Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Intra-articular CSI; Procedure: TI of the knee

• Registration Number: NCT01303666
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2003-07
• Study Completion: 2004-12
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Clinical diagnosis of knee OA
• Knee pain for most days of the prior month
• Radiographic evidence consistent with knee OA
• Aged between 40 and 90 years old

Exclusion Criteria

• Symptomatic hip OA
• Co-existent inflammatory or crystal arthritis
• Prior knee surgery
• Injury to the knee in the preceding 6 months
• Any intra-articular injection in the preceding 3 months
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular CSI	Intra-articular CSI	-
TI of the knee	TI of the knee	-

Primary Outcome Measures

Name	Time	Method
WOMAC pain (WP)score	Weeks 26
Visual Analogue Scale	Weeks 26

Secondary Outcome Measures

Name	Time	Method
Analgesic intake	Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the patient (five point scale) (PA)	Weeks 0,2,4,12,26
Time to walk fifty metre	Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)	Weeks 0,2,4,12,26
WOMAC physical function score (WF)	Weeks 0,2,4,12,26
Side effects of the procedure	Weeks 0,2,4,12,26