Trial Outcomes & Findings for Ultrasound Guided Knee Injections in Musculoskeletal Medicine (NCT NCT03293238)
NCT ID: NCT03293238
Last Updated: 2022-08-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Procedure visit 3 (3-4 weeks after 1st injection)
Results posted on
2022-08-08
Participant Flow
Patients were recruited through individual physician practices.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
14
|
14
|
|
Overall Study
COMPLETED
|
19
|
16
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Joint Line Ultrasound
n=19 Participants
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.
|
Joint Line Landmark
n=16 Participants
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.
|
Suprapatellar Ultrasound Guided
n=14 Participants
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.
|
Suprapatellar Landmark
n=14 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 12.2 • n=19 Participants
|
65.3 years
STANDARD_DEVIATION 12.1 • n=16 Participants
|
71.4 years
STANDARD_DEVIATION 9.6 • n=14 Participants
|
68.8 years
STANDARD_DEVIATION 9.5 • n=14 Participants
|
67.6 years
STANDARD_DEVIATION 10.9 • n=63 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=19 Participants
|
9 Participants
n=16 Participants
|
12 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
41 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=19 Participants
|
7 Participants
n=16 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
22 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
16 participants
n=16 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
63 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: Procedure visit 3 (3-4 weeks after 1st injection)Population: Number of patients in each group with successful injections into the knee joint.
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.
Outcome measures
| Measure |
Joint Line Ultrasound
n=19 Participants
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.
|
Joint Line Landmark
n=16 Participants
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.
|
Suprapatellar Ultrasound Guided
n=14 Participants
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.
|
Suprapatellar Landmark
n=14 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Successful Knee Injection
|
17 Participants
|
14 Participants
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 month follow-up appointment following 3rd injectionPopulation: ANOVA
Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
Outcome measures
| Measure |
Joint Line Ultrasound
n=19 Participants
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.
|
Joint Line Landmark
n=16 Participants
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.
|
Suprapatellar Ultrasound Guided
n=14 Participants
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.
|
Suprapatellar Landmark
n=14 Participants
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.
|
|---|---|---|---|---|
|
Procedural Satisfaction Score at 3 Months Post Injection
|
7.84 units on a scale
Standard Deviation 3.13
|
8.71 units on a scale
Standard Deviation 2.20
|
7.14 units on a scale
Standard Deviation 3.33
|
8.29 units on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Pre-Injection and 3 month follow-up appointment following 3rd injectionPopulation: Mean WOMAC score Pre-Injection and at 3-months post injection.
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.
Outcome measures
| Measure |
Joint Line Ultrasound
n=19 Participants
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.
|
Joint Line Landmark
n=16 Participants
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.
|
Suprapatellar Ultrasound Guided
n=14 Participants
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.
|
Suprapatellar Landmark
n=14 Participants
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.
|
|---|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Pre-Injection
|
48.05 units on a scale
Standard Deviation 30.92
|
43.75 units on a scale
Standard Deviation 27.53
|
53.15 units on a scale
Standard Deviation 25.25
|
47.61 units on a scale
Standard Deviation 30.71
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Post-Injection
|
23.42 units on a scale
Standard Deviation 25.88
|
31.07 units on a scale
Standard Deviation 28.63
|
32.5 units on a scale
Standard Deviation 27.02
|
28.57 units on a scale
Standard Deviation 20.70
|
Adverse Events
Joint Line Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Joint Line Landmark
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suprapatellar Ultrasound Guided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suprapatellar Landmark
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joshua Hackel
Andrews Research & Education Foundation
Phone: 850-916-8796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place