Rapid study assessment in follow-up whole-body computed tomography in patients with multiple myeloma using a dedicated bone subtraction software.

OBJECTIVES: The diagnostic reading of follow-up low-dose whole-body computed tomography (WBCT) examinations in patients with multiple myeloma (MM) is a demanding process. This study aimed to evaluate the diagnostic accuracy and benefit of a novel software program providing rapid-subtraction maps for bone lesion change detection. METHODS: Sixty patients (66 years ± 10 years) receiving 120 WBCT examinations for follow-up evaluation of MM bone disease were identified from our imaging archive. The median follow-up time was 292 days (range 200-641 days). Subtraction maps were calculated from 2-mm CT images using a nonlinear deformation algorithm. Reading time, correctly assessed lesions, and disease classification were compared to a standard reading software program. De novo clinical reading by a senior radiologist served as the reference standard. Statistics included Wilcoxon rank-sum test, Cohen's kappa coefficient, and calculation of sensitivity, specificity, positive/negative predictive value, and accuracy. RESULTS: Calculation time for subtraction maps was 84 s ± 24 s. Both readers reported exams faster using subtraction maps (reader A, 438 s ± 133 s; reader B, 1049 s ± 438 s) compared to PACS software (reader A, 534 s ± 156 s; reader B, 1486 s ± 587 s; p < 0.01). The course of disease was correctly classified by both methods in all patients. Sensitivity for lesion detection in subtraction maps/conventional reading was 92%/80% for reader A and 88%/76% for reader B. Specificity was 98%/100% for reader A and 95%/96% for reader B. CONCLUSION: A software program for the rapid-subtraction map calculation of follow-up WBCT scans has been successfully tested and seems suited for application in clinical routine. Subtraction maps significantly facilitated reading of WBCTs by reducing reading time and increasing sensitivity. KEY POINTS: • A novel algorithm has been successfully applied to generate motion-corrected bone subtraction maps of whole-body low-dose CT scans in less than 2 min. • Motion-corrected bone subtraction maps significantly facilitate the reading of follow-up whole-body low-dose CT scans in multiple myeloma by reducing reading time and increasing sensitivity.

Revised histopathological consensus classification of joint implant related pathology.

This extended classification of joint implant related pathology is a practical histopathologic classification based on defined morphological criteria covering the complete spectrum of pathohistologic changes in periprosthetic tissues. These changes may occur as a consequence of endoprosthetic replacement of large joints and may lead to a reduction in the prosthesis survival rate. We describe the established consensus classification of the periprosthetic membrane, in which aseptic and septic prosthetic loosening can be subdivided into four histological types, as well as histopathological criteria for additional significant pathologies including endoprosthetic-associated arthrofibrosis, particle-induced immunological, inflammatory and toxic mechanisms (adverse reactions), and bone tissue pathologies. These characteristic tissue alterations and their relationships are summarized in the extended classification. Since particle heterogeneity in periprosthetic tissue is high and particle identification is a necessary part of diagnosis, the identification of different types of particles is described in the histopathological particle algorithm. The morphological qualities of prosthetic material particles and the demarcation between abrasion and non-abrasion endogenous particles are also summarized. This feasible classification which is based on low cost standard tissue processing and examination and on well-defined diagnostic criteria is a solid platform for the histological diagnosis of implant associated pathologies providing a stable and reproducible tool for the surgical pathologist. Since this classification is suitable for standardized histopathological diagnostics, it might also provide a useful data set for joint arthroplasty registers, particularly for registers based on so-called routine data.

[Revised consensus classification. Histopathological classification of diseases associated with joint endoprostheses]. / Erweiterte Konsensusklassifikation. Histopathologische Klassifikation von Gelenkendoprothesen-assoziierten Erkrankungen.

The revised classification of the periprosthetic membrane (synovial-like interface membrane SLIM) encompasses all pathological alterations which can occur as a result of endoprosthetic replacement of major joints and lead to a reduction in durability of prostheses. This also includes the established consensus classification of SLIM by which aseptic and septic prosthetic loosening can be subdivided into four histological types and histopathological criteria for additional pathologies: endoprosthesis-associated arthrofibrosis, immunological/allergic alterations and osseous pathologies. This revision represents the foundation for the histopathological diagnostics of the total spectrum of diseases associated with joint prostheses, is a suitable basis for a standardized diagnostic procedure and etiological clarification of endoprosthesis failure and also as a data standard for endprosthesis registers, in particular for registers based on routine data (e.g. German endoprosthesis register).

[Registration procedure for incidents with implants]. / Meldeverfahren bei Vorkommnissen mit Implantaten.

Incidents involving implants, whether there is a break in the osteosynthesis plate or a synthetic inlay of an endoprosthesis, are incidents with mostly severe repercussions for the patient with immediate and delayed effects for the clinic involved and the manufacturer.

[Joint endoprosthesis pathology. Histopathological diagnostics and classification]. / Gelenkendoprothesenpathologie. Histopathologische Diagnostik und Klassifikation.

Prosthesis durability has steadily increased with high 10-year rates of 88-95%. However, four pathogenetic groups of diseases can decrease prosthesis durability: (1) periprosthetic wear particle disease (aseptic loosening) (2) bacterial infection (septic loosening) (3) periprosthetic ossification, and (4) arthrofibrosis. The histopathological "extended consensus classification of periprosthetic membranes" includes four types of membranes, arthrofibrosis, and osseous diseases of endoprosthetics: The four types of neosynovia are: wear particle-induced type (type I), mean prosthesis durability (MPD) in years 12.0; infectious type (type II), MPD 2.5; combined type (type III) MPD 4.2; and indeterminate type (type IV), MPD 5.5. Arthrofibrosis can be determined in three grades: grade 1 needs clinical information to be differentiated from a type IV membrane, and grades 2 & 3 can be diagnosed histopathologically. Periprosthetic ossification, osteopenia-induced fractures, and aseptic osteonecrosis can be histopathologically diagnosed safely with clinical information. The extended consensus classification of periprosthetic membranes may be a diagnostic groundwork for a future national endoprosthesis register.

The effect of Palamed G bone cement on early migration of tibial components in total knee arthroplasty.

OBJECTIVE: Migration of the tibial component in total knee arthroplasty (TKA) is subject of many studies using roentgen stereophotogrammetric analysis (RSA). In previous studies of cemented and uncemented tibial components, high migration values were found. Improvements in cementing technique, prosthetic design and pre-coating techniques reduced these values as shown in more recent studies. MATERIAL AND SUBJECTS: A total of 35 patients were initially included in the study and operated on between 12/1999 and 10/2000. All patients received a NexGen TKA cemented into the proximal tibia using Palamed G bone cement. The implants and the tibial metaphysis were marked with standard tantalum markers. Radiostereometric analysis was performed post-operatively and after 3, 6 and 12 months using a standard digital radiostereometric analysis. Functional parameters were assessed using the Knee Society Score (KSS) clinical rating system. RESULTS: There were no complications and failures within the first year. After 1 year radiostereometric measurements of the translational parameters along and the rotational parameters around the x-, y- and z-axis revealed: X-Trans -0.19 mm, Y-Trans +0.02 mm, Z-Trans +0.08 mm, X-Rot +0.26 degrees, Y-Rot -0.35 degrees, Z-Rot +0.09 degrees. The maximum total point motion was +0.96 mm and the mean maximum subsidence was -0.23 mm. Except for anterior-posterior, medio-lateral stability and extension leg all endpoints of the KSS clinical rating system showed a significant improvement. CONCLUSIONS: After 12 months, the use of Palamed G bone cement in total knee arthroplasty was demonstrated to be safe. Both the clinical and radiostereometric results were good and comparable to the results reported in other RSA studies in cemented total knee arthroplasty.

[DRG based development of revenues in orthopaedic surgery. A comparison on the development of cost weights and average lengths of hospital stay in Germany (G-DRG V1.0) and in Australian teaching hospitals (AR-DRG 4.1)]. / DRG-basierte Erlösentwicklung in der Orthopädischen Chirurgie. Die vergleichende Entwicklung der Relativgewichte und Patientenverweildauern in Deutschland (aktueller G-DRG V1.0) und in australischen Lehrkrankenhäusern (AR-DRG 4.1) am Beispiel Endoprothetik, Wirbelsäulen-, Schulter- und Fusschirurgie.

STUDY GOAL: In September 2002 the Federal Ministry of Health (BMG) has passed a decree in respect to the diagnosis related group system (G-DRG) for German hospitals (KFPV). From 2003 on the basis of this decree German hospitals were offered for the first time to use the G-DRG system optionally according to the " Section 17b Abs.4 of the Hospital Financing Law (Krankenhausfinanzierungsgesetz-KHG)". In addition the preliminary calculation data for the German DRG-System were published. The goal of this study was to compare the development of the cost weights and the average lengths of hospital stay in Australian teaching hospitals between 1998 and 2001 with the cost weights and average lengths of hospital stay in German hospitals according to the data published in the first German calculation (G-DRG V1.0). METHODS: An analysis was performed using the publically accessible reports on the national hospital cost data collections from 1998 until 2001 as they were published by the Commonwealth Department of Health and Aged Care in Australia. These data were compared with the cost weight calculation and average lengths of hospital stay calculation of the Institute for the Assessment of Cost Weights (InEK GmbH) published in the G-DRG V1.0 version. RESULTS: From 1998 until 2001 the cost weights of medical procedures such as spine fusion operations and joint arthroplasty revision operations on the hip and on the knee with severe complications and co-morbidities increased continuously. This development was not seen in DRG's without complications and co-morbidities, in food and ankle procedures and in shoulder procedures. The average length of hospital stay decreased continuously with very few exceptions. The average length of stay for so called C-DRG's (I09, I12, I13, I68, I69, I71, I75, I76) and in particular so called Z-DRG's (I16-I27) are in general longer by a factor of at least 2 in German hospitals when compared to Australian hospitals. CONCLUSION: A high quality of right-coding of ICD and ICPM Codes is a prerequisite to reach the correct revenue-relevant DRG. In Germany the average length of hospital stay is significantly longer than in Australia. In general the MDC-8-DRG's have demonstrated a smaller range when compared with the first calculated German DRG's in respect to the complexity of the procedures. Future management of the expected reductions in hospital stay will be based on a continuous co-operative efforts to improve the structural-, process- and (clinical guidelines and clinical pathways) and outcome quality of our medical procedures. The central objective of this effort is the well-being of our patients.

[Effect of rotation of the femoral and tibial components on patellofemoral malalignment in knee arthroplasty]. / Der Einfluss der Femur- und Tibiakomponentenrotation auf das patellofemorale Versagen beim künstlichen Kniegelenkersatz.

Patellofemoral complications are among the most common causes for revision surgery in total knee arthroplasty. So far no quantitative assessment has been made of the femoral and tibial malalignment or the positioning of the patellar component and the type of patellofemoral complication or failure. In particular, no comparative studies are available that include patients with and without patellofemoral failure in respect to the above-mentioned parameters when implant material, implant design, and fixation technique were identical. Between 1985 and 1992, 171 MG I total knee arthroplasties were performed. Since 1999, 20% of all the implanted MG I knee arthroplasties (all with metal-backed patellar component) had to be revised. Of those 34 patients, 18 were pair matched with 18 control patients based on the criteria of sex, body mass index, and age. The only difference in the control group was that they did not suffer any malfunction of the patellofemoral mechanism. To assess the patella component localization, conventional AP radiographs, patellar merchant view radiographs in 30 degrees, and CT scans were performed. This study has demonstrated a significant difference for the thickness of the patellar component and a trend regarding the rotational malalignment of the tibial component. Potential causes for the malrotation and guidelines to prevent rotational malalignment are discussed.

[What effect does the hydroxyapatite coating have in cementless knee arthroplasty?]. / Welchen Effekt hat die Hydroxylapatitbeschichtung beim zementfreien Kniegelenkersatz? Eine prospektiv randomisierte RSA-Langzeitstudie über 9 Jahre.

The goal of this study was to compare the migration of noncemented diffusion sintered titanium fibermesh-coated tibial components with (HA group) and without (non-HA group) additional hydroxyapatite coating. For this purpose digital radiostereometry (DIRSA) was used to compare the migration after 2 and 9 years for the two groups. After 2 years the mean maximum subsidence of the HA-coated components (0.24+/-0.18 mm) was about one-half of the mean maximum subsidence of the non-HA-coated group (0.55+/-0.55 mm). After 9 years the maximum subsidence of the HA-coated components was still smaller, but not as pronounced as before. The same trend was also found for the endpoint maximum total point motion (MTPM). After 2 years the mean MTPM of the HA-coated components was 0.66+/-0.38 mm and of the non-HA group 0.73+/-0.50 mm. After 9 years the mean MTPM for the HA-coated components was 0.54+/-0.15 mm and for the non-HA-coated components 0.74+/-0.20 mm. None of the HA-coated tibial components but one of the non-HA group had to be revised and exchanged due to aseptic loosening.

Cell differentiation under the influence of rh-BMP-2.

Bioactive bone growth factors will likely play an important role in the regeneration of bone. BMP-2 is known to promote osteoblastic cell differentiation and osteogenesis. Whether the BMPs act on human osteoblastic cells by increasing immature cell growth and/or differentiation is unknown. The goal of this study was to analyse possible effects of rhBMP-2 on cell differentiation using a human bone marrow cell culture. rhBMP-2 was added to the culture medium once. Fourteen days after addition of rhBMP-2 the cells were incubated with monoclonal antibodies. The cells were counted and analysed in a fluorescence-activating cell sorter (FACS). Compared to the controls there was an increasing effect on granulocytes, B cells and stem cells. The T-cells and monocytes show no increase or decrease after rhBMP-2 treatment.

Missing osteoconductive effect of a resorbable PEO/PBT copolymer in human bone defects: a clinically relevant pilot study with contrary results to previous animal studies.

PEO/PBT 70/30 (POLYACTIVE(R) 70/30), a degradable porous copolymer with elastic properties, was found to be osteoconductive in many animal studies. The aim of this study was to determine the osteoconductive effect in a human paired control iliac defect model. In seven patients undergoing anterior spinal interbody fusion surgery, two bicortical iliac defects for autograft harvesting were created. The defect size was identical for both defects measuring about 40 x 15 mm (group I). One defect was filled with the degradable implants, whereas the remaining one was left untreated as a control. The defect site for treatment was chosen randomly. In three further patients, only one defect measuring about 40 x 35 mm was created (group II). All patients were examined clinically and radiologically by spiral-CT after 1, 6, 12, 24, and 52 weeks. Three-dimensional reconstructions as well as CT-volumetric measurements using 1 mm sections were used as evaluation methods. In group I, a two-tailed paired t-test showed that the treated defects had significantly less formation of new bone than the untreated ones (p < 0.05 after 12 weeks, p < 0.01 after 52 weeks). Also, in group II, not much bone ingrowth could be observed. The histological evaluation of one patient in group I revealed no bone within the pores, and a fibrous layer between bone and implant was always present. Therefore, PEO/PBT 70/30 cannot be recommended as a bone substitute for clinical use. Differences in bone regeneration between humans and certain animal species as well as inapplicable defect models in previous animal studies are discussed as possible reasons for the failure.

[A scale for measuring symptoms related to degenerative diseases of the cervical spine. A reference in determining indications and evaluating surgical outcome]. / Eine Skala zur Messung von Beschwerden bei degenerativen Veränderungen der Halswirbelsäule (HWS). Hilfe zur Indikationsstellung und zur Evaluation des Operationserfolgs.

A scale for measuring symptoms related to degenerative diseases of the cervical spine is presented. Twenty typical symptoms are listed, e. g., neck pain, dysesthesia, and reduced mobility. Responses are assessed via a 6-point scaling ("did not have symptom" - "had symptom and suffered very strongly".) The cervical spine scale was tested in three samples: patients having undergone cervical spine surgery (n = 70), patients with other orthopedic diagnoses (n = 104), and healthy students (n = 100). The single items of the scale were aggregated into four scores: total number of symptoms, degree of overall symptom distress, functional disability, and pain/psychological distress. Statistical analyses proved the high reliability (Cronbach's alpha = 0.85 to 0.95) and validity (content, convergent, discriminant) of all scores. The scale differs clearly between cervical spine patients, other orthopedic patients and healthy individuals, and between cervical spine patients with different subjective operative outcomes. For applied clinical purposes the cervical spine scale can be included in a quality of life profile (QL-profile); this allows for a readily understandable graphic depiction of individual patients' QL-status.

Prevention of heterotopic bone formation after total hip arthroplasty: a prospective randomised study comparing postoperative radiation therapy with indomethacin medication.

Heterotopic ossification (HO) after total hip arthroplasty is known to be a major complication with an impact on the functional outcome. Efforts have been made to prevent the occurrence of HO by means of either radiation therapy or pharmacotherapy. To date, there are no data available regarding the relative benefit of radiation versus medication with non-steroidal anti-inflammatory drugs. The objective of this study was to compare single-dose 600-cGy radiation therapy with indomethacin medication for their effect on the prevention of heterotopic bone formation after total hip arthroplasty. In all, 154 patients were included in the study. All patients underwent primary total hip arthroplasty due to osteoarthritis. Patients were randomly assigned to three different therapeutic groups. (a) The radiation group received a single radiation dose of 600 cGy between the 2nd and 4th postoperative day. (b) The indomethacin group received an oral application of indomethacin 2 x 50 mg per day from the 1st to 42nd postoperative day. (c) The control group received neither radiation nor indomethacin medication. There were significant group differences (P < 0.001). A least significant difference test (LSD) revealed that the mean of the control group was significantly different from that of the radiation and indomethacin groups. The 13 patients (8.4%) classified Brooker 3 or 4 were all in the control group. Again, this effect was statistically significant (chi-square, P < 0.001). In conclusion, this study demonstrated that both radiation and indomethacin therapy are effective in the prevention of postoperative HO. The choice for either one of the treatments has to be based on availability, contraindications, side-effects, practicability, standardisation and cost. Based on these considerations together with the results of this study, we currently use postoperative radiation with 600 cGy for all patients undergoing primary total hip arthroplasty.

Implant fixation by bone ingrowth.

The term osseointegration referred originally to an intimate contact of bone tissue with the surface of a titanium implant; the term bone ingrowth refers to bone formation within an irregular (beads, wire mesh, casting voids, cut grooves) surface of an implant. The section dealing with the historical background describes the development of macroporous, microporous, and textured surfaces with an emphasis on the evolution of porous and textured metal surfaces. The principal requirements for osseointegration and bone ingrowth are systematically reviewed as follows: i) the physiology of osseointegration and bone ingrowth, including biomaterial biocompatibility with respect to cellular and matrix response at the interface; ii) the implant surface geometry characteristics; iii) implant micromotion and fixation modes; and iv) the implant-bone interface distances. Based on current methods of bone ingrowth assessment, this article comparatively reviews and discusses the results of experimental studies with the objective of determining local and systemic factors that enhance bone ingrowth fixation.

Human bone marrow cell culture: a sensitive method for determination of the biocompatibility of implant materials.

The objective of this study was to develop a test method for determining the cytotoxicity and biocompatibility of various biomaterials that are used in orthopaedic surgery. This method is based on the use of a human bone marrow cell culture and was developed as an alternative to animal experiments. Human bone marrow cell culture has certain advantages over other cell culture models, as its results show a greater conformity with animal experimental results and clinical studies. Primary cell adherence, cell number, cell proliferation, production of extracellular matrix, cell viability and cell differentiation were used as indicative parameters of biocompatibility. After 2 weeks in culture, differences could be observed between the biomaterials with respect to these parameters. Cell numbers were greatest on the hydroxyapatite ceramic specimens, but were decreased on the titanium alloy specimens. Extracellular matrix hydroxyapatite production was high for ceramics, but reduced for titanium specimens. The polymers allowed only a few cells to adhere, and there were no signs of extracellular matrix production. The influence of biomaterials on differentiation of large numbers of cells was analysed by using flow cytophotometry. There were similar populations of T cells and monocytes on all specimens. However, extended B cell and granulocyte populations were observed with titanium and polyethylene.

Biocompatibility analysis of different biomaterials in human bone marrow cell cultures.

A cell culture system for biocompatibility testing of hip implant materials is described. Human bone marrow cells have been chosen because these cells are in direct contact with the biomaterial after implantation in situ. The sensitivity of this method is evaluated for materials which are already being used as implants in humans and animal, e.g., hydroxyapatite (HA) ceramic, pure titanium, and ultra-high-molecular-weight polyethylene (UHMWPE). As indicative parameters of biocompatibility primary cell adherence, cell number, cell proliferation, production of extracellular matrix, cell vitality, and cell differentiation are described. After 2 weeks in culture, obvious differences between the biomaterials with respect to the indicative parameters could be observed. Cell numbers were greatest on the HA specimens. In the case of titanium alloys, we observed a decreased number of cells. The production of extracellular matrix was high for the HA ceramics but reduced for titanium specimens. The polymers allowed only a few adherent cells and showed no signs of extracellular matrix production. The results can be correlated astonishingly well to animal experiments and clinical experiences. Therefore, we suggest that this cell culture system seems to be a useful tool for biocompatibility testing of bone implantation materials. It also helps reduce animal experiments. With the help of flow cytophotometry, we analyzed the influence of biomaterials on large numbers of cells with respect to differentiation. There were similar populations of T cells and monocytes on all specimens tested. Extended B-cell and granulocyte populations, however, were observed with titanium and UHMWPE. Most osteocalcin-containing cells adhered to the HA ceramics.

Recombinant and nonrecombinant factor XIII and its effect on bone ingrowth and strength of fixation.

Thirty cylindrical, commercially pure, titanium fiber, porous-coated Ti6Al4V implants were inserted press-fit into the proximal humeral portion of 30 sheep humeri to determine the systemic effect of recombinant factor XIII and placenta-derived factor XIII concentrate on bone ingrowth and strength of fixation. For both the recombinant factor XIII and the factor XIII concentrate group, the volume of bone ingrowth and the strength of fixation were higher than for the control specimens. However, the difference was only significant for the factor XIII concentrate group.

Standardized evaluation of long-term results after anterior lumbar interbody fusion.

A total of 113 patients, excluding those with tumor, spondylitis, and idiopathic scoliosis, underwent anterior lumbar interbody fusion (ALIF) with autologous iliac crest graft between 1984 and 1991 at our department. The proportion of these who were failed back patients was higher than that reported in the literature. Evaluation of functional outcome was feasible in 80 patients, utilizing Oswestry and Marburg scores, which were closely intercorrelated. The overall results yielded an improvement in the Oswestry score of 35.7 percentage points. A subset of 52 patients who were evaluated twice, showed the same results at an average of 6.6 years as they did at 2.3 years following surgery. Functional results showed a weak correlation with postoperative height loss of the intervertebral space. Influencing factors for the functional result were: postoperative compensation claim, age, and obesity. Of the professional people involved, 19.4% did not return to any occupation. Patients satisfied with the result had significantly greater functional improvement. Younger patients with additional dorsal distraction prior to ALIF for reduction of severe spondylolisthesis fared better than patients with ALIF alone. The rate of complications was low and did not contribute to the postoperative functional result. On the basis of these results further prospective studies have been designed and are currently underway.