Overview

This trial is active, not recruiting.

Condition infection of total knee joint prosthesis
Sponsor Rigshospitalet, Denmark
Collaborator The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty
Start date October 2013
End date October 2015
Trial size 6000 participants
Trial identifier NCT02019511, RH-0703

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
prosthesis related infections within 1 year after TKA
time frame: 1 year

Secondary Outcomes

Measure
Frequency and cause of hospital stay >4 days
time frame: primary admission
Frequency and causes of 90 days readmissions
time frame: 90 days after surgery
Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
time frame: 1 year
mortality
time frame: 90 days and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
Principal investigator Christoffer C Jørgensen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.