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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Intra-articular CSI
* Procedure: TI of the knee


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TI of the knee<br> | Procedure: TI of the knee<br>* This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine. After an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles.<br>|
| Active Comparator: Intra-articular CSI<br> | Procedure: Intra-articular CSI<br>* After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain (WP)score |  | Weeks 0 | 
| Visual Analogue Scale |  | Weeks 0 | 
| WOMAC pain (WP)score |  | Weeks 2 | 
| WOMAC pain (WP)score |  | Weeks 4 | 
| WOMAC pain (WP)score |  | Weeks 12 | 
| WOMAC pain (WP)score |  | Weeks 26 | 
| Visual Analogue Scale |  | Weeks 2 | 
| Visual Analogue Scale |  | Weeks 4 | 
| Visual Analogue Scale |  | Weeks 12 | 
| Visual Analogue Scale |  | Weeks 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC physical function score (WF) |  | 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 | 
| Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA) |  | Weeks 0,2,4,12,26 | 
| Time to walk fifty metre |  | Weeks 0,2,4,12,26 | 
| Analgesic intake |  | Weeks 0,2,4,12,26 | 
| Side effects of the procedure |  | Weeks 0,2,4,12,26 |