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BACKGROUND AND PURPOSE: Limited data exists on the implementation process and safety of discharge on the day of surgery after primary hip and knee arthroplasty in a multicenter setting. We report our study protocol on the investigation of the feasibility, safety, and socioeconomic aspects following discharge on day of surgery after hip and knee arthroplasty across 8 fast-track centers. PATIENTS AND METHODS: This is a study protocol for a prospective cohort study on discharge on day of surgery from the Center for Fast-track Hip and Knee Replacement. The collaboration includes 8 centers covering 40% of the primary hip and knee arthroplasty procedures undertaken in Denmark. All patients scheduled for surgery are screened for eligibility using well-defined inclusion and exclusion criteria. Eligible patients fulfilling discharge criteria will be discharged on day of surgery. We expect to screen 9,000 patients annually. Duration and outcome: Patients will be enrolled over a 3-year period from September 2022 and reporting of results will run continuously until December 2025. We shall report the proportion of eligible patients and patients discharged on day of surgery as well as limiting factors. Readmissions and complications within 30 days are recorded with real-time follow-up by research staff. Furthermore, patient-reported information on willingness to repeat discharge on day of surgery, contacts with the healthcare system, complications, and workability is registered 30 days postoperatively. EQ-5D, Oxford Knee Score, and Oxford Hip Score are completed preoperatively and after 3 months and 1 year. Finally, outcome data will be used in the development of a prediction model for successful discharge on the day of surgery.
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Artroplastia de Quadril , Artroplastia do Joelho , Humanos , Alta do Paciente , Estudos Prospectivos , Tempo de Internação , Artroplastia do Joelho/métodos , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/métodos , Estudos Multicêntricos como AssuntoRESUMO
INTRODUCTION: A feared complication after total hip arthroplasty (THA) is prosthetic joint infection (PJI), associated with high morbidity and mortality. Prophylactic antibiotics can reduce the risk of PJI. However, there is no consensus on the dosages and current recommendations are based on a low evidence level. The objective is to compare the effect of a single versus multiple doses of prophylactic antibiotics administered within 24 hours on PJI. METHODS AND ANALYSIS: The study is designed as a cross-over, cluster randomised, non-inferiority trial. All clinical centres use both antibiotic practices (1 year of each intervention). All Danish orthopaedic surgery departments will be involved: Based on quality databases, 2-year cohorts of approximately 20 000 primary THAs conducted at 39 public and private hospitals, will be included. INCLUSION CRITERIA: age ≥18 years, all indications for THA except patients operated due to acute or sequelae from proximal femoral or pelvic fractures or bone tumour or metastasis. The primary outcome is PJI within 90 days after primary THA. Secondary outcomes include (1) serious adverse events, (2) potential PJI, (3) length of hospitalisation stay, (4) cardiovascular events, (5) hospital-treated infections, (6) community-based antibiotic use, (7) opioid use and (8) use of acetaminophen and non-steroidal anti-inflammatory drugs. All outcome measures will be extracted from national databases. Analyses will be based on the intention-to-treat population. Non-inferiority will be shown if the upper limit of the two-sided 95% CI for the OR is less than 1.32 for the single dose as compared with multiple doses. The results will establish best practice on antibiotic prophylaxis dosages in the future. ETHICS AND DISSEMINATION: This study has been approved by Committees on Health Research Ethics for The Capital Region of Denmark (21069108) and The Danish Medicines Agency (2021091723). All results will be presented in peer-reviewed medical journals and international conferences. TRIAL REGISTRATION NUMBER: NCT05530551.
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Artroplastia de Quadril , Infecção Hospitalar , Osteoartrite , Humanos , Adolescente , Artroplastia de Quadril/efeitos adversos , Hospitais Privados , Antibacterianos/uso terapêutico , Dinamarca , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: A single injection of bupivacaine after wound closure reduces the need for analgesics and increases flexion after total knee replacement (TKR). We have therefore studied the effect of continuous injection of morphine and ropivacaine after TKR on range of movement and length of hospital stay. PATIENTS AND METHODS: In an open intervention study, we assigned 154 consecutive patients who had primary unilateral TKR for osteoarthrosis. The intervention was continuous intraarticular injection of morphine 20 mg/mL, 0.5 mL plus ropivacaine 2 mg/mL, 100 mL; bolus 20 mL and 2 mL/hour from 24 to 72 hours postoperatively. Group 1 (10 women and 8 men) received standard postoperative analgesics and group 2 (11 women and 7 men) also received continuous intraarticular morphine and ropivacaine as described above. Group 3 (14 women and 4 men) received double this dose (4 mL/hour) from 24 to 72 hours postoperatively. To assess the safety of the intraarticular treatment, an additional group of 100 consecutive patients was followed (group 4). RESULTS: At discharge, flexion was 70 degrees (60-100) in group 1, 100 degrees (70-115) in group 2 and 110 degrees (90-130) in group 3. Hospital stay was reduced from 9 (7-11) days in group 1, to 7 (5-10) days in groups 2 and 3. Number of days elapsed until the patient was walking with crutches was reduced from 5 (3-8) to 4 (3-6) and 3 (3-9), respectively. In the intervention groups, the need for analgesics was reduced during the hospital stay. Deep infection was registered in 1 patient. INTERPRETATION: Continuous intraarticular morphine and ropivacaine reduce pain and enhance rehabilitation after total knee replacement. Before advocating this as a standard procedure, further large-scale randomized studies will be needed to assess the safety of this regimen.