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Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection and Revision The Use of Synthetic Pure Calcium Sulfate (Stimulan®) Impregnated with Vancomycin & Tobramycin Edward J. McPherson, MD, FACS† • Matthew V. Dipane, BA† • Sherif M. Sherif, MD† Abstract:
This study reviews the clinical results using commercially pure, synthetic antibiotic-loaded
Calcium Sulfate dissolvable beads (Stimulan, Biocomposites, Ltd., Keele, UK) in 250 cases of aseptic and septic revision total hip and total knee arthroplasty. A set protocol of Vancomycin and Tobramycin antibiotic was used in all cases. The rate of wound drainage in this series was 3.2%. Wound drainage was generally seen in cases using higher bead volumes. The incidence of heterotopic bone formation was 1.2%. There were nine failures in this study, six of which were due to infection. We feel that commercially pure, synthetic antibiotic-loaded dissolvable beads are an acceptable delivery tool for local antibiotic delivery in aseptic and septic revision joint arthroplasty of the hip and knee. Further studies are needed to examine the potential of improving outcomes of periprosthetic joint infection with this particular local antibiotic delivery system.
Key words: Stimulan, Calcium Sulfate, Antibiotic Beads, Periprosthetic Infection, Revision Arthroplasty.
Level of Evidence: AAOS Therapeutic Study Level IV.
with radical debridement surgery, modular bearing Periprosthetic joint infection (PJI) is a devastating exchange, copious lavage, and perioperative complication that is potentially a limb and life antibiotic therapy. When a biofilm is present, the threatening condition.The extent of the infection infection is considered chronic. In this scenario, is related to many factors including the health of the biofilm prevents eradication of bacteria and the host patient, the condition of the local soft thus implants must be removed along with a radical tissues, and the length of time the infection has been debridement of bone and soft tissue. Resection of present within the joint. Treatment of periprosthetic implants most commonly is performed in a two infection currently follows established algorithms stage protocol. At some centers that focus on PJI, that have proven successful. Treatment depends single stage protocols are utilized. With either upon the presence of the bacterial biofilm which envelops the joint prosthesis and adjacent bone. In an acute infection, the biofilm is not established. † LA Orthopedic Institute, Los Angeles, CA Treatment is focused on preservation of the implant, Reconstructive Review • March 2013 Joint Implant Surgery & Research Foundation
protocol, success is particularly dependent upon the turn impedes wound healing and causes a wound to quality of joint debridement.
Antibiotic therapy in the surgical treatment of a The purpose of this study is to examine the initial PJI is an important adjuvant therapy. Antibiotic review of the use of commercially pure, synthetic penetration into the local infected area can be antibiotic-loaded dissolvable Calcium Sulfate problematic. Specifically, local devascularization beads (Stimulan) in their application in treating two of infected tissues can prevent local antibiotic groups of patients. One group contains patients with delivery. Additionally, any residual biofilm can periprosthetic infection. The other contains patients undergoing revision joint arthroplasty. Historically systems offer a solution to this problem. Antibiotic this latter group has a higher known risk of impregnated cement spacers are a useful tool, periprosthetic infection.e review although a majority of the antibiotic placed into the outcomes and complications and compare our cement does not elute into the host environment. findings to previous studies employing processed Non-dissolvable antibiotic polymethylmethacrylate calcium sulfate derived from gypsum product. To (PMMA) beads can provide higher antibiotic our knowledge, this is the first study reporting on concentrations, but fabrication is tedious. the use of commercially pure, synthetic antibiotic- Additionally, it is often difficult to locate and loaded Calcium Sulfate in the treatment of two such remove all beads at reconstruction.
A local delivery system with dissolvable Calcium Sulfate has been developed to assist in the targeted Materials & Methods
Between January 2010 and September 2012, 342 Stimulan (Biocomposites Ltd., Keele, UK) is a revision THA and TKA procedures were performed. synthetic hemihydrate form of Calcium Sulfate. This included aseptic revisions, two stage septic It is produced using a synthetic process resulting revisions, and one stage DECRA (Debridement, in 100% purity with no traces of potentially toxic modular Exchange, Component Retention, IV impurities which has been associated with naturally Antibiotic) procedures for acute PJI. During this occurring mineral sources of Calcium Sulfate. It time we used dissolvable antibiotic beads in 250 of is biocompatible, composed of hydrophilic crystals, these cases. The antibiotic combination used in this soft after hydration, and disappears on X-rays after series was a preset protocol consisting of one (1) two to three weeks when placed within a joint gram of Vancomycin powder and 240mg of liquid Tobramycin mixed with 10cc of Stimulan powder Stimulan also has the advantage of delivering (see technique below). For two-stage procedures a wider spectrum of antibiotic combinations for infected TKA and THA, Stimulan antibiotic into the joint. It cures at a low temperature, thus beads were inserted both at the time of resection allowing heat-sensitive antibiotics to be mixed with arthroplasty and reimplantation.
Stimulan. This is in contrast to PMMA in which Preoperatively, all patients were staged for only heat-stable antibiotics can be used. Even with periprosthetic infection risk according to the these advantages, there has been concern with using Musculoskeletal Infection Society – Americas dissolvable antibiotic-loaded Calcium Sulfate. The integrity of each The main concern has been with postoperative patient's immune defense system was assessed and wound drainage. Prior to Stimulan, dissolvable Calcium Sulfate products were derived from Aseptic revisions in the MSIS-A classification were gypsum, a natural product mined and processed considered a Stage Zero. All revision procedures into Calcium Sulfate. The processing of gypsum were preoperatively aspirated by the surgeon (ejm) creates a product that has a relatively low pH and with cell count and culture analysis. Pre-operative contains residual by-products that may illicit an Westergren Sedimentation Rates and Quantitative inflammatory reaction when the product is placed CRP were also obtained on all patients. Clinical into a joint wound. The inflammatory reaction in scoring was performed on all patients including Reconstructive Review • March 2013 Harris Hip and Oxford scores for hips and Knee Cobalt cement were typically used. One gram of Society and Oxford scores for knees. Perioperative Vancomycin powder was placed in each 40 gram and post-operative complications were recorded. bag of cement.
Radiographs were obtained at 3 months and 1 year For knee cases, the Stimulan beads were delivered along the medial and lateral gutters of the knee, At the time of knee resection arthroplasty, the just before closure. A 10 french silicone Blake knee was stabilized with an articulated antibiotic- drain (Ethicon, Inc., San Angelo, TX) was placed loaded PMMA spacer. When the knee was unstable, along the lateral gutter and the arthrotomy closed the leg was stabilized with an antibiotic-loaded in midflexion over a bump. No beads were placed PMMA endofusion device with medullary rods in the subcutaneous layer. Superficial subcutaneous inserted into the femur and tibia. Cobalt cement drains were placed as indicated. The deep drain (Biomet, Warsaw, IN) was used in resection was always removed between 24 and 36 hours. and reimplantation/revision procedures. For The superficial drain(s) was removed between resections, 5 grams of Vancomycin powder and 48 and 72 hours. In the two stage septic revision 3.6 grams of Tobramycin powder were mixed into group, a compressive Robert-Jones dressing was each 40 gram bag of Cobalt cement. Typically placed on the leg for 5-7 days, both at resection and 3-5 bags of cement were used at resection. For reimplantation. Figures 1 and 2 (see Appendices) revision or reimplantation procedures, 2-3 bags of demonstrate surgical technique and placement of the Stimulan beads.
Figures 1a - 1e: Radiographs of 65-year-old male who underwent a two-stage revision protocol for a chronic periprosthetic infection of his left TKA. The patient suffers from diabetes. Figure 1b: Postoperative radiograph of resection arthroplasty. The knee was stabilized with a Vanguard (Biomet, Warsaw, IN) prostalac arthroplasty. 10cc of Stimulan antibiotic beads were placed into the medial and lateral gutters at closure. Note deep and superficial drains placed at closure. This case was one of the initial members of this study, thus accounting for the modest use of beads. Figure 1a: Preoperative standing AP radiograph of Figure 1c: Preoperative AP radiograph of left TKA. Aspiration cultures grew Staphylococcus knees prior to reimplantation. This radiograph warneri and Stenotrophomonas maltophilia. was taken 9 weeks after resection arthroplasty. All Calcium Sulfate beads have dissolved. Preoperative aspiration of the knee was negative. Figure 1d: Postoperative Figure 1e: Standing AP radiograph AP radiograph taken at reimplantation 18 months after surgery. The knee was reimplantion surgery. reconstructed using the All Calcium Sulfate Vanguard revision knee beads have dissolved. system (Biomet, Warsaw, The patient remains IN). At closure 20cc infection free with of Stimulan antibiotic knee range of 0-125 beads were placed into the knee joint. Again note deep drain placed into knee. Reconstructive Review • March 2013 Joint Implant Surgery & Research Foundation
Figures 2a – 2d: Radiographs of a 57-year-old male who underwent a single-stage revision protocol for Nickel hypersensitivity and clinical pain of his left TKA. Figure 2a: Preoperative Figure 2b: Postoperative AP standing AP radiograph. radiograph of revision TKA. 10cc Note well-fixed TKA of Stimulan antibiotic beads were implants. The patient placed into the medial and lateral had knee range of 0-130 gutters of the knee. Note drain degrees, but had a placed into knee joint at closure. persistently large knee effusion and chronic pain. Figure 2c: Postoperative Figure 2d: Postoperative standing AP radiograph standing AP radiograph taken 2 months after taken 8 months after revision surgery. All revision surgery. The knee Calcium Sulfate beads has regained knee range have dissolved. Also note of 0-135 degrees. Knee that the knee effusion has effusion remains minimal. At the time of hip resection, the hip was stabilized reconstruction, the acetabular socket was cemented with an articulated antibiotic-loaded PMMA hip into the cage with Cobalt cement. One gram of spacer. The Modular Stage One hip spacer system Vancomycin powder was mixed into each 40 gram was used (Biomet, Warsaw, IN). When segmental bag of cement.
deficiencies were present in the acetabulum, an antibiotic-loaded PMMA spacer was formed For hip cases, the Stimulan antibiotics beads were in-situ in the pelvis/acetabulum using a large delivered into the deep hip space inferior to the monopolar head trial as a mold. The cement acetabulum and around the proximal femur. A 10 was secured with two to four 6.5mm titanium french Blake Drain was placed just under the Tensor cancellous screws placed partly into bone to serve Fascia layer. Additional subcutaneous drains were as rebar posts; this prevented spacer displacement. placed as indicated. No beads were placed in the The screws were covered entirely with cement subcutaneous layer. The Tensor Fascia drain was (screwdriver holes were filled with bone wax to always removed between 24 and 36 hours. The allow removal at reconstruction). Cobalt cement superficial drains were pulled between 48 and 72 was used at resection arthroplasty with the same hours. In the two stage septic revision group, a antibiotic combination as the knee. For revision or spica brace (set between 20-70 degrees) was used reimplantation procedures almost all cases were implanted with cementless reconstruction systems. reimplantation (4-6 weeks). Figures 3 and 4 (see When a reconstruction cage was used for acetabular Appendices) demonstrate surgical technique and placement of Stimulan beads.
Reconstructive Review • March 2013 Figures 3a – 3c: Radiographs of a 72-year-old male who underwent a single-stage revision protocol for prosthetic femoral- acetabular impingement and clinical pain of his right THA. Figure 3a: Preoperative AP radiograph of pelvis. Figure 3b: Postoperative AP radiograph of revision Figure 3c: Postoperative AP radiograph taken 3 Note small amount of heterotopic bone near lateral THA. 10cc of Stimulan antibiotic beads were placed months after revision surgery. All Calcium Sulfate acetabulum and lesser trochanter. within the hip joint, mainly inferiorly. The beads beads have dissolved. Note no new heterotopic gravitated to this region as this area was dissected bone has formed. This patient did not receive any to remove the heterotopic bone and scar tissue from perioperative treatment to prevent heterotopic bone the proximal femur. formation (i.e., no radiation or Indocin). Figures 4a – 4f: Radiographs of a 64-year-old male who underwent a two-stage revision protocol for a chronic periprosthetic infection of his right THA. The patient suffers from hypertrophic osteoarthritis and DISH. Figure 4a: Preoperative AP radiograph of Figure 4b: Postoperative radiograph of resection Figure 4c: Preoperative AP radiograph of pelvis pelvis showing infected right THA. Preoperative arthroplasty. The hip was stabilized with a prior to reimplantation surgery. This radiograph aspiration grew Staphylococcus epidermidis. Note Modular Stage One (Biomet, Warsaw, IN) was taken 8 weeks after resection arthroplasty. All endosteal resorption of bone around proximal antibiotic loaded methyl methacrylate articulated Calcium Sulfate beads have dissolved. Preoperative femoral stem. spacer. 40cc of Stimulan antibiotic beads were aspiration of the hip was negative. placed into the hip joint. Note drain that was placed underneath the tensor fascia layer at Figure 4d: Postoperative AP radiograph of pelvis Figure 4e: AP radiograph of pelvis taken 5 weeks Figure 4f: AP radiograph of pelvis taken 3.5 at reimplantation surgery. The acetabulum was after reimplantation surgery. All Calcium Sulfate months after reimplantation surgery. No heterotopic reconstructed with a porous cup cage (Signature beads have dissolved. Implants show stable initial bone has formed. Implants maintain initial biologic Orthopaedics, Chatsville, AU) with screws. A Magnum cup (Biomet, Warsaw, IN) was cemented into the cup cage. A dual articulating bearing was utilized (Biomet, Warsaw, IN). The femur was reimplanted with an Arcos modular stem (Biomet, Warsaw, IN). At closure, 40cc of Stimulan antibiotic beads were placed into the hip joint. Reconstructive Review • March 2013


Joint Implant Surgery & Research Foundation
Antibiotic Bead PreparationThis study utilized commercially pure, synthetic neutral pH balanced Calcium Sulfate (Stimulan). The rapid cure kit was used which includes 10cc (20gm) of Calcium Sulfate, 2 pre- measured mixing solution bulbs, 1 syringe, 1 pellet mold, and 1 spatula. The mold produces three different sizes for the beads (3, 4.8, and 6mm) as demonstrated in Figure 5 (See Appendices).
For this study, one gram of Vancomycin powder is added to 10cc (20gm) of Calcium Figure 5: Photograph showing Stimulan Bead Set. The blue plate is a sterile, silicone mat that can make 3 Sulfate and the two powders different sized beads (3, 4.8, and 6mm). In this series we primarily used 3 and 4.8mm beads to increase overall surface area and allow for faster dissolution of Calcium Sulfate. The beads shown here are from a 10cc batch of are well mixed. The mixture is Stimulan. The smaller beads are 3mm diameter beads. The larger beads are 4.8mm diameter beads. then added to 240mg (40mg/ cc) of liquid Tobramycin in a plastic mixing bowl provided in the kit. Ingredients average volume was different for each of the four are mixed for 30 seconds until "doughy." The different categories and all are listed in Table 1 (see paste is then applied with a spatula into a silicone bead mold and left to set for 10 to 15 minutes with a typical OR room temperature of 60-62º The incidence of wound drainage in this study was Once set, the beads are harvested relatively low considering the overall complexity of and kept in a sterile container until used.
the cases. There were eight cases (3.2%) of post- operative wound drainage requiring intervention. All patients were followed up for a minimum of Intervention included lavage and debridement, 3 months. Failure was recognized as the need for wound vac placement, and/or application of component removal for any reason. Monitoring for a compressive dressing on the wound. When infection included clinical exam with C-reactive the surgical wound began to drain, the post- protein tests at 3 months, 6 months, and one operative thromboembolic prophylaxis regimen year post-operatively. A suspicion of infection was modified, usually by using mechanical foot prompted a joint aspiration. For patients undergoing pumps, until wound drainage resolved. At the time reimplantation procedures, a pre-operative negative of debridement surgery, the old Stimulan beads culture from joint aspiration was mandatory. were removed and new beads were inserted into the wound. There were five cases (3.5%) of knee wound drainage, with two cases requiring surgical wound lavage and debridement. There were three The volume of Stimulan antibiotic-loaded beads cases (2.8%) of hip wound drainage, with two cases used for each procedure ranged from 5cc to 70cc requiring surgical wound lavage and debridement.
in hip cases and 5cc to 50cc in knee cases. As early cases showed no significant clinical problems, Heterotopic bone formation was identified in the volume of Stimulan beads was gradually three cases (1.2%). Heterotopic bone formation increased. The upper limit of bead volume was occurred in one knee case (resection arthroplasty dependant upon the ability to close the deep soft with static spacer) and two hip cases (one resection tissue envelope with a tension free closure. The arthroplasty and one reimplantation procedure). Reconstructive Review • March 2013 Heterotopic ossification was seen generally when of utilizing this particular carrier in septic and a large volume of Stimulan was used (average aseptic revision joint arthroplasty of the hip and 33cc per case). In all cases, the heterotopic bone knee. The strategy of using a localized antibiotic was considered mild, rated Brooker I-II class. The delivery system is that it avoids the potential character of the heterotopic bone in the two cases toxicity of intravenous antibiotics. The side effects that were re-operated (for reimplantation) was of even short courses of IV antibiotics are well considered thin and "wispy." It was easily removed from the surrounding tissues. In review of the post- into a joint replacement has already been shown operative radiographs, the heterotopic bone formed to deliver antibiotics up to 50 times greater than in areas where the Stimulan beads were densely MIC levels for many pathogenic bacteria found in orthopaedic infections.A local antibiotic delivery system is appealing, as it offers a high local In two-stage hip and knee procedures, we were able concentration of the antibiotics with low serum to inspect the surgical wounds at reimplantation. levels. In contrast, antibiotic-loaded bone cement The time between resection and reimplantation (PMMA) has historically been an alternative system ranged from 9 to 15 weeks, with an average of used for local antibiotic delivery, but there are 12 weeks. In all cases, there were no observable problems with this method. Firstly, the antibiotic beads remaining. In twenty percent of the cases we is released by surface bleaching, not elution. This noticed that the synovium was coated with a thin white layer of material that could not be rubbed There is also the need for a second surgery to away. This white material was typically located remove the cement beads in single stage procedures. within the medial and lateral gutters of knee cases Furthermore, only heat stable antibiotics can be and in the infra-acetabular areas of hips. Transection utilized with PMMA. Biodegradable delivery of synovial specimens showed that the white systems are more attractive because they provide material was only located on the superficial surface solutions for these issues encountered with the of the synovial tissue. The white coating was PMMA method of antibiotic delivery generally observed when bead volumes of 20cc or more were used.
Calcium Sulfate has been employed as a bone void filler for a long time and its popularity Out of our 250 procedures there were 29 as a local antibiotic delivery system is complications (11 hips and 18 knees) for a growing in the treatment of musculoskeletal complication rate of 11.6%. All complications are listed in Tables 2 & 3 (see Appendices) along dissolvable Calcium Sulfate beads have previously with their MSIS-A host grade. A majority of been used in clinical trials, but the results have complications occurred in patients with a grade not been favorable. Among the main problems B or C (MSIS-A) medical host. Eight of the 29 encountered are post-operative wound drainage and complications had wound related complications (3 a toxic reactive synovitis that occurs when beads hips and 5 knees). There were nine failures (3.6%) are placed within a joint. Wound complication in this study. All failures are listed in Tables 4 & rates were reported to be between 25-30% with 5 along with their medical host grade. Six failures several explanations existing for such regular were a result of infection. Excluding the above The predominant thinking infection failures, all remaining patients had a attributes the cause of wound drainage to the normal C-reactive protein when tested between 6 purification processes of "traditional" Calcium and 12 months post-operatively.
Sulfate products. Prior to Stimulan, all Calcium Sulfate products were derived from gypsum harvested from the earth. Various proprietary filtering and wash processes were developed to In this series we used Stimulan as a vehicle to produce medical grade Calcium Sulfate products. deliver a localized dose of antibiotics to an area Despite arduous attempts to derive pure Calcium at risk for infection (i.e. operative wound). This Sulfate products, however is a preliminary study to gauge the effectiveness Additionally, the chemicals used to wash the Reconstructive Review • March 2013 Joint Implant Surgery & Research Foundation
gypsum product still remain within the Calcium bone. This is especially so when endoprosthetic Sulfate. The result is that the product, once hinge devices about the knee are used. Our overall delivered into the human body, is non-physiologic incidence of heterotopic bone in this series was and potentially inflammatory when exposed to the 1.2%. The type of heterotopic bone tended to be synovial fluid environment. In contrast, Stimulan is thin and laminate. In most cases the heterotopic derived from commercially pure, synthetic Calcium bone did not dramatically affect joint function. In Sulfate which is blended via a proprietary process cases of resection arthroplasty where heterotopic to create a product that is considered less "harsh" bone formed, it was easily removed at the time to the synovial joint environment. It was for this of reimplantation. We feel that heterotopic bone reason that this study was undertaken. formation is not a major prohibitive complication for using commercially pure, synthetic antibiotic- In our study, the incidence of wound drainage in loaded Calcium Sulfate dissolvable beads.
revision joint arthroplasty was found to be low. Overall 3.2% of cases experienced wound drainage. A potential drawback to using Calcium Sulfate A majority of the 8 occurrences were found in in revision joint arthroplasty is the potential for medically compromised hosts (MSIS-A Grade B mechanical abrasion of the prosthetic articular or C hosts). Furthermore, wound drainage tended surfaces. The beads within the joint envelope can to present in cases where the volume of beads used migrate and get in between the articular surfaces. was ≥30cc. There are several possible explanations With weight bearing, the beads can get crushed for this occurrence. One explanation is that the and can potentially cause scratching of the articular large volume of beads caused excessive mechanical surfaces. Current work is ongoing in 6 retrieval stretching of the deep soft tissue envelope with Prostalac spacers to look at the articular surfaces joint range, causing the wound to leak. Another for pitting and scratching (Clarke I, McPherson possibility is a chemical effect, as large volumes EJ, Peterson Tribology Laboratory, Loma Linda, of beads could potentially cause a hyperosmotic CA). Maale et al reported using Stimulan beads effect resulting in joint distension and wound loaded with Vancomycin and Tobramycin in single- leakage. A third possible factor is the quality of the stage septic revision total knee arthroplasty. They local tissues and the health of the patient. In the found that the Stimulan beads were soft after revision scenario, soft tissues are often attenuated hydration and do not scratch the joint surface.
from previous surgery and mechanical damage to Even if Calcium Sulfate beads did create scratches the local tissues is commonly encountered. This, or polyethylene pitting, their use for localized combined with poor systemic health (e.g. diabetes, antibiotic delivery in periprosthetic infection or total smoking, prednisone treatment), leads to wound joints at risk for infection still may be preferable. drainage. We believe that wound drainage can be Their use will depend on a case by case risk mitigated by employing modest bead volumes assessment. Long term clinical follow-up is needed (<30cc) combined with surgical techniques which to answer this question more definitively. encourage a water-tight deep soft tissue envelope.
In summary, we find the use of commercially pure, Heterotopic ossification is another potential concern synthetic antibiotic-loaded Calcium Sulfate is an with the use of Calcium Sulfate as a dissolvable acceptable adjuvant treatment tool in revision total pellet. Calcium Sulfate, when used in the intra- hip and total knee arthroplasty. We noted low rates osseous environment, is an osteoconductive of postoperative wound drainage and heterotopic agent. Its application as a bone void filler is well bone formation. In contrast, prior Calcium Sulfate When it is placed within the products derived from processed gypsum have intra-articular environment, the beads are dissolved shown significant problems with wound healing within the synovial fluid and eventually resorbed. Stimulan-antibiotic However, if there is a reduced synovial fluid construct is adaptable, whereby various antibiotic environment (i.e. arthrofibrosis) and exposed intra- formulas can be utilized. Furthermore, this articular bone (from periosteal stripping during localized antibiotic delivery method is relatively surgery) the Calcium Sulfate may have sufficient inexpensive and obviates the need for a second osteoconductive influence to form new periarticular surgery (i.e. removal of PMMA antibiotic beads). Reconstructive Review • March 2013 Initial observations with Stimulan antibiotic beads Table 2 – Knee Complications are encouraging. We will continue to explore and Procedure Case # Volume MSIS-A Complication
research the efficacy of antibiotic-loaded Stimulan Host
beads. Our next phase is to measure local antibiotic concentrations in-vivo in revision joint arthroplasty. Dynamic rotational instability We strive to document and corroborate prior findings by Maale and Eager who showed high local antibiotic concentrations within prosthetic Wound drainage, cellulitis, periprosthetic infection with knee cases. Additionally, we will continue to review wound drainage. I&D with the mechanical effects that Calcium Sulfate beads modular bearing exchange. No have upon the articular surfaces of prosthetic infection at 2-year follow-up.
implants. Finally, we would like to conduct a study Acute knee infection from to examine the potential of improving the results of dental abscess. Failed DECRA. PJI with Stimulan beads via randomized multicenter Implants resected 5 months Arthrofibrosis – knee Table 1 - Results Fall with traumatic arthrotomy. Aseptic Revision TKA
Aseptic Revision THA
I&D and reclosure. No infection at 1-year follow-up. Avg Stimulan/case Avg Stimulan/case Dynamic rotational instability Dynamic rotational instability DECRA TKA
Heterotopic bone formation in medial and lateral gutters. Removed at reimplantation. Avg Stimulan/case Avg Stimulan/case Secondary infection with Candida Albicans. Repeat debridement and spacer Wound drainage. Wound vac applied. Drainage resolved. Superficial wound dehiscence with drainage. Wound revised Resection TKA
Acute renal failure, Creatinine Avg Stimulan/case Avg Stimulan/case 3.6. No dialysis. Acute on chronic renal failure. Dialysis for 3 weeks. Resolved Dynamic rotational instability Reimplantation TKA
Reimplantation THA
Wound drainage, I&D. Recurrent infection. AKA. Avg Stimulan/case 24cc Avg Stimulan/case Wound drainage at 2 weeks post-op. I&D with lavage. Partial small bowel obstruction. Readmitted at 3 weeks post-op for 5 days. No surgery required. Reconstructive Review • March 2013 Joint Implant Surgery & Research Foundation
Table 3 – Hip Complications Table 4 – Knee Failures Procedure Case # Volume MSIS-A Complication
Procedure Case #
Volume MSIS-A Reason for failure
Host
Host
Wound drainage at 3 weeks MRSA infection, extensor post-op. I&D with additional allograft removal, lavage antibiotics beads. Wound debridement. Implant infection at 2 months post-op. infection free at 1 year.
I&D with antibiotics beads. Stable at 1 year. Infection -Staph A. Implants resected for 2 stage protocol.
Implant Bow Mismatch. Distal Femoral crack. No additional surgery. Failed DECRA. Recurrent Hematoma with drainage. I&D with evacuation of the Recurrent patellar hematoma at 2 weeks post-op. subluxation. VMO Advancement procedure at 4 Infection. I&D at 4 weeks months. Stable at 1 year. No post-op. Negative aspiration culture at 6 months post-op. Wound drainage post-op. Table 5 – Hip Failures Malnutrition, albumin 2.1. Recurrent infection at 3 Procedure Case # Volume MSIS-A Reason for failure
months. Hip Resected at 6 Host
DVT Rt. Arm from PICC line Aseptic loosening cup. at 6 weeks post-op. Coumadin Revision to triflange cage. Heterotopic bone formation. Aseptic loosening cup. Removed at reimplantation. Revision to custom triflange Heterotopic bone formation. Removed at reimplantation. Intra-operative hypotension, Recurrent infection. Patient died of concomitant bowel Recurrent dislocation. Revision to constrained New infection hip at 6 months post-operative. Dental infection Strept Wound drainage. Clear serous Viridans. DECRA. Implant fluid. Wound Vac applied for stable at 18 months. Normal Reinfection at 3 months. DECRA procedure. Patient with CLL. Died from blast crisis 6 months after DECRA procedure.
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27. McPherson EJ, Woodson C, Holtom P. Periprosthetic Total Hip Infection: Outcome Using a Staging System. Clinical Orthopaedics and 13. Henry SL, Hood GA, Seligson D. Long-term implantation of Related Research. 2002; 403: 8-15.
gentamicin-polymethylmethacrylate antibiotic beads. Clinical Orthopaedics and Related Research. 1993; 295: 47–53.
28. Miclau T, Dahners LE, Lindsey RW. In vitro pharmacokinetics of antibiotic release from locally implantable materials. Journal of 14. Hunter GA, Welsh RP, et al. The Results of Revision of Total Hip Orthopaedic Research. 1993; 11: 5627–32.
Arthroplasty. JBJS. 1979; 61-B(4): 419-21.
29. Mirzayan R, Panossian V, Avedian R, Forrester DM, Menendez LR. 15. Kanellakopoulou K, Galanopoulos I, et al. Treatment of experimental The use of calcium sulfate in the treatment of benign bone lesions: a Osteomyelitis caused by methicillin-resistant Staphylococcus aureus preliminary report. Journal of Bone and Joint Surgery. 2001; 83: 355- with a synthetic carrier of calcium sulphate (Stimulan) releasing moxifloxacin. International Journal of Antimicrobial Agents. 2009; 33(4): 354-9.
30. Mousset B, Benoit MA, Delloye C, Bouillet R, Gillard J. Biodegradable implants for potential use in bone infection. An in vitro study of 16. Kanellakopoulou K, Panagopoulos P, Giannitsioti E et al. In vitro elution antibiotic-loaded calcium sulfate. International Orthopaedics. 1995; 19: of Daptomycin by a synthetic crystallic semihydrate form of calcium sulfate, Stimulan. Antimicrobial Agents and Chemotherapy. 2009; 53: 31. Nelson CL, Griffin FM, Harrison BH, Cooper RE. In vitro elution characteristics and noncommercially prepared antibiotic PMMA beads. Clinical Orthopaedics and Related Research. 1992; 284: 303–9.
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Joint Implant Surgery & Research Foundation
32. Nelson CL, Hickman SG, Harrison BH. Elution characteristics of gentamicin-PMMA beads after implantation in humans. Orthopedics. 1994; 17: 5415–6.
33. Panagopoulos P, Tsaganos T, Plachouras D et al. In vitro elution of moxifloxacin and fusidic acid by a systhetic crystallic semihydrate form of calcium sulphate (Stimulan™). International Journal of Antimicrobial Agents. 2008; 32(6): 485-7.
34. Papagelopoulos PJ, Mavrogenis AF, Tsiodras S et al. Calcium Sulfate delivery system with Tobramycin for the treatment of chronic Calcaneal Osteomyelitis. The Journal of International Medical Research. 2006; 34: 35. Parker AC, Smith JK, Haggard WO. Evaluation of two sources of Calcium Sulfate for a local drug delivery system: a pilot study. Clinical Orthopaedics and Related Research. 2011; 469(11): 3008-15.
Edward J. McPherson, MD
36. Patzakis MJ, Mazur K, Wilkins J, et al. Septopal beads and autogenous bone grafting for bone defects in patients with chronic osteomyelitis. Clinical Orthopaedics and Related Research. 1993; 295: 112–8.
37. Peltier LF, Bickel EY, Lillo R, et al. The use of plaster of paris to fill defects in bone. Annals of Surgery. 1957; 146: 61-69.
38. Pietrzak WS, Ronk R. Calcium sulfate bone void filler: a review and a look ahead. Journal of Craniofacial Surgery. 2000; 11(4): 327-333. 39. Pulido L, Ghanem E, Joshi A. Periprosthetic Joint Infection, the incidence, timing, and predisposing factors. Clinical Orthopaedics and Related Research. 2008; 466: 1710-15.
40. Robinson D, Alk D, Sandbank J, Farber R, Halperin N. Inflammatory reactions associated with a calcium sulfate bone substitute. Annals of Transplantation. 1999; 4(3-4): 91-97.
My Research Facility 41. Sulo I. The use of gentamicin impregnated plaster beads in the treatment of bone infections. Revue de Chirugie Orthopedique. 1993; 79: 299–305.
42. Toms AD, Davidson D, Masri MA. The Management of Periprosthetic Infection in Total Joint Arthroplasty. The Journal of bone and joint surgery. British volume. 2006; 88(2): 149-155.
43. Tunney MM, Anderson N, et al. Detection of Prosthetic Hip Infection at Revision Arthroplasty by Immunofluorescence Microscopy and PCR Amplification of the Bacterial IGS rNA Gene. Journal of Clinical Microbiology. 1999; 37(10): 3281-90.
44. Turner TM, Urban RM, Gitelis S, Sumner DR, Haggard WO, Parr JE. My Medical Center Antibiotic delivery from calcium sulfate as a synthetic bone graft in a canine defect. Transactions of the Annual Meeting - Orthopaedic Research Society. 1998; 23: 597.
45. Varlet A, Dauchy Ph, Hingrez M. Osteogenetic induction by antibiotic loaded plaster of Paris pellets combined with decalcified bone matrix. Revue de Chirugie Orthopedique. 1985; 71: 73–8.
46. Walenkamp GH, Kleijn LL, de Leeuw M. Osteomyelitis treated with gentamicin-PMMA beads: 100 patients followed for 1–12 years. Acta Orthopaedica Scandinavica. 1998; 69: 5518–22.
As an Orthopaedic surgeon in Los Angeles, 47. Zimmerli W, Trampuz A, Ochsner PE. Current Concepts, Prosthetic Joint CA, I'm grateful to practice medicine in infections (Review Article). The New England Journal of Medicine. 2004; 351: 1645-54.
an area with exceptional healthcare. My choice is to practice at St. Vincent Medical Center. My research is in collaboration with JISRF, Founded here in L.A. in 1971 by Prof. Charles O. Bechtol, MD.
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IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 51, NO. 2, FEBRUARY 2004 Nonlinear Analysis of the Separate Contributions of Autonomic Nervous Systems to Heart Rate Variability Using Principal Dynamic Modes Yuru Zhong, Hengliang Wang, Ki Hwan Ju, Kung-Ming Jan, and Ki H. Chon*, Member, IEEE Abstract—This paper introduces a modified principal dynamic