Blood transfusion and venous thromboembolism trends and risk factors in primary and aseptic revision total hip and knee arthroplasties: A nationwide investigation of 736,061 cases.

BACKGROUND: Over the last years, new transfusion guidelines and pharmaceuticals have been introduced in primary and revision total hip and knee arthroplasty (P-THA, P-TKA, R-THA, R-TKA). In the US, a substantial decrease in transfusions has been observed in recent years. Little data exists on the subject in Europe. In this context we aimed to analyze: (1) Is there also a significant decrease in blood transfusion for these procedures in Germany? (2) Which patient and hospital related factors are associated with the risk of blood transfusion? (3) Is there a trend in complications, especially venous thromboembolism and stroke events that can be linked to tranexamic acid use? HYPOTHESIS: There is a significant trend in decreasing blood transfusions in hip and knee arthroplasty. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 736,061 cases treated between January 2011 and December 2017 were included (318,997 P-THAs, 43,780 R-THAs, 338,641 P-TKAs, 34,643 R-TKAs). Multivariable logistic regression was used to model the odds of transfusion as a function of the year of surgery. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: In each cohort the odds of transfusion decreased over time (2017 vs. 2011 (reference): P-THA: OR 0.42 (95%CI: 0.39-0.45), P-TKA: OR 0.41 (95%CI: 0.37-0.46), R-THA: OR 0.52 (95%CI: 0.47-0.58), R-TKA: OR 0.53 (95%CI: 0.46-0.61). Patient-related risk factors for blood transfusion included older age, female gender, lower Body Mass Index, comorbidities such as renal failure, cardiac arrhythmia, congestive heart failure, valvular disease, coagulopathy, depression, and antithrombotic medication prior to surgery. Venous thromboembolism or stroke events did not increase over the study period. DISCUSSION: The incidence of blood transfusions in primary and revision TKA and THA decreased over the study period. This may be due to new transfusion guidelines and the introduction of novel pharmaceuticals such as tranexamic acid. A further improved patient blood management and a focus on vulnerable patient groups might lead to a further future reduction of transfusions, especially in R-THA. LEVEL OF EVIDENCE: III; comparative observational study.

Low Hospital Volume Increases Re-Revision Rate Following Aseptic Revision Total Knee Arthroplasty: An Analysis of 23,644 Cases.

BACKGROUND: Along with rising numbers of primary total knee arthroplasty (TKA), the number of revision total knee arthroplasties (R-TKAs) has been increasing. R-TKA is a complex procedure requiring special instruments, implants, and surgical skills. Therefore it is likely that hospitals with more R-TKAs have more experience with this type of surgery and therefore fewer complications. The purpose of this study is to evaluate the relationship between hospital volume and re-revision rate following R-TKA. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 23,644 aseptic R-TKAs in 21,573 patients treated between January 2013 and December 2017 were analyzed. Outcomes were 90-day mortality, 1-year re-revision rate, and in-house adverse events. The effect of hospital volumes on outcomes were analyzed by means of multivariate logistic regression. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: Hospital volume had a significant effect on 1-year re-revision rate (≤12 R-TKA/a: OR 1.44, CI 1.20-1.72; 13-24 R-TKA/a: OR 1.43, CI 1.20-1.71; 25-52 R-TKA/a: OR 1.13, CI 0.94-1.35; ≥53 R-TKA/a: reference). Ninety-day mortality and major in-house adverse events decreased with increasing volume per year, but after risk adjustment this was not statistically significant. CONCLUSION: We found evidence of higher risk for re-revision surgery in hospitals with fewer than 25 R-TKA per year. It might contribute to improved patient care if complex elective procedures like R-TKA which require experience and a specific logistic background were performed in specialized centers.

Obesity Increases the Risk of Postoperative Complications and Revision Rates Following Primary Total Hip Arthroplasty: An Analysis of 131,576 Total Hip Arthroplasty Cases.

BACKGROUND: The aim of our study is to evaluate the association of body mass index (BMI) and the risk of postoperative complications, mortality, and revision rates following primary total hip arthroplasty given other potentially confounding patient characteristics in a large cohort study. METHODS: Using nationwide billing data for inpatient hospital treatment of the biggest German healthcare insurance, 131,576 total hip arthroplasties in 124,368 patients between January 2012 and December 2014 were included. Outcomes were 90-day mortality, 1-year revision procedures (with and without removal or exchange of implants), 90-day surgical complications, 90-day femoral fractures, and overall complications. The effect of BMI on outcome was analyzed using multivariable logistic regression. Risk-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: BMI had a significant effect on overall complications (30-34 in kg/m2: OR 1.1, CI 1.0-1.2, P = .014; 35-39: OR 1.5, CI 1.3-1.6, P < .001; ≥40: OR 2.1, CI 1.9-2.3, P < .001; <30: reference). The OR for 1-year revision procedures (30-34: OR 1.2, CI 1.1-1.4, P = .001; 35-39: OR 1.6, CI 1.4-1.8, P < .001; ≥40: OR 2.4, CI 2.1-2.7, P < .001; <30: reference) and 90-day surgical complications increased with every BMI category. For mortality and periprosthetic fractures there was a higher risk only for patients with BMI ≥40. CONCLUSION: BMI increases the risk of revision rates in a liner trend. Therefore, the authors believe that patients with a BMI >40 kg/m2 should be sent to obesity medicine physicians in order to decrease the body weight prior elective surgery.

Perthes' or Perthes' resembling disease in 13-month-old boy.

Onset of Perthes' disease is reported frequently from the age of 2 years. Latest publications showed cases with onset of this disease in infancy at ages of 17 and 18 months. We report the case of a 13-month-old boy, who presented with left-sided limping. Radiological examination showed reduced height and fragmentation of the femoral head. Magnetic resonance imaging showed the typical signs of an avascular necrosis. Follow-up was done after 3, 7 and 15 months. Plain radiography showed the femoral head in a state of reparation. This is the youngest documented case of Legg-Calvé-Perthes' disease and is discussed under consideration of the current literature.

Interpretation of surface EMGs in children with cerebral palsy: An initial study using a fuzzy expert system.

Surface EMG detected simultaneously at different muscles has become an important tool for analysing the gait of children with cerebral palsy (CP), as it offers essential information about muscular coordination. However, the interpretation of surface EMG is a difficult task that assumes extensive knowledge and experience. As such, this noninvasive procedure is not frequently used in the general clinical routine. An Artificial Intelligence (AI) system for interpreting surface EMG signals and the resulting muscular coordination patterns could overcome these limitations. To support such interpretation, an expert system based on fuzzy inference methodology was developed. The knowledge-base of the system implemented 15 rules, from which the fuzzy inference methodology performs a prediction of the effectiveness of the muscular coordination during gait. Our aim was to assess the feasibility and value of such an expert system in clinical applications. Surface EMG signals were recorded from the tibialis anterior, soleus muscle, and gastrocnemius muscles of children with CP to assess muscular coordination patterns of ankle movement during gait. Nineteen children underwent 114 surface EMG measurements. Simultaneously, the gait cycles of each patient were determined using foot switches and videotapes. From the EMG signals, the effectiveness of the ankle movement was predicted by the expert system, and predictions were classified using a three-point ordinal scale. In 91 cases (80%), the clinical findings matched the predictions of the expert system. In 23 cases (20%) the predictions of the expert system differed from the clinical findings with 12 cases revealing worse and 11 cases revealing better results in comparison to the clinical findings. As this study is a first attempt to verify the feasibility and correctness of this expert system, the results are promising. Further study is required to assess the correlation with the kinematic data and to include the whole leg.

Efficacy of topical diclofenac diethylamine gel in osteoarthritis of the knee.

OBJECTIVE: To assess the efficacy and safety of topical diclofenac diethylamine gel, 1.16%, 4 g applied qid for 3 weeks to relieve the symptoms of osteoarthritis (OA) of the knee. METHODS: Patients with OA of the knee washed out their OA medications for at least 5 drug half-lives. Patients with adequately high baseline pain scores were randomized to apply either double-blind active or placebo gel for 3 weeks. Acetaminophen (up to 2 g/day) was supplied as rescue medication. In a diary, patients recorded compliance to dosing and use of rescue medication and assessed daily pain on movement, spontaneous pain, and pain relief. At weekly site visits, patients completed the Western Ontario and McMaster (WOMAC) Osteoarthritis Index Questionnaire, which includes assessment of pain, stiffness, and physical function, and assessed pain intensity "right now." At the final visit, a global assessment of treatment efficacy was completed. RESULTS: Of 238 randomized patients, 237 were included in the intent to treat efficacy analysis. Treatments differed significantly for daily pain on movement at Day 5, and continued on most days through end of study. Peak differences were achieved in the second week. On the primary outcome, average pain on movement over Days 1-14, diclofenac gel was significantly superior to placebo gel. Scores for all 3 WOMAC indices for diclofenac gel treatment were significantly superior to placebo at Weeks 2 and 3. A significant difference was achieved on pain intensity "right now" at all 3 weeks. At the end of the study, patients rated diclofenac gel as significantly more effective in treating the pain of OA of the knee (p = 0.03) compared to placebo. There were no safety issues concerning adverse events or laboratory values. CONCLUSION: Diclofenac gel was effective and safe for relief of symptoms of OA of the knee over 3 weeks of dosing.

Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest.

STUDY DESIGN: A prospective, controlled, open, randomized multicenter study. OBJECTIVE: The study's objective was to demonstrate equivalence of a novel, moldable, resorbable, and degradable synthetic polymer (Bone Seal) compared with a collagen fleece (Lyostypt) in efficacy and safety for topical hemostasis after iliac crest bone graft harvesting. SUMMARY OF BACKGROUND DATA: Harvesting cortico-cancellous bone from the iliac crest is a well established procedure in orthopedic and particularly in spine surgery. It is associated with significant morbidity at the donor site where hematoma formation may cause impaired wound healing and infections in up to 10% of cases. METHODS: A total of 112 patients were included in the safety analysis. Safety was determined by a compound wound healing score and the incidence of adverse clinical effects. One hundred and eight patients were studied for equivalence in efficacy using a compound bleeding score. The handling properties and the application to the bone surface of either device were measured with two additional compound scores. RESULTS: The mean bleeding scores in the final analysis was 4.5 +/- 1.3 for the Bone Seal group and 4.2 +/- 1.3 for the collagen fleece group. Bone Seal was better applicable to the bleeding bone surfaces than the collagen fleece, even though its handling was more complicated. Wound healing and the incidences of adverse clinical events were comparable in either study group. CONCLUSIONS: Bone Seal is an effective and safe hemostatic material for sealing bleeding bone surfaces after iliac crest bone graft harvesting. By virtue of its hemostatic efficacy, Bone Seal is preventive for wound healing disorders.

The effect of basic fibroblast growth factor on bone regeneration when released from a novel in situ setting tricalcium phosphate cement.

The osteostimulative effect of the basic fibroblast growth factor is well known, but it is dose dependent, and release kinetic depends on interactions with the used carrier. The aim of our study was to determine the osteostimulative effect of a composite, consisting of an in situ setting tricalcium phosphate cement and basic fibroblast growth factor. A trepanation defect of 1.5 mm in the femur diaphysis of Sprague-Dawley rats was filled with the in situ setting TCP cement combined with 0, 0.25, 2.5, or 25 microg rh bFGF, an autologous bone graft or left empty. The rats were euthanized after 1 and 3 weeks and examined by radiography, histology, histomorphometry, and bending test. The data were analyzed by the Wilcoxon and Kruskal-Wallis test. All TCP groups with or without bFGF showed a good bony ingrowth with a close bone-cement contact. Osseous ingrowth was not influenced by the addition of the different doses of bFGF as shown by histomorphometry. Also, mechanical strength was not affected. In conclusion, the combination of this in situ setting cement with bFGF is not useful for clinical application. The reason of these negative results remains unclear: the osteostimulative effect of bFGF is well known, and the TCP-cement was used as a carrier for rhBMP-2 successfully. These negative results may be due to a too slow or too fast release of bFGF from the cement.

Surface pretreatments for medical application of adhesion.

Medical implants and prostheses (artificial hips, tendono- and ligament plasties) usually are multi-component systems that may be machined from one of three material classes: metals, plastics and ceramics. Typically, the body-sided bonding element is bone. The purpose of this contribution is to describe developments carried out to optimize the techniques, connecting prosthesis to bone, to be joined by an adhesive bone cement at their interface. Although bonding of organic polymers to inorganic or organic surfaces and to bone has a long history, there remains a serious obstacle in realizing long-term high-bonding strengths in the in vivo body environment of ever present high humidity. Therefore, different pretreatments, individually adapted to the actual combination of materials, are needed to assure long term adhesive strength and stability against hydrolysis. This pretreatment for metal alloys may be silica layering; for PE-plastics, a specific plasma activation; and for bone, amphiphilic layering systems such that the hydrophilic properties of bone become better adapted to the hydrophobic properties of the bone cement. Amphiphilic layering systems are related to those developed in dentistry for dentine bonding. Specific pretreatment can significantly increase bond strengths, particularly after long term immersion in water under conditions similar to those in the human body. The bond strength between bone and plastic for example can be increased by a factor approaching 50 (pealing work increasing from 30 N/m to 1500 N/m). This review article summarizes the multi-disciplined subject of adhesion and adhesives, considering the technology involved in the formation and mechanical performance of adhesives joints inside the human body.

Stimulation of bone formation with an in situ setting tricalcium phosphate/rhBMP-2 composite in rats.

The aim of the study was to determine bone-regenerative effects of an in situ setting tricalcium phosphate (TCP) cement combined with rhBMP-2 and to compare it with autologous bone graft. A trepanation defect of 1.5 mm in the femur diaphysis of Sprague-Dawley rats was filled with an in situ setting TCP cement combined with 0, 0.25, 2.5, or 25 microg of rhBMP-2, an autologous bone graft, or left empty. The rats were euthanized after 1 and 3 weeks and examined by radiography, histology, histomorphometry, and bending tests. All TCP groups with or without BMP-2 showed a good bony ingrowth with a close bone-cement contact. Histomorphometric analysis showed no increase of new bone formation in the defect, but a dose-dependent increase in callus formation with a maximum at 25 microg of rhBMP-2. As shown with intravital fluorochrome staining, new bone formation started earlier using rhBMP-2. Bone strength, measured in a three-point bending test and expressed in percentage of the contralateral healthy femur, was 75% for TCP + 25 microg rhBMP-2, 44% for TCP + 2.5 microg rhBMP-2, and 34% for autologous bone graft. TCP particles were detectable in all groups after 3 weeks. Callus formation and bending strength of the TCP + 25 microg rhBMP-2 group was superior to autologous bone graft. So TCP/rhBMP-2 composites may prove to be an effective substitute for autologous bone grafts.