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| Name | Class |
|---|---|
| American Medical Society for Sports Medicine | OTHER |
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This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Suprapatellar Landmark | Sham Comparator | Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month follow-up appointment following 3rd injection |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Hackel, MD | Andrews Institute for Orthopaedic & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Research & Education Foundation | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11156538 | Background | 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. | |
| 12208907 | 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. |
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Sixty-three patients were enrolled and randomized into four groups: Group 1: Joint Line Ultrasound Guided (n= 19), Group 2: Joint Line Landmark Based (sham Ultrasound) (n= 16), Group 3: Suprapatellar Ultrasound Guided (n= 14), Group 4: Suprapatellar Landmark Based (sham Ultrasound) (n= 14). One patient's radiographic imaging was lost.
Patients were recruited through individual physician practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Joint Line Ultrasound | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance. |
| FG001 | Joint Line Landmark | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician. |
| FG002 | Suprapatellar Ultrasound Guided | Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was 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 was made within the suprapatellar pouch. |
| FG003 | Suprapatellar Landmark | Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance. Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Joint Line Ultrasound | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of patients in each group with successful injections into the knee joint. | Posted | Count of Participants | Participants | Procedure visit 3 (3-4 weeks after 1st injection) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Joint Line Ultrasound | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up. Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Hackel | Andrews Research & Education Foundation | 850-916-8796 | jghackelmd@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2011 | Oct 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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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.
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| 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. |
|
|
| 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. |
|
|
| 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. |
|
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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. |
| Pre-Injection and 3 month follow-up appointment following 3rd injection |
| 19062223 | 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. |
| 17149645 | 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. |
| 14760802 | 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. |
| 22500117 | 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. |
| 20222114 | 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. |
| 19854960 | 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. |
| 20531157 | 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. |
| BG001 | Joint Line Landmark | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician. |
| BG002 | Suprapatellar Ultrasound Guided | Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was 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 was made within the suprapatellar pouch. |
| BG003 | Suprapatellar Landmark | Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance. Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Joint Line Landmark | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician. |
| OG002 | Suprapatellar Ultrasound Guided | Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was 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 was made within the suprapatellar pouch. |
| OG003 | Suprapatellar Landmark | Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance. Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch. |
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| Secondary | 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. | ANOVA | Posted | Mean | Standard Deviation | units on a scale | 3 month follow-up appointment following 3rd injection |
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| Secondary | 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. | Mean WOMAC score Pre-Injection and at 3-months post injection. | Posted | Mean | Standard Deviation | units on a scale | Pre-Injection and 3 month follow-up appointment following 3rd injection |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Joint Line Landmark | Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up. Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Suprapatellar Ultrasound Guided | Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance. Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was 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 was made within the suprapatellar pouch. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Suprapatellar Landmark | Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance. Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Male |
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| Post-Injection |
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