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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intra-articular CSI
TI of the knee
Sponsored by
Portsmouth Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TI of the knee

    Intra-articular CSI

    Arm Description

    Outcomes

    Primary Outcome Measures

    WOMAC pain (WP)score
    Visual Analogue Scale
    WOMAC pain (WP)score
    WOMAC pain (WP)score
    WOMAC pain (WP)score
    WOMAC pain (WP)score
    Visual Analogue Scale
    Visual Analogue Scale
    Visual Analogue Scale
    Visual Analogue Scale

    Secondary Outcome Measures

    WOMAC physical function score (WF)
    Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
    Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
    Time to walk fifty metre
    Analgesic intake
    Side effects of the procedure

    Full Information

    First Posted
    January 27, 2011
    Last Updated
    April 21, 2017
    Sponsor
    Portsmouth Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01303666
    Brief Title
    Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
    Official Title
    Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2000 (undefined)
    Primary Completion Date
    July 2003 (Actual)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Portsmouth Hospitals NHS Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TI of the knee
    Arm Type
    Active Comparator
    Arm Title
    Intra-articular CSI
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Intra-articular CSI
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    TI of the knee
    Intervention Description
    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 Outcome Measure Information:
    Title
    WOMAC pain (WP)score
    Time Frame
    Weeks 0
    Title
    Visual Analogue Scale
    Time Frame
    Weeks 0
    Title
    WOMAC pain (WP)score
    Time Frame
    Weeks 2
    Title
    WOMAC pain (WP)score
    Time Frame
    Weeks 4
    Title
    WOMAC pain (WP)score
    Time Frame
    Weeks 12
    Title
    WOMAC pain (WP)score
    Time Frame
    Weeks 26
    Title
    Visual Analogue Scale
    Time Frame
    Weeks 2
    Title
    Visual Analogue Scale
    Time Frame
    Weeks 4
    Title
    Visual Analogue Scale
    Time Frame
    Weeks 12
    Title
    Visual Analogue Scale
    Time Frame
    Weeks 26
    Secondary Outcome Measure Information:
    Title
    WOMAC physical function score (WF)
    Time Frame
    Weeks 0,2,4,12,26
    Title
    Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
    Time Frame
    Weeks 0,2,4,12,26
    Title
    Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
    Time Frame
    Weeks 0,2,4,12,26
    Title
    Time to walk fifty metre
    Time Frame
    Weeks 0,2,4,12,26
    Title
    Analgesic intake
    Time Frame
    Weeks 0,2,4,12,26
    Title
    Side effects of the procedure
    Time Frame
    Weeks 0,2,4,12,26

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nigel K Arden
    Organizational Affiliation
    MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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