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

INTERVENTION: 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)/millilitre Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Concentrate for solution for injection Route of administration of the placebo: Intraarticular use CONDITION: 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 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: 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. ; Primary end point(s): Pain during 5 meter walk test at 24 hours 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. Timepoint(s) of evaluation of this end point: 24 hours SECONDARY OUTCOME: 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 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