- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02019511
Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty
Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
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.
Study Overview
Status
Conditions
Detailed Description
In order to reduce pain intensity as much as possible after surgical procedures, modern multimodal analgesic strategies using different analgetics targeting different mechanism of the pain reception system are used. At the same time this may reduce the use of opioids, which commonly cause sideeffects such as nausea, vomiting, obstipation,urinary retention, itching, respiratory suppression and sedation.
In spite of the use of a wide perioperative multimodal analgesia, pain after total knee arthroplasty (TKA), is stil a considerable clinical problem and need for optimisation of the immediate postoperative pain treatment. There is evidence that "high"dose glucocorticoids administered preoperatively reduces the level of pain and the use of opioids after surgery. A recent review did not give cause for concern regarding use of glucocorticoids in TKA,but found that data on longterm safety aspects are lacking, why no recommendations could be made.
As the limited evidence presently points to af benefit of glucocorticoids without serious side effects, the treatment has been introduced as standard treatment in TKA at several of the departments participating in the Lundbeck Foundation Centre for fast-track Hip and Knee Replacement collaboration.
This study is made to monitor the safety of 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Gentofte, Denmark
- Gentofte University Hospital
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Judland
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Aarhus, Judland, Denmark, 8000
- Aarhus University Hospital
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Farsoe, Judland, Denmark, 9640
- Farsoe Hospital
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Grindsted, Judland, Denmark, 7200
- Sydvestjydsk Sygehus
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Holstebro, Judland, Denmark, 7500
- Holstebro Hospital
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Vejle, Judland, Denmark, 7100
- Vejle Hospital
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Viborg, Judland, Denmark, 8800
- Viborg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients scheduled for primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
- Danish Social security number
Exclusion Criteria:
One of the following contraindications for Methylprednisolone:
- Allergy against Methylprednisolone.
- Currently in systemic treatment with glucocorticoid
- Current gastric ulcer
- Insulin dependent diabetes mellitus
Further contraindications are at the discretion of the individual department/surgeon. The cohort without preoperative Methylprednisolone treatment will be followed as a separate cohort to identify potential selection bias.
- Citizens without Danish social security number are not eligible for this study as follow-up is not possible.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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High dose Steroid
Patients scheduled for primary unilateral elective TKA Age >17 years none of the following contraindications for Methylprednisolone:
Citizens without Danish social security number are not eligible for this study as follow-up is not possible. |
Historical cohort
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:
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Procedures without Steroid
Patients scheduled for primary unilateral elective TKA and age >17 years but who did not receive high dose Methylprednisolone regardless of reason.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prosthesis related infections within 1 year after TKA
Time Frame: 1 year
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Causes if infection are subdivided into the following:
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and cause of hospital stay >4 days
Time Frame: primary admission
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Patients admitted for >4 days will have their discharge files reviewed with regards to causes of this prolonged" stay.
This in accordance with the method used in the Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement registry trials (Clinicaltrials.gov
identifier:NCT01515670)
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primary admission
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Frequency and causes of 90 days readmissions
Time Frame: 90 days after surgery
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These will be found through review of medical files and defined as readmission possibly related to surgery and with overnight stay in hospital.
These will be classified according to the method used in the ongoing trials in the Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement registry (Clin.trials
ID:NCT01515670)
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90 days after surgery
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Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
Time Frame: 1 year
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These will be found through review of medical files and classified appropriately into broad categories depending on data.
Detailed information on each case will be recorded
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1 year
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mortality
Time Frame: 90 days and 1 year
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Incidence of 90 days and 1 year mortality will be reported
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90 days and 1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthesis related infections 24 months after TKA
Time Frame: 2 years
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A separate outcome regarding incidence of prosthesis related infections, as defined in the primary outcome, is planned.
This will not be part of the initial study, but is planned to be an independent follow-up study
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christoffer C Jørgensen, MD, Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet
- Principal Investigator: Troels H Lunn, MD, PhD, Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet
- Study Chair: Henrik Kehlet, MD Prof PhD, Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RH-0703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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