Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty

NCT ID: NCT02019511

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Infection of Total Knee Joint Prosthesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High dose Steroid

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.

No interventions assigned to this group

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:

• 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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christoffer Joergensen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoffer C Jørgensen, MD

Role: PRINCIPAL_INVESTIGATOR

Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet

Troels H Lunn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet

Henrik Kehlet, MD Prof PhD

Role: STUDY_CHAIR

Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet

Locations

Aarhus University Hospital

Aarhus, Judland, Denmark

Farsoe Hospital

Farsø, Judland, Denmark

Sydvestjydsk Sygehus

Grindsted, Judland, Denmark

Holstebro Hospital

Holstebro, Judland, Denmark

Vejle Hospital

Vejle, Judland, Denmark

Viborg Hospital

Viborg, Judland, Denmark

Gentofte University Hospital

Gentofte Municipality, , Denmark

Countries

Denmark

Related Links

http://fthk.dk

webpage of the Lundbeck Foundation Centre for fast-track Hip and Knee Replacement

Other Identifiers

RH-0703

Identifier Type: -

Identifier Source: org_study_id