Sponsor study identifier
observational
0
1 country
7
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2016
Actual (reported)It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Although there are some concerns about the possibility of increased risk of prosthesis infections, this has not been proved in previous studies. However the studies are few, have limited number of patients and are not done using a standardized perioperative set-up. This study is made to monitor the safety of a single high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery. We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 18, 2013
Actual (reported)December 24, 2013
Actual (reported)October 2015
Actual (reported)October 2016
Actual (reported)prosthesis related infections within 1 year after TKA
Causes if infection are subdivided into the following: 1. Deep prosthesis related infection 2. Superficial infection (defined as surgery verified infection above level of the fascia) 3. Clinical / paraclinical suspicion of infection only treated with intravenous antibiotics (no surgical procedure) 4. Possible infection, but no clinical/paraclinical suspicion of infection, why the patient is discharged without intravenous antibiotic treatment/surgery. 5. Surgical wound revision (no clinical/paraclinical suspicion of infection) 6. Surgical knee manipulation due to limited range of movement (no clinical/paraclinical suspicion of infection). 7. Surgery due to aseptic non-traumatic loosening of the knee. 8. Surgery due to traumatic loosening of the knee
1 year
Frequency and cause of hospital stay >4 days
primary admission
Frequency and causes of 90 days readmissions
90 days after surgery
Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
1 year
mortality
90 days and 1 year
Prosthesis related infections 24 months after TKA
2 years
Patients scheduled for primary unilateral elective TKA Age \>17 years none of the following contraindications for Methylprednisolone: * Allergy against Methylprednisolone. * Currently in systemic treatment with glucocorticoid * Current gastric ulcer * Insulin dependent diabetes mellitus Citizens without Danish social security number are not eligible for this study as follow-up is not possible.
Patients having primary unilateral elective TKA before initiation of Methylprednisolone as standard treatment age \>17 years, Danish social security number and none of the following at time of surgery: * systemic treatment with glucocorticoid defined as: regular prescriptions on glucocorticoid within 2 months prior to surgery. * gastric ulcer defined as: prescriptions on drugs used in "triple therapy" for Helicobacter Pylori infection or prescriptions on antiacids/proton pump inhibitors beginning 1 month before surgery * Insulin dependent diabetes mellitus defined as: any prescriptions on insulin within 6 months prior to surgery
Patients scheduled for primary unilateral elective TKA and age \>17 years but who did not receive high dose Methylprednisolone regardless of reason.
Consecutive unselcted patients with unilateral elective total fast-track knee arthroplasty in a standardized perioperative set-up and with completed prospective registration of preoperative chartacteristics and co-morbidity
Aarhus University Hospital
Aarhus, Judland, 8000, Denmark
Farsoe Hospital
Farsø, Judland, 9640, Denmark
Sydvestjydsk Sygehus
Grindsted, Judland, 7200, Denmark
Holstebro Hospital
Holstebro, Judland, 7500, Denmark
Vejle Hospital
Vejle, Judland, 7100, Denmark
Viborg Hospital
Viborg, Judland, 8800, Denmark
Gentofte University Hospital
Gentofte Municipality, Denmark
Christoffer C Jørgensen, MD
Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet
Troels H Lunn, MD, PhD
Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet
Henrik Kehlet, MD Prof PhD
Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet
0 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
August 7, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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