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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: TI of the knee; Procedure: Intra-articular CSI

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TI of the knee	Procedure: TI of the knee; 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.
Active Comparator: Intra-articular CSI	Procedure: Intra-articular CSI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Nigel K Arden, MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SEO118