BIOMECHANICAL EVALUATION OF ORTHOPAEDIC CEMENT COMBINED WITH ANTIBIOTIC AND METHYLENE BLUE

Objective: Acrylic cement has been used for years on orthopaedic surgeries, especially on knee arthroplasties, deserving special attention when added to antibiotics (for treatment of deep bone infections) or stains (to facilitate its removal). The present study was conducted in order to evaluate potential mechanical differences between the orthopaedic cement itself and when this is added to antibiotic and/or stains. Methods: Surgical bone cement Simplex@P Stryker, vancomycin and methylene blue were used, and the mixtures were submitted to physical and mechanical tests according the ABNT NBR ISO 5833 rule. The parameters studied here were: time for mass formation, intrusion capability, resistance to compression, resistance to flexion and maximum temperature reached by the mixtures. Results: The evaluated mixtures were approved as to mass formation, maximum temperature, intrusion capability and resistance to compression. Only the one containing pure cement was approved on the flexion essay. Conclusion: The addition of vancomycin and/or methylene blue to Surgical Simplex@P Stryker bone cement reduces its resistance to flexion, being unacceptable by the ABNT NBR ISO 5833 rule.

Evaluation of exposure index (IgM) in orthopaedic radiography

The exposure index (lgM) obtained from a radiographic image may be a useful feedback indicator to the radiographer about the appropriate exposure level in routine clinical practice. This study aims to evaluate lgM in orthopaedic radiography performed in the standard clinical environment. We analysed the lgM of 267 exposures performed with an AGFA CR system. The mean value of lgM in our sample is 2.14. A significant difference (P=0.000<0.05) from 1.96 lgM reference is shown. Data show that 72% of exposures are above the 1.96 lgM and 42% are above the limit of 2.26. Median values of lgM are above 1.96 and below 2.26 for Speed class (SC) 200 (2.16) and SC400 (2.13). The interquartile range is lower in SC400 than in SC200. Data seem to indicate that lgM values are above the manufacturer’s reference of 1.96. Departmental exposure charts should be optimised to reduce the dose given to patients.

Novel antibiotic-loaded orthopaedic bone cements: insights on drug release profiles and biocompatibility

Acrylic bone cement (BC) is widely used as an anchor of artificial joints. Bacterial infection due to biofilm formation and inflammation are common and difficult to treat problems associated with commercial available BC formulations. Research on novel BC compositions is urgently needed. The main objective of this thesis was to develop a new biocompatible antibiotic-loaded BC with improved release profile. To achieve that aim several additives were incorporated, as an antibiotic (levofloxacin) to combat bacterial growth, an anti-inflammatory drug (diclofenac) to decrease the inflammatory process and two well-known and broadly used biopolymers, alginate and chitosan in order to increase matrix porosity, and in this way to intensify the amount of released drug. Novel BC formulations were tested in order to find the most suitable one that had potential to proceed to clinical application. Numerous tests were conducted as: a) evaluation of drug release profiles in different biomimetic media, b) mechanical and surface studies, c) microbiological activity testing against Staphylococcus aureus and d) in vitro biocompatibility assays (fibroblasts and osteoblasts). In general, the addition of biopolymers increased drug release, didn’t compromised BC mechanical properties and increased BC hydrophilicity. Microbiological testing revealed that Lev[BC]Chi was the only matrix that reduced significantly biofilm formation. On the contrary, alginate and diclofenac loading into BC seemed to increase biofilm growth. Biocompatibility studies showed some decrease in cell viability, in particularly on osteoblasts, mainly due to the high amounts of released drugs. In conclusion, the present work has shown that the matrix with more potential to proceed in further investigations was Lev[BC]Chi. Other conditions (namely additives and drugs concentrations) should be evaluated with the other tested BC matrices before being discharged.

Development of procedures for the design, optimization and manufacturing of customized orthopaedic and trauma implants: Geometrical/anatomical modelling from 3D medical imaging

Tese de Doutoramento (Programa Doutoral em Engenharia Biomédica)

Diagnostic et traitement des infections d'implants orthopédiques [Update on implant related infections in orthopaedic surgery. Diagnosis and treatment]

Infections associated with implants are increasingly important in modem medicine. Biofilms are the cause that these infections are more difficult to diagnose and to cure. Particularly low-grade infections are difficult to distinguish from aseptic failure, because they often present with early loosening and persisting pain. For an accurate diagnosis, clinical signs and symptoms, laboratory markers of infection, microbiology, histology and imaging examinations are needed. The treatment goal is eradication of infection and an optimal functional result. Successful treatment requires adequate surgical procedure combined with long-term antimicrobial therapy, ideally with an agent acting on biofilms.

Le pied à risque: du point de vue de l'orthopédiste [The diabetic foot: the role of the orthopaedic surgeon].

Around 15% of diabetic patients will suffer from a diabetic foot ulcus and subsequent amputation. Prevention and adapted treatment of a foot at risk is important and should be carried out by a multidisciplinary team. A foot at risk needs patient training and adapted footwear. Local wound care and control of vascular status follow. In case of deterioration of the local status surgical debridement and occasionally amputation have to be considered.

The value of serum procalcitonin level for differentiation of infectious from noninfectious causes of fever after orthopaedic surgery.

BACKGROUND: Early diagnosis of postoperative orthopaedic infections is important in order to rapidly initiate adequate antimicrobial therapy. There are currently no reliable diagnostic markers to differentiate infectious from noninfectious causes of postoperative fever. We investigated the value of the serum procalcitonin level in febrile patients after orthopaedic surgery. METHODS: We prospectively evaluated 103 consecutive patients with new onset of fever within ten days after orthopaedic surgery. Fever episodes were classified by two independent investigators who were blinded to procalcitonin results as infectious or noninfectious origin. White blood-cell count, C-reactive protein level, and procalcitonin level were assessed on days 0, 1, and 3 of the postoperative fever. RESULTS: Infection was diagnosed in forty-five (44%) of 103 patients and involved the respiratory tract (eighteen patients), urinary tract (eighteen), joints (four), surgical site (two), bloodstream (two), and soft tissues (one). Unlike C-reactive protein levels and white blood-cell counts, procalcitonin values were significantly higher in patients with infection compared with patients without infection on the day of fever onset (p = 0.04), day 1 (p = 0.07), and day 3 (p = 0.003). Receiver-operating characteristics demonstrated that procalcitonin had the highest diagnostic accuracy, with a value of 0.62, 0.62, and 0.71 on days 0, 1, and 3, respectively. In a multivariate logistic regression analysis, procalcitonin was a significant predictor for postoperative infection on days 0, 1, and 3 of fever with an odds ratio of 2.3 (95% confidence interval, 1.1 to 4.4), 2.3 (95% confidence interval, 1.1 to 5.2), and 3.3 (95% confidence interval, 1.2 to 9.0), respectively. CONCLUSIONS: Serum procalcitonin is a helpful diagnostic marker supporting clinical and microbiological findings for more reliable differentiation of infectious from noninfectious causes of fever after orthopaedic surgery.

Do orthopaedic shoes improve local dynamic stability of gait? An observational study in patients with chronic foot and ankle injuries.

BACKGROUND: Complex foot and ankle fractures, such as calcaneum fractures or Lisfranc dislocations, are often associated with a poor outcome, especially in terms of gait capacity. Indeed, degenerative changes often lead to chronic pain and chronic functional limitations. Prescription footwear represents an important therapeutic tool during the rehabilitation process. Local Dynamic Stability (LDS) is the ability of locomotor system to maintain continuous walking by accommodating small perturbations that occur naturally during walking. Because it reflects the degree of control over the gait, LDS has been advocated as a relevant indicator for evaluating different conditions and pathologies. The aim of this study was to analyze changes in LDS induced by orthopaedic shoes in patients with persistent foot and ankle injuries. We hypothesised that footwear adaptation might help patients to improve gait control, which could lead to higher LDS: METHODS: Twenty-five middle-aged inpatients (5 females, 20 males) participated in the study. They were treated for chronic post-traumatic disabilities following ankle and/or foot fractures in a Swiss rehabilitation clinic. During their stay, included inpatients received orthopaedic shoes with custom-made orthoses (insoles). They performed two 30s walking trials with standard shoes and two 30s trials with orthopaedic shoes. A triaxial motion sensor recorded 3D accelerations at the lower back level. LDS was assessed by computing divergence exponents in the acceleration signals (maximal Lyapunov exponents). Pain was evaluated with Visual Analogue Scale (VAS). LDS and pain differences between the trials with standard shoes and the trials with orthopaedic shoes were assessed. RESULTS: Orthopaedic shoes significantly improved LDS in the three axes (medio-lateral: 10% relative change, paired t-test p < 0.001; vertical: 9%, p = 0.03; antero-posterior: 7%, p = 0.04). A significant decrease in pain level (VAS score -29%) was observed. CONCLUSIONS: Footwear adaptation led to pain relief and to improved foot & ankle proprioception. It is likely that that enhancement allows patients to better control foot placement. As a result, higher dynamic stability has been observed. LDS seems therefore a valuable index that could be used in early evaluation of footwear outcome in clinical settings.

Rehabilitation outcomes for orthopaedic trauma individuals as measured by the INTERMED.

PURPOSE: Bio-psychosocial characteristics of patients after orthopaedic traumas may be a strong predictor of poor outcome. The objective of this prospective study was to assess whether the INTERMED, a measure of bio-psychosocial complexity, identifies complex inpatients during rehabilitation including vocational aspects with a poor outcome 1 year after discharge. METHOD: At entry, the INTERMED scores of 118 inpatients were used to assign patients to the high or low complexity group. A questionnaire evaluated 1 year after discharge whether patients: (1) returned to work, (2) still have therapies, (3) take psychoactive drugs, (4) take medication against pain and (5) were satisfied with vocational therapy. Univariate logistic regressions identified which variables predict INTERMED case complexity during hospitalisation as well as predictors (i.e. INTERMED case complexity, French as preferred language, duration of the disability, accident at work, work qualification, severity of the injury, psychiatric co-morbidities, pain) of the five measured outcomes 1 year after discharge. RESULTS: During hospitalisation, the high complexity group was associated with a high prevalence of psychiatric co-morbidities, a higher level of pain and a weaker perception of treatment effects. One year after discharge, the INTERMED was the sole variable to predict all outcomes. CONCLUSION: The INTERMED identifies complex patients during vocational rehabilitation after orthopaedic trauma and is a good predictor of poor outcome 1 year after discharge.

Modelling the effect of minor orthopaedic day surgery on patient mood at the early post-operative period: a prospective population-based cohort study.

OBJECTIVE: The effect of minor orthopaedic day surgery (MiODS) on patient's mood. METHODS: A prospective population-based cohort study of 148 consecutive patients with age above 18 and less than 65, an American Society of Anaesthesiology (ASA) score of 1, and the requirement of general anaesthesia (GA) were included. The Medical Outcomes Study - Short Form 36 (SF-36), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) were used pre- and post-operatively. RESULTS: The mean physical component score of SF-36 before surgery was 45.3 (SD=+/-10.1) and 8 weeks following surgery was 44.9 (SD=+/-11.04) [n=148, p=0.51, 95% CI=(-1.03 to 1.52)]. For the measurement of the changes in mood using BDI, BAI and SF-36, latent construct modelling was employed to increase validity. The covariance between mood pre- and post-operatively (cov=69.44) corresponded to a correlation coefficient, r=0.88 indicating that patients suffering a greater number of mood symptoms before surgery continue to have a greater number of symptoms following surgery. When the latent mood constructs were permitted to have different means the model fitted well with chi(2) (df=1)=0.86 for which p=0.77, thus the null hypothesis that MiODS has no effect on patient mood was rejected. CONCLUSIONS: MiODS affects patient mood which deteriorates at 8 weeks post-operatively regardless of the pre-operative patient mood state. More importantly patients suffering a greater number of mood symptoms before MiODS continue to have a greater number of symptoms following surgery.

INTERMED predicts non-return to work in an occupational rehabilitation setting for individuals with orthopaedic trauma-Part I

Introduction.- Knowledge of predictors of an unfavourable outcome, e.g. non-return to work after an injury enables to identify patients at risk and to target interventions for modifiable predictors. It has been recently shown that INTERMED; a tool to measure biopsychosocial complexity in four domains (biologic, psychologic, social and care, with a score between 0-60 points) can be useful in this context. The aim of this study was to set up a predictive model for non-return to work using INTERMED in patients in vocational rehabilitation after orthopaedic injury.Patients and methods.- In this longitudinal prospective study, the cohort consisted of 2156 consecutively included inpatients with orthopaedic trauma attending a rehabilitation hospital after a work, traffic or sport related injury. Two years after discharge, a questionnaire regarding return to work was sent (1502 returned their questionnaires). In addition to INTERMED, 18 predictors known at baseline of the rehabilitation were selected based on previous research. A multivariable logistic regression was performed.Results.- In the multivariate model, not-returning to work at 2 years was significantly predicted by the INTERMED: odds-ratio (OR) 1.08 (95% confidence interval, CI [1.06; 1.11]) for a one point increase in scale; by qualified work-status before the injury OR = 0.74, CI (0.54; 0.99), by using French as preferred language OR = 0.60, CI (0.45; 0.80), by upper-extremity injury OR = 1.37, CI (1.03; 1.81), by higher education (> 9 years) OR = 0.74, CI (0.55; 1.00), and by a 10 year increase in age OR = 1.15, CI (1.02; 1.29). The area under the receiver-operator-characteristics curve (ROC)-curve was 0.733 for the full model (INTERMED plus 18 variables).Discussion.- These results confirm that the total score of the INTERMED is a significant predictor for return to work. The full model with 18 predictors combined with the total score of INTERMED has good predictive value. However, the number of variables (19) to measure is high for the use as screening tool in a clinic.