An interventional study of Joint line ultrasound and Joint line landmark in Knee Osteoarthritis, sponsored by Andrews Research & Education Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by Andrews Research & Education Foundation · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
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
Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.
Procedure: Suprapatellar Landmark
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
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
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
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
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.
Time frame: Procedure visit 3 (3-4 weeks after 1st injection)
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.
Time frame: 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.
Time frame: Pre-Injection and 3 month follow-up appointment following 3rd injection
Patients were recruited through individual physician practices.
| Milestone | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark |
|---|---|---|---|---|
| Started | 19 | 16 | 14 | 14 |
| Completed | 19 | 16 | 14 | 14 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark |
|---|---|---|---|---|
| Number of Participants With Successful Knee Injection | 17 | 14 | 13 | 7 |
Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
| units on a scale | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark |
|---|---|---|---|---|
| Procedural Satisfaction Score at 3 Months Post Injection | 7.84 ± 3.13 | 8.71 ± 2.20 | 7.14 ± 3.33 | 8.29 ± 2.76 |
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.
| units on a scale | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark |
|---|---|---|---|---|
| Pre-Injection | 48.05 ± 30.92 | 43.75 ± 27.53 | 53.15 ± 25.25 | 47.61 ± 30.71 |
| Post-Injection | 23.42 ± 25.88 | 31.07 ± 28.63 | 32.5 ± 27.02 | 28.57 ± 20.70 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Joint Line Ultrasound | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Joint Line Landmark | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Suprapatellar Ultrasound Guided | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Suprapatellar Landmark | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark | Total |
|---|---|---|---|---|---|
| Mean | 64.7 ± 12.2 | 65.3 ± 12.1 | 71.4 ± 9.6 | 68.8 ± 9.5 | 67.6 ± 10.9 |
| Sex: Female, Male(Participants) | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark | Total |
|---|---|---|---|---|---|
| Female | 12 | 9 | 12 | 8 | 41 |
| Male | 7 | 7 | 2 | 6 | 22 |
| Race and Ethnicity Not Collected(Participants) | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Joint Line Ultrasound | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark | Total |
|---|---|---|---|---|---|
| United States | 19 | 16 | 14 | 14 | 63 |
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Andrews Research & Education Foundation