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

This study has been completed.
Sponsor:
Information provided by:
Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01303666
First received: January 27, 2011
Last updated: February 24, 2011
Last verified: November 2000
History of Changes

January 27, 2011
February 24, 2011
November 2000
July 2003   (final data collection date for primary outcome measure)
  • WOMAC pain (WP)score [ Time Frame: Weeks 0 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Weeks 0 ] [ Designated as safety issue: No ]
  • WOMAC pain (WP)score [ Time Frame: Weeks 2 ] [ Designated as safety issue: No ]
  • WOMAC pain (WP)score [ Time Frame: Weeks 4 ] [ Designated as safety issue: No ]
  • WOMAC pain (WP)score [ Time Frame: Weeks 12 ] [ Designated as safety issue: No ]
  • WOMAC pain (WP)score [ Time Frame: Weeks 26 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Weeks 2 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Weeks 4 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Weeks 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Weeks 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01303666 on ClinicalTrials.gov Archive Site
  • WOMAC physical function score (WF) [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
  • Overall assessment of the impact of the procedure by the patient (five point scale) (PA) [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
  • Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA) [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
  • Time to walk fifty metre [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
  • Analgesic intake [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
  • Side effects of the procedure [ Time Frame: Weeks 0,2,4,12,26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Knee Osteoarthritis
  • 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.
  • 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: TI of the knee
    Intervention: Procedure: TI of the knee
  • Active Comparator: Intra-articular CSI
    Intervention: Procedure: Intra-articular CSI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2004
July 2003   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01303666
SEO118
No
Dr Jo Ledingham, Portsmouth Hospitals NHS Trust
Portsmouth Hospitals NHS Trust
Not Provided
Principal Investigator: Nigel K Arden MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
Portsmouth Hospitals NHS Trust
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP