoculation.

Methods

A mouse model of PJI of the knee was used. Mice were randomized into groups with intervention at the time of surgery (postoperative day (POD) 0): a sterile control (SC; n = 6); infected control (IC; n = 15); systemic vancomycin (SV; n = 9); vancomycin powder (VP; n = 21); and vancomycin bead (VB; n = 19) groups. Delayed inoculation was introduced during an arthrotomy on POD 7 with 1 × 105 colony-forming units (CFUs) of a bioluminescent strain of Staphylococcus aureus. The bacterial burden was monitored using bioluminescence in vivo. All mice were killed on POD 21. Implants and soft-tissue were harvested and sonicated for analysis of the CFUs.