Clinical trial NCT02019511: Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty
Official title: Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infection of Total Knee Joint Prosthesis
Keywords: Orthopedic surgery
Infections
Steroid
Fast-track
Total knee arthroplasty
Safety
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty
First posted: 2013-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: prosthesis related infections within 1 year after TKA
timeFrame: 1 year
Secondary outcomes:
measure: Frequency and cause of hospital stay >4 days
timeFrame: primary admission
measure: Frequency and causes of 90 days readmissions
timeFrame: 90 days after surgery
measure: Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
timeFrame: 1 year
measure: mortality
timeFrame: 90 days and 1 year
Other outcomes:
measure: Prosthesis related infections 24 months after TKA
timeFrame: 2 years
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Judland
city: Farsoe
country: Denmark
facility: Farsoe Hospital
state: Judland
city: Grindsted
country: Denmark
facility: Sydvestjydsk Sygehus
state: Judland
city: Holstebro
country: Denmark
facility: Holstebro Hospital
state: Judland
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Judland
city: Viborg
country: Denmark
facility: Viborg Hospital
state: Judland
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet
name: Christoffer C Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet
name: Troels H Lunn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet
name: Henrik Kehlet, MD Prof PhD
role: STUDY_CHAIR
References: