Knee OsteoarthritisPRISMMNCT03293238
Ultrasound Guided Knee Injections in Musculoskeletal Medicine
A study testing Joint line ultrasound, Joint line landmark and Suprapatellar ultrasound guided in people with Knee Osteoarthritis, run by Andrews Research & Education Foundation at 1 site in United States.
Trial summary
This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Joint line ultrasound, Joint line landmark and Suprapatellar ultrasound guided
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2011to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 90
- Clinician determined need for intra-articular knee injection
- Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale
Who cannot join
- Allergy to contrast dye, shellfish
- Allergy to egg product or hyaluronate
- Allergy to lidocaine
- Localized skin infection at planned site of injection
- Inability to complete follow-up phone call three months following the injection
- Viscosupplementation injection within 6 months of the current evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
About this study
Official title: Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections
This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.
Read the detailed description
This study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. Historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. Newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.
- Conditions
- Knee Osteoarthritis
- Being tested
- Joint line ultrasound, Joint line landmark, Suprapatellar ultrasound guided, Suprapatellar Landmark
- Keywords
- knee, osteoarthritis, ultrasound, sonography, injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint line ultrasoundProcedure or surgery
Also called JLUS
Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.
Joint line landmarkProcedure or surgery
Also called JLL
Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.
Suprapatellar ultrasound guidedProcedure or surgery
Also called SPUS
Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.
Suprapatellar LandmarkProcedure or surgery
Also called SPL
Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.
| Study group | Role | What they receive |
|---|---|---|
| Joint Line Ultrasound | Active comparator | Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. Receives: Procedure: Joint line ultrasound |
| Joint Line Landmark | Sham comparator | Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. Receives: Procedure: Joint line landmark |
| Suprapatellar Ultrasound Guided | Active comparator | Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. Receives: Procedure: Suprapatellar ultrasound guided |
| Suprapatellar Landmark | Sham comparator | Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance. Receives: Procedure: Suprapatellar Landmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Knee Injection
To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.
Measured: Procedure visit 3 (3-4 weeks after 1st injection)
Secondary outcomes (2)
Procedural Satisfaction Score at 3 Months Post Injection
Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
Measured: 3 month follow-up appointment following 3rd injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Pre-Injection and 3 month follow-up appointment following 3rd injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start3 Nov 2011
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Model description
- Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Society for Sports Medicine
- Responsible party
- Sponsor
- Investigators
- Joshua Hackel, MD, Principal investigator, Andrews Institute for Orthopaedic & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293238
- Sponsor's protocol ID
- PRISMM-Knee
- Acronym
- PRISMM
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2017
- Last updated
- 8 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
PubMed 11156538Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.
PubMed 12208907Wiler JL, Costantino TG, Filippone L, Satz W. Comparison of ultrasound-guided and standard landmark techniques for knee arthrocentesis. J Emerg Med. 2010 Jul;39(1):76-82. doi: 10.1016/j.jemermed.2008.05.012. Epub 2008 Dec 5.
PubMed 19062223Esenyel C, Demirhan M, Esenyel M, Sonmez M, Kahraman S, Senel B, Ozdes T. Comparison of four different intra-articular injection sites in the knee: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):573-7. doi: 10.1007/s00167-006-0231-6. Epub 2006 Dec 6.
PubMed 17149645Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
PubMed 14760802Berkoff DJ, Miller LE, Block JE. Clinical utility of ultrasound guidance for intra-articular knee injections: a review. Clin Interv Aging. 2012;7:89-95. doi: 10.2147/CIA.S29265. Epub 2012 Mar 20.
PubMed 22500117Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
PubMed 20222114Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.
PubMed 19854960Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.
PubMed 20531157
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections
- ClinicalTrials.gov ID
- NCT03293238
- Acronym / sponsor ID
- PRISMM / PRISMM-Knee
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, ultrasound, sonography, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- American Medical Society for Sports Medicine
- Study start
- 3 Nov 2011 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.
Detailed description
This study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. Historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. Newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
| Arm | Type | Receives |
|---|---|---|
| Joint Line Ultrasound | Active comparator | Procedure: Joint line ultrasoundPatients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. |
| Joint Line Landmark | Sham comparator | Procedure: Joint line landmarkPatients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. |
| Suprapatellar Ultrasound Guided | Active comparator | Procedure: Suprapatellar ultrasound guidedPatients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. |
| Suprapatellar Landmark | Sham comparator | Procedure: Suprapatellar LandmarkPatients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age 18 to 90
- Clinician determined need for intra-articular knee injection
- Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale
Key exclusion criteria (6 listed)
- Allergy to contrast dye, shellfish
- Allergy to egg product or hyaluronate
- Allergy to lidocaine
- Localized skin infection at planned site of injection
- Inability to complete follow-up phone call three months following the injection
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 |
|---|---|---|
| Joint line ultrasoundAlso: JLUSPatients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance. | Procedure or surgery | Joint Line Ultrasound |
| Joint line landmarkAlso: JLLPatients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician. | Procedure or surgery | Joint Line Landmark |
| Suprapatellar ultrasound guidedAlso: SPUSPatients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch. | Procedure or surgery | Suprapatellar Ultrasound Guided |
| Suprapatellar LandmarkAlso: SPLPatients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch. | Procedure or surgery | Suprapatellar Landmark |
Primary outcome
Number of Participants With Successful Knee Injection
Time frame: Procedure visit 3 (3-4 weeks after 1st injection)
To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.
2 secondary outcomes
Procedural Satisfaction Score at 3 Months Post Injection
Time frame: 3 month follow-up appointment following 3rd injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: Pre-Injection and 3 month follow-up appointment following 3rd injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11156538Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
- Background: PubMed 12208907Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.
- Background: PubMed 19062223Wiler JL, Costantino TG, Filippone L, Satz W. Comparison of ultrasound-guided and standard landmark techniques for knee arthrocentesis. J Emerg Med. 2010 Jul;39(1):76-82. doi: 10.1016/j.jemermed.2008.05.012. Epub 2008 Dec 5.
- Background: PubMed 17149645Esenyel C, Demirhan M, Esenyel M, Sonmez M, Kahraman S, Senel B, Ozdes T. Comparison of four different intra-articular injection sites in the knee: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):573-7. doi: 10.1007/s00167-006-0231-6. Epub 2006 Dec 6.
- Background: PubMed 14760802Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
- Background: PubMed 22500117Berkoff DJ, Miller LE, Block JE. Clinical utility of ultrasound guidance for intra-articular knee injections: a review. Clin Interv Aging. 2012;7:89-95. doi: 10.2147/CIA.S29265. Epub 2012 Mar 20.
- Background: PubMed 20222114Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
- Background: PubMed 19854960Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.
- Background: PubMed 20531157Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.
- Individual participant dataSharing planned: No
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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.
Joshua Hackel, MD principal investigator
Andrews Institute for Orthopaedic & Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint line ultrasound, Joint line landmark and Suprapatellar ultrasound guided in people with Knee Osteoarthritis, run by Andrews Research & Education Foundation 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 3 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 8 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Knee Injection (time frame: Procedure visit 3 (3-4 weeks after 1st injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293238, which also lists 9 linked publications.
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 8 Aug 2022.