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

April 21, 2017 updated by: Portsmouth Hospitals NHS Trust
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Weeks 0
Weeks 0
Visual Analogue Scale
Time Frame: Weeks 0
Weeks 0
WOMAC pain (WP)score
Time Frame: Weeks 2
Weeks 2
WOMAC pain (WP)score
Time Frame: Weeks 4
Weeks 4
WOMAC pain (WP)score
Time Frame: Weeks 12
Weeks 12
WOMAC pain (WP)score
Time Frame: Weeks 26
Weeks 26
Visual Analogue Scale
Time Frame: Weeks 2
Weeks 2
Visual Analogue Scale
Time Frame: Weeks 4
Weeks 4
Visual Analogue Scale
Time Frame: Weeks 12
Weeks 12
Visual Analogue Scale
Time Frame: Weeks 26
Weeks 26

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portsmouth Hospitals NHS Trust

Investigators

  • Principal Investigator: Nigel K Arden, MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • SEO118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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