Outcome determinants for coronal shear fractures of the distal humerus.

PURPOSE: Coronal shear fractures of the distal humerus involving the capitellum and trochlea are rare injuries. Internal fixation with headless compression screws provides a stable construct facilitating early mobilisation. Our study aimed to identify the key determinants of both radiological and functional outcomes of patients with distal humerus coronal shear fractures treated with internal fixation. METHODS: A retrospective analysis of 61 patients with distal humerus coronal shear fractures who were treated surgically was done. Demographics, fracture morphology, time to surgery, operative details such as surgical approach and implant used, quality of reduction, time to union, and associated complications from hospital records. Radiological outcomes were assessed using plain radiographs, and the functional outcomes were by Oxford Elbow Score (OES) and Mayo Elbow Performance Index (MEPI). RESULTS: Patients with anatomical reduction of the fracture had better functional outcomes and range of motion. The presence of posterior comminution of capitellum resulted in poorer outcomes (p = 0.03). Delayed presentation did not alter the outcome when the anatomical reduction was achieved. Myositis ossificans was noted in nine patients and non-union in five patients. Two patients developed avascular necrosis of the capitellum and arthritis of the elbow joint. CONCLUSION: Anatomical reduction and posterior comminution are the two key determinants of the functional outcome in these coronal shear fractures of the distal humerus. Early mobilisation following a stable fixation is crucial in achieving a good outcome.

Management of slipped capital femoral epiphysis: Results of a survey of the members of the Paediatric Orthopaedic Society of India (POSI).

AIM: To determine the preferred practices in the treatment of slipped capital femoral epiphysis (SCFE) among members of the Paediatric Orthopaedic Society of India (POSI). MATERIALS AND METHODS: A questionnaire with 16 vignettes was made about SCFE and sent to all members of the Paediatric Orthopaedic Society of India (POSI) to study the similarity and variation in the management of SCFE. Specifically, respondents were asked about the role of reduction, methods of fixation, prophylactic fixation of the non-affected hip, postoperative management and their view on the prevalence of Femoro Acetabular Impingement (FAI) and anticipated need for secondary surgery. RESULTS: The response rate was 94 out of 203 members of Paediatric Orthopaedic Surgeons of India (51.9%). 62 out of 94 (66%) participating surgeons had an exclusive paediatric orthopaedics workload, with 61 surgeons (65%) having more than ten years of experience. Seventy-eight surgeons (83%) were most consistent in their advice for the management of stable slips based on severity. For severe stable slips, 67 surgeons (71%) recommended Modified Dunn procedure. Around 23% of the respondents preferred to do modified Dunn's procedure for all unstable slips while the rest had different approaches to treat this. Single Partially threaded cancellous screw is the preferred implant for in-situ fixation, while a single screw and K wire construct is the preferred construct for in Modified Dunn's procedure. Only 17(16%) of the responders do prophylactic pinning of the opposite hip regularly. Almost 90 responders (96%) do counsel parents about FAI in later stages of life. CONCLUSION: Our study documents that about 70% of the practising paediatric orthopaedic surgeons prefer to do capital realignment procedure for severe stable slips. The treatment of unstable slips remains controversial without any consensus though about 70% believe that there is a role of gentle reduction or positional reduction or skeletal traction. About 50% of the respondents treat less than five slips a year and thus would not possible to generate high-quality evidence based on meagre numbers. This clearly shows that there is a need for developing a national SCFE registry to pool in all data which would help us to arrive at meaningful conclusions to arrive at the ideal management guidelines for SCFE.

Real-life Bioequivalence of Tacrolimus in Patients With Living-Related Donor De Novo Renal Transplantation: An Observational Study.

Tacrolimus is a narrow therapeutic index drug. As a result, regulatory agencies worldwide recommend stringent bioequivalence evaluation criteria for approval of generics. Despite this, the professional transplantation societies have raised concerns over the safety and efficacy of generic substitutions. We conducted this pragmatic real-life bioequivalence study to assess the effect of generic substitutions of tacrolimus. This was an observational study including recipients of renal transplantation who were considered for generic medication substitution. Transplanted organs were from living-related donors and were performed at least 1 month before the study. Time of administration of the drug, time of dosing with respect to meals, and time of blood sample collection were controlled; however, the lot number of the generic drugs was not controlled. The participants were allowed to use their usual supplies irrespective of the lot number. Concentration (C0) was quantified by liquid chromatography with tandem mass spectrometry after the generic substitution from ABC brand to XYZ brand. The average C0 ± SD with generic ABC was 11.09 ± 4.26 ng/mL and generic ABC was 9.7 ± 4.12 ng/mL. Though there was no statistically significant difference observed between the concentrations, when the individual patient data was examined, 2 patients were found to have a very high concentration of tacrolimus and at least 7 patients fell below the therapeutic range. These derangements called for retitration with the new generic tacrolimus (40%). The results of our study suggest that generic-to-generic substitutions should be carried out very carefully in a closely observed setting in patients with renal transplants. The strength of our study is that it matched the real clinical practice setting as much as possible unlike a bioequivalence study. Therefore, we recommend repeating C0 at least 3 times over a period of 7 to 10 days with a generic substitution to prevent untoward consequences.

Development and validation of a liquid chromatography/tandem mass spectrometry assay for the simultaneous determination of nateglinide, cilostazol and its active metabolite 3,4-dehydro-cilostazol in Wistar rat plasma and its application to pharmacokinetic study.

Nateglinide (NTG), an insulin secretogogue, has been studied in rats for drug-drug interaction with cilostazol (CLZ), an antiplatelet agent commonly used in diabetics. We developed a liquid chromatography tandem mass spectrometry (LC-MS/MS) based method that is capable of simultaneous monitoring plasma levels of nateglinide, cilostazol, and its active metabolite 3,4-dehydro-cilostazol (DCLZ). All analytes including the internal standard (Repaglinide) were chromatographed on reverse phase C(18) column (50 mm x 4.6mm i.d., 5 microm) using acetonitrile: 2mM ammonium acetate buffer, pH 3.4 (90:10, v/v) as mobile phase at a flow rate 0.4 ml/min in an isocratic mode. The detection of analyte was performed on LC-MS/MS system in the multiple reaction monitoring (MRM) mode. The quantitations for analytes were based on relative concentration. The method was validated over the concentration range of 20-2000 ng/ml and the lower limit of quantitation was 20 ng/ml. The recoveries from spiked control samples were >79% for all analytes and internal standard. Intra- and inter-day accuracy and precision of validated method were with in the acceptable limits of <15% at all concentration. The quantitation method was successfully applied for simultaneous estimation of NTG, CLZ and DCLZ in a pharmacokinetic drug-drug interaction study in Wistar rats.