Knee OsteoarthritisNCT01303666
Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
A study testing Intra-articular CSI and TI of the knee in people with Knee Osteoarthritis, run by Portsmouth Hospitals NHS Trust.
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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular CSI and TI of the knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intra-articular CSI, TI of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular CSIProcedure or surgery
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 kneeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TI of the knee | Active comparator | Not described Receives: Procedure: TI of the knee |
| Intra-articular CSI | Active comparator | Not described Receives: Procedure: Intra-articular CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC pain (WP)score
Measured: Weeks 0
Visual Analogue Scale
Measured: Weeks 0
WOMAC pain (WP)score
Measured: Weeks 2
WOMAC pain (WP)score
Measured: Weeks 4
WOMAC pain (WP)score
Measured: Weeks 12
WOMAC pain (WP)score
Measured: Weeks 26
Visual Analogue Scale
Measured: Weeks 2
Visual Analogue Scale
Measured: Weeks 4
Visual Analogue Scale
Measured: Weeks 12
Visual Analogue Scale
Measured: Weeks 26
Secondary outcomes (6)
WOMAC physical function score (WF)
Measured: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
Measured: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
Measured: Weeks 0,2,4,12,26
Time to walk fifty metre
Measured: Weeks 0,2,4,12,26
Analgesic intake
Measured: Weeks 0,2,4,12,26
Side effects of the procedure
Measured: Weeks 0,2,4,12,26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startNov 2000
- Primary completionJul 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Investigators
- Nigel K Arden, Principal investigator, MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303666
- Sponsor's protocol ID
- SEO118
- Status last verified
- Apr 2017
- First submitted
- 27 Jan 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01303666
- Acronym / sponsor ID
- SEO118
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- Nov 2000
- Primary completion
- Jul 2003 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TI of the knee | Active comparator | Procedure: TI of the knee |
| Intra-articular CSI | Active comparator | Procedure: Intra-articular CSI |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular CSIAfter 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. | Procedure or surgery | Intra-articular CSI |
| TI of the kneeThis 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. | Procedure or surgery | TI of the knee |
Primary outcome
WOMAC pain (WP)score
Time frame: Weeks 0
Visual Analogue Scale
Time frame: Weeks 0
WOMAC pain (WP)score
Time frame: Weeks 2
WOMAC pain (WP)score
Time frame: Weeks 4
WOMAC pain (WP)score
Time frame: Weeks 12
WOMAC pain (WP)score
Time frame: Weeks 26
Visual Analogue Scale
Time frame: Weeks 2
Visual Analogue Scale
Time frame: Weeks 4
Visual Analogue Scale
Time frame: Weeks 12
Visual Analogue Scale
Time frame: Weeks 26
6 secondary outcomes
WOMAC physical function score (WF)
Time frame: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
Time frame: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
Time frame: Weeks 0,2,4,12,26
Time to walk fifty metre
Time frame: Weeks 0,2,4,12,26
Analgesic intake
Time frame: Weeks 0,2,4,12,26
Side effects of the procedure
Time frame: Weeks 0,2,4,12,26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel K Arden principal investigator
MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular CSI and TI of the knee in people with Knee Osteoarthritis, run by Portsmouth Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC pain (WP)score (time frame: Weeks 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.