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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303666
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : April 24, 2017
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Intra-articular CSI Procedure: TI of the knee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
Study Start Date : November 2000
Actual Primary Completion Date : July 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.

Primary Outcome Measures :
  1. WOMAC pain (WP)score [ Time Frame: Weeks 0 ]
  2. Visual Analogue Scale [ Time Frame: Weeks 0 ]
  3. WOMAC pain (WP)score [ Time Frame: Weeks 2 ]
  4. WOMAC pain (WP)score [ Time Frame: Weeks 4 ]
  5. WOMAC pain (WP)score [ Time Frame: Weeks 12 ]
  6. WOMAC pain (WP)score [ Time Frame: Weeks 26 ]
  7. Visual Analogue Scale [ Time Frame: Weeks 2 ]
  8. Visual Analogue Scale [ Time Frame: Weeks 4 ]
  9. Visual Analogue Scale [ Time Frame: Weeks 12 ]
  10. Visual Analogue Scale [ Time Frame: Weeks 26 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303666

Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
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Principal Investigator: Nigel K Arden MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
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Responsible Party: Dr Jo Ledingham, Portsmouth Hospitals NHS Trust Identifier: NCT01303666    
Other Study ID Numbers: SEO118
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases