Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial.

INTRODUCTION: Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution. METHODS AND ANALYSIS: The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery. ETHICS AND DISSEMINATION: All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04850300).

Short-Course High-Intensity Statin Treatment during Admission for Myocardial Infarction and LDL-Cholesterol Reduction-Impact on Tailored Lipid-Lowering Therapy at Discharge.

We hypothesized that a short-course high-intensity statin treatment during admission for myocardial infarction (MI) could rapidly reduce LDL-C and thus impact the choice of lipid-lowering therapy (LLT) at discharge. Our cohort comprised 133 MI patients (62.71 ± 11.3 years, 82% male) treated with atorvastatin 80 mg o.d. during admission. Basal LDL-C levels before admission were analyzed. We compared lipid profile variables before and during admission, and LLT at discharge was registered. Achieved theoretical LDL-C levels were estimated using LDL-C during admission and basal LDL-C as references and compared to LDL-C on first blood sample 4-6 weeks after discharge. A significant reduction in cholesterol from basal levels was noted during admission, including total cholesterol, triglycerides, HDL-C, non-HDL-C, and LDL-C (-39.23 ± 34.89 mg/dL, p < 0.001). LDL-C levels were reduced by 30% in days 1-2 and 40-45% in subsequent days (R2 0.766, p < 0.001). Using LDL-C during admission as a reference, most patients (88.7%) would theoretically achieve an LDL-C < 55 mg/dL with discharge LLT. However, if basal LDL-C levels were considered as a reference, only a small proportion of patients (30.1%) would achieve this lipid target, aligned with the proportion of patients with LDL-C < 55 mg/dL 4-6 weeks after discharge (36.8%). We conclude that statin treatment during admission for MI can induce a significant reduction in LDL-C and LLT at discharge is usually prescribed using LDL-C during admission as the reference, which leads to insufficient LDL-C reduction after discharge. Basal LDL-C before admission should be considered as the reference value for tailored LLT prescription.

A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement.

PURPOSE: To investigate the effects of including balance training in a preoperative strengthening intervention on balance and functional outcomes in patients undergoing total knee replacement (TKR) and compare these effects to those induced by preoperative strengthening and no intervention. METHODS: Eighty-two subjects scheduled for TKR were randomly allocated into the strengthening (ST, n = 28) group: a preoperative lower limb strengthening intervention; the strengthening + balance (ST + B, n = 28) group: same intervention augmented with balance training; and the control group (n = 26). The Berg Balance Scale (BBS) and the function in daily living subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS-ADL) were the primary outcomes. The secondary measures included balance and mobility, self-reported status, and knee function. The outcomes were assessed at baseline, 1 week before surgery, and 2, (primary endpoint), 6 and 52 weeks after surgery. RESULTS: Compared with the controls, the participants in the ST and ST + B groups presented significant improvements from baseline to the end of the preoperative intervention in BBS (p = 0.005) and KOOS-ADL (p < 0.001). At 6 weeks post-surgery, the knee extensor strength values were similar in the two treatment groups and significantly higher than that in the controls. Overall, the participant outcomes in all groups stabilized at 1 year after surgery. CONCLUSION: A preoperative strengthening intervention, regardless of whether it is complemented with balance training, enhances strength but not balance or functional outcomes at 6 weeks after surgery. Patients are expected to present similar performance at 1 year postoperatively, but adequately statistically powered trials are needed to confirm the findings. LEVEL OF EVIDENCE: II. TRIAL REGISTRATION: NCT02995668.

[The quality of care in shoulder pain. A medical audit]. / La calidad de la atención al hombro doloroso. Audit clínico.

BACKGROUND: To evaluate the quality of hospital ambulatory care in non-surgical painful shoulder by auditing medical records using quality indicators. MATERIAL AND METHODS: We reviewed 245 medical records of non-surgical patients assisted for pain shoulder in 1999-2000 in two public hospitals. Quality of care indicators for antecedents, physic exploration, diagnosis and treatment were developed based in systematic reviews of clinical trials, guidelines and expert criteria. Medical records review was carried out by two rehabilitative doctors. Fulfilling of quality criteria and differences between hospitals was analyzed. RESULTS: 76.3% of the medical records did not fulfill > or = 4 of 10 quality criteria for antecedents, 61.6% did not fulfill > or = 3 of 10 criteria for physical exploration, and 7.7% did not have any diagnosis registered. 96.9% of the 98 patients with impingement syndrome did not complete the criteria of anti-inflammatory treatment or infiltration in the pre-established time, and up to 15.3% had not been proposed physiotherapy or programmed exercise in the 4 weeks after the diagnosis; 95.8% of the 24 patients with rotators cuff tears were not proposed for early surgical evaluation, and 86.7% of the 15 cases of adhesive capsulitis did not receive instructions to carry out programmed exercise in the proposed times. CONCLUSIONS: The audit revealed significant deficiencies in adherence to quality indicators in non-surgical pain shoulder. Part of these problems can be due to low medical records quality.