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
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Procedure: Intra-articular CSI
Procedure: TI of the knee

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Portsmouth Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: November 2000
Study Completion Date: December 2004
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TI of the knee 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: Intra-articular CSI 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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303666

Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Investigators
Principal Investigator: Nigel K Arden MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
  More Information

No publications provided

Responsible Party: Dr Jo Ledingham, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01303666     History of Changes
Other Study ID Numbers: SEO118
Study First Received: January 27, 2011
Last Updated: February 24, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014