Knee Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, ultrasound, sonography, injection
Brief summary
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.
Interventions
PROCEDUREJoint line ultrasound
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.
PROCEDUREJoint line 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 not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.
PROCEDURESuprapatellar ultrasound guided
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.
PROCEDURESuprapatellar Landmark
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.
Sponsors
American Medical Society for Sports Medicine (AMSSM)
Andrews Research & Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18 to 90 * Clinician determined need for intra-articular knee injection * Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Knee Injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Satisfaction Score at 3 Months Post Injection | 3 month follow-up appointment following 3rd injection | Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Pre-Injection and 3 month follow-up appointment following 3rd 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited through individual physician practices.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 16 |
| 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. | 14 |
| 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. | 14 |
| Total | 63 |
Baseline characteristics
| Characteristic | Joint Line Landmark | Suprapatellar Ultrasound Guided | Suprapatellar Landmark | Total | Joint Line Ultrasound |
|---|---|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 12.1 | 71.4 years STANDARD_DEVIATION 9.6 | 68.8 years STANDARD_DEVIATION 9.5 | 67.6 years STANDARD_DEVIATION 10.9 | 64.7 years STANDARD_DEVIATION 12.2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 14 participants | 14 participants | 63 participants | 19 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 8 Participants | 41 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 6 Participants | 22 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 16 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 19 | 0 / 16 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 19 | 0 / 16 | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: Procedure visit 3 (3-4 weeks after 1st injection)
Population: Number of patients in each group with successful injections into the knee joint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Joint Line Ultrasound | Number of Participants With Successful Knee Injection | 17 Participants |
| Joint Line Landmark | Number of Participants With Successful Knee Injection | 14 Participants |
| Suprapatellar Ultrasound Guided | Number of Participants With Successful Knee Injection | 13 Participants |
| Suprapatellar Landmark | Number of Participants With Successful Knee Injection | 7 Participants |
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.
Time frame: 3 month follow-up appointment following 3rd injection
Population: ANOVA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Joint Line Ultrasound | Procedural Satisfaction Score at 3 Months Post Injection | 7.84 units on a scale | Standard Deviation 3.13 |
| Joint Line Landmark | Procedural Satisfaction Score at 3 Months Post Injection | 8.71 units on a scale | Standard Deviation 2.2 |
| Suprapatellar Ultrasound Guided | Procedural Satisfaction Score at 3 Months Post Injection | 7.14 units on a scale | Standard Deviation 3.33 |
| Suprapatellar Landmark | Procedural Satisfaction Score at 3 Months Post Injection | 8.29 units on a scale | Standard Deviation 2.76 |
p-value: 0.527ANOVA
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.
Time frame: Pre-Injection and 3 month follow-up appointment following 3rd injection
Population: Mean WOMAC score Pre-Injection and at 3-months post injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Joint Line Ultrasound | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Post-Injection | 23.42 units on a scale | Standard Deviation 25.88 |
| Joint Line Ultrasound | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Pre-Injection | 48.05 units on a scale | Standard Deviation 30.92 |
| Joint Line Landmark | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Post-Injection | 31.07 units on a scale | Standard Deviation 28.63 |
| Joint Line Landmark | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Pre-Injection | 43.75 units on a scale | Standard Deviation 27.53 |
| Suprapatellar Ultrasound Guided | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Pre-Injection | 53.15 units on a scale | Standard Deviation 25.25 |
| Suprapatellar Ultrasound Guided | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Post-Injection | 32.5 units on a scale | Standard Deviation 27.02 |
| Suprapatellar Landmark | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Post-Injection | 28.57 units on a scale | Standard Deviation 20.7 |
| Suprapatellar Landmark | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score | Pre-Injection | 47.61 units on a scale | Standard Deviation 30.71 |
p-value: 0.749ANOVA