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1.
BMJ Open ; 11(1): e041096, 2021 01 28.
Article in English | MEDLINE | ID: mdl-33509845

ABSTRACT

INTRODUCTION: The current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA). METHODS AND ANALYSIS: A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register. ETHICS AND DISSEMINATION: The trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04135170.


Subject(s)
Anti-Bacterial Agents , Arthroplasty, Replacement, Knee , Prosthesis-Related Infections , Anti-Bacterial Agents/therapeutic use , Arthroplasty, Replacement, Knee/adverse effects , Bone Cements , Europe , Humans , Norway , Prosthesis-Related Infections/drug therapy , Prosthesis-Related Infections/prevention & control , Quality of Life
2.
Tidsskr Nor Laegeforen ; 126(12): 1602-4, 2006 Jun 08.
Article in Norwegian | MEDLINE | ID: mdl-16770370

ABSTRACT

BACKGROUND: Our aim was to investigate the extent, management and use of resources in patients admitted for acute abdominal pain. MATERIAL AND METHODS: A prospective analysis of patients admitted as emergencies with acute abdominal pain of less than seven days duration was performed during two 3-month periods in 2000 and 2001. RESULTS: 483 patients, 262 women and 221 men with median age 50 years were registered. Median duration of pre-hospital symptoms was 16.5 hours. At discharge, non-specific abdominal pain was the most frequent diagnosis (26%), followed by acute appendicitis (12%), acute biliary disease (12%), ileus and ureterolithiasis (both 6%) and diverticulitis (5%). 31% of the patients presented during normal working hours, whereas 69% were admitted during nighttime and/or weekends. Only 23% of the patients needed an acute operation. The overall mortality was 0.4%. The median stay in hospital was two days (0-165 days). 43% of the patients were discharged in less than one day, and 48% had no need for any medical treatment. The patient group occupied 17% of the beds and resources in our surgical department. INTERPRETATION: Patients with acute abdominal pain is a heterogenous group that occupies a great deal of a surgical department's resources. It might be cost-effective to examine these patients in an observational unit supervised by well-trained surgeons.


Subject(s)
Abdomen, Acute/diagnosis , Patient Admission , Abdomen, Acute/surgery , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Cost-Benefit Analysis , Female , Humans , Infant , Length of Stay/economics , Length of Stay/statistics & numerical data , Male , Middle Aged , Patient Admission/economics , Patient Admission/statistics & numerical data , Prospective Studies , Surgery Department, Hospital/economics , Surgery Department, Hospital/statistics & numerical data
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