A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation

Background: Patient-specific cutting blocks in total knee arthroplasty have been promoted to improve mechanical alignment, reduce alignment outliers and improve patient outcomes. The aim of this study was to compare the efficacy of patient-specific instrumentation (PSI) and conventional instrumentation (CI) in achieving neutral alignment and accurate component positioning in total knee arthroplasty. Methods: We conducted a double-blinded randomized controlled trial in which patients were randomly assigned to treatment with either PSI or CI. Results: Fifty-four patients were included in the study. No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91. Tibial slope was found to be more accurately reproduced to the preoperative target of 3° with PSI than with CI (3.8°± 3.1° v. 7.7°± 3.6°, respectively, p < 0.001). There were no differences found in patient-reported outcome measures, surgical time or length of hospital stay. Conclusion: Given the added cost of the PSI technique, its use is difficult to justify given the small improvement in only a single alignment parameter. Clinical trial registration: Clinicaltrials.gov, no. NCT03416946

Contexte: L'utilisation de guides de coupe sur mesure dans l'arthroplastie totale du genou a été recommandée pour améliorer l'alignement mécanique, réduire les alignements extrêmes et améliorer les résultats des patients. Cette étude cherchait à comparer la capacité des instruments sur mesure et des instruments classiques à engendrer un alignement neutre et un bon positionnement des composants dans le cadre d'une arthroplastie totale du genou. Méthodes: Nous avons mené un essai clinique randomisé à double insu. Les patients étaient répartis aléatoirement entre le groupe de traitement avec instruments sur mesure et le groupe de traitement avec instruments classiques. Résultats: Cinquante-quatre patients ont participé à l'étude. Aucune différence notable de l'alignement coronal entre les groupes n'a été relevée, pour une puissance observée de 0,91. La pente tibiale correspondait plus exactement à la cible préopératoire de 3° avec les instruments sur mesure qu'avec les instruments classiques (3,8° ± 3,1° contre 7,7° ± 3,6°, respectivement; p < 0,001). Il n'y avait aucune différence dans les mesures déclarées par les patients, la durée de l'intervention et la durée d'hospitalisation. Conclusion: Étant donné l'amélioration minime d'un seul paramètre d'alignement et le coût supérieur de la technique sur mesure, son utilisation est difficile à justifier. Enregistrement de l'essai: Clinicaltrials.gov, no NCT03416946.

Injection technique practices in a population of Canadians with diabetes: results from a recent patient/diabetes educator survey.

OBJECTIVE: A Canadian survey was undertaken to elucidate injection techniques in the population of the country with diabetes and to make appropriate revisions to the 2011 Canadian Forum for Injection Technique recommendations. METHODS: The study involved 503 participants (25% with type 1 diabetes; 75% with type 2 diabetes) from 55 diabetes education centres across Canada. They completed a survey regarding injection technique (i.e. needle length, angle of insertion, incidence of lipohypertrophy, injection routine). Healthcare professionals at the centres also completed a survey regarding their patients' injection techniques. To be eligible for the study, participants had injected either insulin or a glucagon-like peptide-1 receptor agonist for at least 6 months prior to enrolment. RESULTS: Varying lengths of needles were used for injections; however, 45.3% of participants had changed needle lengths since they had begun injecting. The vast majority of participants (80.4%) injected medication into the abdomen; 36.6% had no explicit injection routine, whereas 31.4% injected into the same site at the same time each day. Overall, 24.6% of patients observed lipohypertrophy at injection sites, while only 13.3% of diabetes educators observed the same complication. CONCLUSIONS: The survey allowed for a greater understanding of the strengths and weaknesses of Canadian patients and clinicians in the treatment of diabetes, particularly with respect to injection practices and procedures.

Pen needle preference in a population of Canadians with diabetes: results from a recent patient survey.

OBJECTIVE: To evaluate the safety and efficacy of insulin injections in patients using 8 mm 31 gauge vs. 5 mm 31 gauge pen needles, as determined by A1C results and to measure individual patient satisfaction and compare overall satisfaction regarding the use of the 2 needles. METHODS: The study was completed as a substudy of a single-site, open-label, randomized, 6-month comparative study consisting of 66 obese patients. Prior to the study, all individuals had treated their diabetes with either long-acting insulin glargine or insulin detemir. At the onset of the study, patients were randomized 1:1 to either insulin glargine or neutral protamine Hagedorn insulin. All patients used an 8 mm pen needle for the first 3 months and a 5 mm pen needle for the remaining 3 months. At the conclusion of the trial, patients completed a questionnaire regarding pen needle satisfaction. RESULTS: The 5 mm needle was preferred by 41.8% of study subjects, while the 8 mm needle was preferred by 27.9% of subjects. For other attributes (i.e. overall injection comfort, pain when inserting the needle into the skin and length of needle), the 5 mm needle scored higher than the 8 mm needle and higher also than the percentage of individuals who indicated no preference. CONCLUSIONS: In patients with insulin-treated type 2 diabetes with a mean single-injection volume dose of basal insulin of 50.2 units, the 5 mm needle was generally preferred over the 8 mm needle. The shorter needle was more comfortable and easier to use while being equally effective in delivering insulin.

Replacing Insulin Glargine with Neutral Protamine Hagedorn (NPH) Insulin in a Subpopulation of Study Subjects in the Action to Control Cardiovascular Risk in Diabetes (ACCORD): Effects on Blood Glucose Levels, Hypoglycemia and Patient Satisfaction.

OBJECTIVE: To ensure patient safety when replacing insulin glargine (IG) with neutral protamine Hagedorn (NPH) insulin and to determine differences in blood glucose control, frequency of hypoglycemia, insulin dosing, health resource utilization and quality of life between users of IG and NPH insulin. METHODS: A single-site, open-label, randomized, 6-month comparative study of 66 patients from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Randomization was 1:1 to receive IG or NPH insulin. Data regarding blood glucose control, insulin dosage adjustment and recording of hypoglycemia episodes were obtained through telephone calls; office visits were conducted to measure weight, glycated hemoglobin, fasting plasma glucose and blood glucose profile. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used to measure patients' satisfaction with their diabetes treatment. RESULTS: Rates of symptomatic hypoglycemia did not differ significantly between groups: 37.5±2.2 for the IG group and 31.1±2.1 for the NPH group. However, patients treated with NPH insulin had higher frequencies of severe hypoglycemia (6.1±0.9) compared with 2.7±0.6 for the IG group. A significant difference in changes in glycated hemoglobin (A1C) was observed between the groups: the mean ± standard error A1C decreases from baseline were -0.34%±0.11 for the IG group, vs -0.01%±0.10 for the NPH insulin group. The data obtained from the DTSQ showed greater treatment satisfaction in the IG group compared with the NPH insulin group. CONCLUSIONS: Switching from IG to NPH insulin resulted in more than double the rate of severe hypoglycemias and led to decreased metabolic control. Greater treatment satisfaction was observed with IG, compared with NPH insulin, as measured by change from baseline in the DTSQ scores.