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

NCT02019511 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-08-07

No results posted yet for this study

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Christoffer C Jørgensen, MD · Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet

  • Troels H Lunn, MD, PhD · Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet

  • Henrik Kehlet, MD Prof PhD · Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-10-31
Completion
2016-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019511 on ClinicalTrials.gov