Injection af glucocorticoid in the knee before total knee replacement surgery

Preoperative intraarticular injection of methylprednisolone, in patients scheduled for total knee-arthroplasty

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002744-40-DK

Enrollment

Unknown

Registered

2014-07-02

Start date

2014-09-23

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee joint arthrosis with hyperalgesia and severe movement related pain MedDRA version: 17.1 Level: LLT Classification code 10003416 Term: Arthrosis System Organ Class: 100000004859

Interventions

Trade Name: Depo-medrol Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Depo-Medrol Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg/ml milligram(s)/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 50-80 years - osteosrthrosis scheduled for primary - unilateral knee arthroplasty - severe activity related pain Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: -Allergy towards methylprednisolone -does not speak Danish - Infection (local or systemic) -immunocomprommised - current use of steroid -insulin treated diabetes -Anticoagulent treatment -ASA class >3 -General anaesthesia

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of intrarticular injection of Methylprednisolone in reducing acute postoperative pain after total knee arthroplasty, in patients with signs of severe pre-operative inflammation and pain. ;Secondary Objective: To investigate the effect of intraarticular injection of steroid in reducing acute postoperative pain after total knee arthroplasty, in patients with signs of severe pre-operative inflammation and pain. ;Primary end point(s): Pain during 5 meter walk test at 24 hours;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: To investigate the effect of intrarticular injection of Methylprednisolone in reducing acute postoperative pain after total knee arthroplasty, in patients with signs of severe pre-operative inflammation and pain. ;Secondary Objective: To investigate the effect of intraarticular injection of steroid in reducing acute postoperative pain after total knee arthroplasty, in patients with signs of severe pre-operative inflammation and pain. ;Primary end point(s): Pain during 5 meter walk test at 24 hours;Timepoint(s) of evaluation of this end point: 24 hours

—

Secondary

Measure	Time frame
Secondary end point(s): (A)-Pain at 48 hours (B)-total pain during first 2 weeks (C)-preoperative change in intraarticular IL-6 (D)-preoperative change in pressure threshold;Timepoint(s) of evaluation of this end point: (A): 48 hours (B): 2 weeks (C+D): 1 day preoperatively	—

Countries

Denmark

Contacts

Public ContactIben Engelund Luna

Section For Surgical PAthophysiology, Rigshospitalet

ibenengelundluna@gmail.com004560163901

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026