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
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
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
NCT ID
NCT01303666
First Posted
January 27, 2011
Last Updated
April 21, 2017
Sponsor
Portsmouth Hospitals NHS Trust
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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