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Completed

NCT Number: NCT01303666

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-articular CSI

Procedure

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.

TI of the knee

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
Feb 25, 2011
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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