NCT01303666

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

January 27, 2011

Last Update Submit

April 21, 2017

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (10)

  • WOMAC pain (WP)score

    Weeks 0

  • Visual Analogue Scale

    Weeks 0

  • WOMAC pain (WP)score

    Weeks 2

  • WOMAC pain (WP)score

    Weeks 4

  • WOMAC pain (WP)score

    Weeks 12

  • WOMAC pain (WP)score

    Weeks 26

  • Visual Analogue Scale

    Weeks 2

  • Visual Analogue Scale

    Weeks 4

  • Visual Analogue Scale

    Weeks 12

  • Visual Analogue Scale

    Weeks 26

Secondary Outcomes (6)

  • WOMAC physical function score (WF)

    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

  • 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

  • Analgesic intake

    Weeks 0,2,4,12,26

  • +1 more secondary outcomes

Study Arms (2)

TI of the knee

ACTIVE COMPARATOR
Procedure: TI of the knee

Intra-articular CSI

ACTIVE COMPARATOR
Procedure: Intra-articular CSI

Interventions

Intra-articular CSIPROCEDURE

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.

Intra-articular CSI
TI of the kneePROCEDURE

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.

TI of the knee

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Craniospinal Irradiation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Nigel K Arden

    MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 25, 2011

Study Start

November 1, 2000

Primary Completion

July 1, 2003

Study Completion

December 1, 2004

Last Updated

April 24, 2017

Record last verified: 2017-04