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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303666
• Other study ID #: SEO118
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: April 21, 2017
• Start date: November 2000
• Est. completion date: December 2004

Study information

• Verified date: April 2017
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2004
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC pain (WP)score		Weeks 0
Primary	Visual Analogue Scale		Weeks 0
Primary	WOMAC pain (WP)score		Weeks 2
Primary	WOMAC pain (WP)score		Weeks 4
Primary	WOMAC pain (WP)score		Weeks 12
Primary	WOMAC pain (WP)score		Weeks 26
Primary	Visual Analogue Scale		Weeks 2
Primary	Visual Analogue Scale		Weeks 4
Primary	Visual Analogue Scale		Weeks 12
Primary	Visual Analogue Scale		Weeks 26
Secondary	WOMAC physical function score (WF)		Weeks 0,2,4,12,26
Secondary	Overall assessment of the impact of the procedure by the patient (five point scale) (PA)		Weeks 0,2,4,12,26
Secondary	Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)		Weeks 0,2,4,12,26
Secondary	Time to walk fifty metre		Weeks 0,2,4,12,26
Secondary	Analgesic intake		Weeks 0,2,4,12,26
Secondary	Side effects of the procedure		Weeks 0,2,4,12,26