OsteoarthritisPhase 3NCT02092246
Ultrasound Guided vs Unguided Intra-articular Knee Injections
A Phase 3 study testing Ultrasound machine and Unguided injection in people with Osteoarthritis and Inflammatory Arthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Inflammatory Arthritis
- What is being tested?
- Ultrasound machine and Unguided injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2016
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Who cannot join
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
- History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.
Read the detailed description
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
- Conditions
- Osteoarthritis, Inflammatory Arthritis
- Being tested
- Ultrasound machine, Unguided injection
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound machineDevice
Also called Philips CX-50 Ultrasound Machine, FUJUFILM SonoSite X-Porte Ultrasound Machine
Use of ultrasound machine guidance for accurate needle placement into the knee joint
Unguided injectionDevice
Also called Philips CX-50 Ultrasound Machine, FUJIFILM SonoSite X-Porte Ultrasound Machine
Needle placement will take place without ultrasound machine guidance
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Machine Guided Injection | Active comparator | Use of ultrasound machine guidance in needle placement into the knee joint Receives: Device: Ultrasound machine |
| Unguided Injection | Active comparator | Needle placement performed without ultrasound machine guidance Receives: Device: Unguided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the initial needle placement into the knee joint.
The number of participants with accurate initial needle placement into the knee joint
Measured: During the initial needle placement, which can take 1-5 minutes
Secondary outcomes (1)
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't
Measured: 30 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: Difficulty enrolling subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Pingree, Mayo Clinic
- Investigators
- Matthew Pingree, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092246
- Sponsor's protocol ID
- 13-008328
- Status last verified
- Oct 2015
- First submitted
- 13 Mar 2014
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
- ClinicalTrials.gov ID
- NCT02092246
- Acronym / sponsor ID
- 13-008328
- Conditions
- Osteoarthritis, Inflammatory Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty enrolling subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 20 Mar 2014 (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.
To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.
Detailed description
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Machine Guided Injection | Active comparator | Device: Ultrasound machineUse of ultrasound machine guidance in needle placement into the knee joint |
| Unguided Injection | Active comparator | Device: Unguided injectionNeedle placement performed without ultrasound machine guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Key exclusion criteria (6 listed)
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
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 |
|---|---|---|
| Ultrasound machineAlso: Philips CX-50 Ultrasound Machine, FUJUFILM SonoSite X-Porte Ultrasound MachineUse of ultrasound machine guidance for accurate needle placement into the knee joint | Device | Ultrasound Machine Guided Injection |
| Unguided injectionAlso: Philips CX-50 Ultrasound Machine, FUJIFILM SonoSite X-Porte Ultrasound MachineNeedle placement will take place without ultrasound machine guidance | Device | Unguided Injection |
Primary outcome
Accuracy of the initial needle placement into the knee joint.
Time frame: During the initial needle placement, which can take 1-5 minutes
The number of participants with accurate initial needle placement into the knee joint
1 secondary outcome
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
Time frame: 30 minutes post injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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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.
Matthew Pingree, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound machine and Unguided injection in people with Osteoarthritis and Inflammatory Arthritis, run by Mayo Clinic at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of the initial needle placement into the knee joint. (time frame: During the initial needle placement, which can take 1-5 minutes). 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 15 Oct 2015.