Clinical practice guidelines: The good, the bad, and the ugly.

Clinical practices guidelines (CPGs) play a fundamental role in improving healthcare and patients' outcomes by helping clinicians make the best evidence-based decisions for their patients in a time-efficient manner. By following the available methods and criteria to create trustworthy CPGs, panel members can develop high-quality guidelines. However, despite the improvements over the years, CPGs are still subjected to biases and limitations, with conflicts of interest being the ugliest problem GCPs must face. In this review, we discuss the main characteristics of clinical practice guidelines, their pros and cons, and the future challenges they need to overcome.

Complications of standard versus long cephalomedullary nails in the treatment of unstable extracapsular proximal femoral fractures: A randomized controlled trial.

AIMS: To compare in a prospective randomized trial the mechanical complications in patients with unstable extracapsular proximal femur fractures without subtrochanteric extension (AO/OTA 31-A2 and 31-A3) METHODS: We prospectively studied 182 patients with unstable extracapsular proximal femur fractures without fractures lines extending more than 3 cm below the lesser trochanter, randomized to receive either a 'standard' (240 mm) nail or a long nail and followed them up for 1 year. RESULTS: We found no difference in the incidence of mechanical or general complications between the two groups, no cut-outs, no fractures of the tip the implant, 1 cut-through and 2 malrotations in the LN group, 2 non-unions that were reoperated, one on each group. The commonest complication was blade lateral migration, 13 (14%) patients in SN and 6 (9%) in the LN. The operating time was shorter in the SN group 51 minutes compared to 67 minutes in the LN group (p=0.000075). The mortality at 1,3 and 12 months in the SN group was of 2%, 6%, 12% while in the LN group was 12%, 18% and 22%. These differences where significative at 1 (p=0.007) and 3 months (p=0.013), but not at 12 months (p=0.075). CONCLUSIONS: We recommend the use of standard nails (240 mm) for this group of fractures, since it does not produce more mechanical complications, and it is faster, cheaper and easier to interlock distally.

Is elective surgery during the COVID-19 pandemic safe? A multi-center prospective study in a high incidence area.

OBJECTIVE: The aim of this study was to describe the evolution of patients admitted for elective orthopaedic surgery during the immediate post-COVID-19 peak of the pandemic. METHODS: This is a multi-center, observational study conducted in 8 high complexity hospitals of Catalonia, one of the highest COVID-19 incidence areas in Spain. We included patients ≥18 years of age undergoing elective surgery (total knee or hip arthroplasty, knee or hip revision arthroplasty, shoulder or knee arthroscopy, hand or wrist surgery, forefoot surgery, or hardware removal) after the COVID-19 peak (between May 5th and June 30th, 2020). The main exclusion criterion was a positive result for SARS-CoV-2 PCR within the 7 days before the surgery. The primary outcomes were postoperative complications within 60 days (+/-30) or hospital readmission due to a COVID-19 infection. Following the recommendations of the International Consensus Group (ICM), elective surgeries were re-started when the nationwide lockdown was lifted. Before the surgery, patients were contacted by phone to rule out any exposure to confirmed COVID-19 cases, a reverse transcription-polymerase chain reaction (PCR) assay was performed in all patients 48-72 hours before hospital admission, and they were asked to maintain home confinement until the day of the surgery. RESULTS: 675 patients were included: 189 patients in the arthroplasty group (28%) and 486 in the ambulatory surgery group (72%). Mean [SD] age was 57.6 [15.3] years. The mean Charlson Comorbidity Index score was 2.21 (SD = 2.01, Min = 0, Max = 13). A total of 84 patients (12.75%) obtained an American Society of Anesthesiologists (ASA) score ≥ 3, showing no association between the ASA score and the risk of developing COVID-19 symptoms at follow-up (χ 2 (4) = 0.77, P = 0.94). The mean occupation rate of hospital beds for COVID-19 patients was 13% and the mean occupation rate of critical care beds for COVID-19 patients was 27% at the time of re-introducing elective surgeries. These were important rates to consider to decide when to reintroduce elective surgeries after lockdown. Surgical time, time of ischemia and intra-operative bleeding were not related with a higher risk of developing COVID-19 post-operatively (χ 2 (1) = 0.00, P = 0.98); (χ 2 (2) = 2.05, P = 0.36); (χ 2 (2) = 0.37, P = 0.83). Only 2 patients (0.3 %) presented with a suspected COVID-19 infection at follow-up. None of them presented with pneumonia or required confirmation by a reverse transcription PCR assay. Hospital re-admission was not needed for these patients. CONCLUSION: The risk of developing COVID-19 during the immediate post-COVID-19 peak in a region with a high incidence of COVID-19 has not been proved. These data suggest that elective orthopaedic surgeries can be resumed when assertive and strict protocols are followed.

"Can patients learn how to reduce their shoulder dislocation?" A one-year follow-up of the randomized clinical trial between the Boss-Holzach-Matter self-assisted technique and the Spaso method.

OBJECTIVE: The aim of this study was to assess the effectiveness and reproducibility of self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp) method for shoulder dislocation. METHODS: We conducted a follow-up at 1 year from the randomization of 60 patients with shoulder dislocation enrolled in the study "Teaching patients to reduce a shoulder dislocation." Half of these patients had been taught the self-assisted technique, whereas the other half had been treated by a physician's manipulative maneuver for reduction. We surveyed all the enrolled patients to describe recurrence rates and reproducibility for both the techniques without supervision as well as the number of emergency visits. RESULTS: In total, 52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study. The total rate of recurrence was 38.5% (20 patients). For the Sp group, 4 of the 30 patients were lost. There were 9 recurrent patients (30%), and 7 were treated in the emergency department (ED). For the BHM group, 4 of the 30 patients were lost. There were 11 recurrent patients (37%), and 2 were treated in the ED. The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025). CONCLUSION: Teaching the BHM technique to the patients is effective and reproducible without direct supervision. It can decrease the number of visits to the ED and is a valid option to teach the patients at risk of recurrence when not being able to get immediate help. LEVEL OF EVIDENCE: Level I, Therapeutic study.

¿Podemos ayudar? Nuestra experiencia como cirujanos ortopédicos durante la pandemia por COVID / Can we help? Our experience as orthopedic surgeons during the COVID-19 pandemic

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All-Arthroscopic Nanofractured Autologous Matrix-Induced Chondrogenesis (A-NAMIC) Technique for the Treatment of Focal Chondral Lesions of the Knee.

Nanofractured autologous matrix-induced chondrogenesis (NAMIC©) is a 1-step technique that combines nanofracture needling to induce bone marrow stimulation (BMS) and the use of cell-free collagen matrix to optimize cartilage regeneration. In this Technical Note, we describe a modification of the NAMIC procedure using mosaicplasty trephines to prepare the lesion surface and to shape collagen implants in an all-arthroscopic approach (A-NAMIC). This technique is indicated for the treatment of International Cartilage Repair Society grade III to IV knee chondral lesions of ≤4 cm2. After damaged cartilage is debrided, trephines are used to create a flat, circular lesion surfaces. Subsequently, BMS is performed with nanofracture, eliciting reproducible and stop-controlled subchondral bone perforations of 9-mm depth and 1-mm width. The collagen membrane is then cut to size with the trephine, placed over the prepared defect, and secured with fibrin glue, preventing loss of regenerating cells and growth factors to the joint space. Using trephines allows the rapid and precise creation of smooth defect surfaces with known dimensions, ensuring optimal lesion coverage. Additionally, nanofracture reduces trabecular compaction and allows for a deeper access to subchondral bone in comparison with conventional microfracture, improving lesion filling and production of cartilage with higher hyaline content.

Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial.

INTRODUCTION: Inflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI. METHODS AND ANALYSIS: Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy. ETHICS AND DISSEMINATION: We obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients.

INTRODUCTION: Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications. METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients. ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

Teaching Patients How to Reduce a Shoulder Dislocation: A Randomized Clinical Trial Comparing the Boss-Holzach-Matter Self-Assisted Technique and the Spaso Method.

BACKGROUND: There are many different techniques for reducing acute anterior dislocations of the shoulder, and their use depends on surgeon preference. The objective of this study was to compare the pain experienced by a patient performing a self-reduction technique with the pain felt during a reduction performed by a trained physician. METHODS: The study was carried out at the emergency department of a tertiary referral center. Patients between 18 and 60 years of age with an acute anterior shoulder dislocation were randomly allocated into 2 groups. In 1 group the emergency doctor actively guided the reduction process with the Spaso technique (Sp group), and in the other group the patient used the Boss-Holzach-Matter (also known as Davos or Aronen) self-reduction technique (BHM group). The pain experienced by the patient during the reduction was recorded by means of a visual analogue scale (VAS) ranging from 0 to 10. Other recorded data included demographic characteristics, reduction time, and success rate. RESULTS: Of 378 patients assessed for eligibility from May 2015 until February 2017, 197 did not meet the inclusion criteria, 58 met exclusion criteria, 22 declined to participate, and 41 withdrew before randomization. Sixty acute anterior shoulder dislocations were randomized into the Sp group (n = 30) or the BHM group (n = 30). The BHM group experienced significantly less pain during reduction than the Sp group (p = 0.047), with mean pain scores of 3.57 (standard deviation [SD] = 2.1]) and 5.26 (SD = 2.9), respectively. No significant difference between groups was found with respect to reduction time (105 seconds [range, 10 to 660 seconds] in the Sp group and 90 seconds [range, 5 to 600 seconds] in the BHM group; p = 0.6) or success rate (67% and 77%, respectively; p = 0.39). CONCLUSIONS: The self-reduction technique results in less pain than, and is as efficient in achieving reduction of anterior shoulder dislocations as, the Spaso technique. These findings favor the use of the self-assisted method as an effective first-line treatment for shoulder dislocations seen in the emergency department as well as its use by patients with recurrent dislocation. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.