Knee Osteoarthritis
Conditions
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.
Interventions
PROCEDUREIntra-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.
PROCEDURETI 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.
Sponsors
Portsmouth Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC pain (WP)score | Weeks 0 |
| Visual Analogue Scale | Weeks 0 |
Secondary
| Measure | Time frame |
|---|---|
| Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA) | Weeks 0,2,4,12,26 |
| Time to walk fifty metre | Weeks 0,2,4,12,26 |
| WOMAC physical function score (WF) | Weeks 0,2,4,12,26 |
| Side effects of the procedure | Weeks 0,2,4,12,26 |
| Analgesic intake | Weeks 0,2,4,12,26 |
| Overall assessment of the impact of the procedure by the patient (five point scale) (PA) | Weeks 0,2,4,12,26 |
Outcome results
None listed