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

NCT02019511 | Withdrawn DMC

• 1 other identifier: RH-0703
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

Infection of Total Knee Joint Prosthesis

Keywords

Orthopedic surgery; Infections; Steroid; Fast-track; Total knee arthroplasty; Safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Prosthesis related infections 24 months after TKA

  2 years

Study Arms (3)

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.

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients scheduled for primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
• Danish Social security number

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty: collaborator

Study Sites (7)

Aarhus University Hospital

Aarhus, Judland, 8000, Denmark

Location

Farsoe Hospital

Farsø, Judland, 9640, Denmark

Location

Sydvestjydsk Sygehus

Grindsted, Judland, 7200, Denmark

Location

Holstebro Hospital

Holstebro, Judland, 7500, Denmark

Location

Vejle Hospital

Vejle, Judland, 7100, Denmark

Location

Viborg Hospital

Viborg, Judland, 8800, Denmark

Location

Gentofte University Hospital

Gentofte Municipality, Denmark

Location

MeSH Terms

Conditions

Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Henrik Kehlet, MD Prof PhD

  Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

DK (7)