Injection af glucocorticoid in the knee before total knee replacement surgery

Phase 1

Conditions: Knee joint arthrosis with hyperalgesia and severe movement related pain
MedDRA version: 17.1Level: LLTClassification code 10003416Term: ArthrosisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-002744-40-DK

Lead Sponsor: Section For Surgical Pathophysiology, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>;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 Outcome Measures

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