Ultrasound Guided Knee Injections in Musculoskeletal Medicine

NCT03293238 | Completed Results

• 1 other identifier: PRISMM-Knee
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis; ultrasound; sonography; injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Procedure visit 3 (3-4 weeks after 1st injection)

Secondary Outcomes (2)

• Procedural Satisfaction Score at 3 Months Post Injection

  3 month follow-up appointment following 3rd injection

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

  Pre-Injection and 3 month follow-up appointment following 3rd injection

Study Arms (4)

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.

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.

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.

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.

Procedure: Suprapatellar Landmark

Interventions

Joint line ultrasound PROCEDURE

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.

Also known as: JLUS

Joint Line Ultrasound

Joint line landmark PROCEDURE

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.

Also known as: JLL

Joint Line Landmark

Suprapatellar ultrasound guided PROCEDURE

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.

Also known as: SPUS

Suprapatellar Ultrasound Guided

Suprapatellar Landmark PROCEDURE

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.

Also known as: SPL

Suprapatellar Landmark

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 to 90
• Clinician determined need for intra-articular knee injection
• Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• American Medical Society for Sports Medicine (AMSSM): collaborator

Study Sites (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (9)

• 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.

  PMID: 11156538 BACKGROUND

• Jackson 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.

  PMID: 12208907 BACKGROUND

• Wiler 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.

  PMID: 19062223 BACKGROUND

• Esenyel 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.

  PMID: 17149645 BACKGROUND

• Naredo 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.

  PMID: 14760802 BACKGROUND

• Berkoff 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.

  PMID: 22500117 BACKGROUND

• Cunnington 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.

  PMID: 20222114 BACKGROUND

• Im 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.

  PMID: 19854960 BACKGROUND

• Hong 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.

  PMID: 20531157 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Joshua Hackel
• Organization: Andrews Research & Education Foundation

jghackelmd@yahoo.com

850-916-8796

Study Officials

• Joshua Hackel, MD

  Andrews Institute for Orthopaedic & Sports Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: November 3, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 8, 2022
• Results First Posted: November 6, 2019

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)