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Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine and Methylprednisolone | Active Comparator | 0.2% ropivacaine and methylprednisolone knee joint injection |
|
| Saline and Methylprednisolone | Experimental | 0.9% normal saline and methylprednisolone knee joint injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 4cc 0.5% ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | 3 months after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale Score | Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. | Pre-injection, immediately post-injection, 2 weeks, 3 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob L Sellon, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine and Methylprednisolone | 0.2% ropivacaine and methylprednisolone knee joint injection |
| FG001 | Saline and Methylprednisolone | 0.9% normal saline and methylprednisolone knee joint injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine and Methylprednisolone | 0.2% ropivacaine and methylprednisolone knee joint injection |
| BG001 | Saline and Methylprednisolone | 0.9% normal saline and methylprednisolone knee joint injection |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Posted | Mean | Standard Deviation | units on a scale | 3 months after the injection |
|
3 months
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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 | Ropivacaine and Methylprednisolone | 0.2% ropivacaine and methylprednisolone knee joint injection |
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Lack of power due to lower than expected enrollment; follow-up was limited to 3 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Sellon | Mayo Clinic | 507-255-1141 | sellon.jacob@mayo.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal saline | Drug | 4cc of sterile normal saline (0.9%) |
|
|
| Methylprednisolone | Drug | 1cc 40mg methylprednisolone |
|
|
| Tegner Activity Level Scale |
The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport. |
| baseline (pre-injection), 2 weeks, 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Knee Effusion | Knee effusion, colloquially known as water on the knee, occurs when excess fluid accumulates in or around the knee joint. | Count of Participants | Participants |
|
0.9% normal saline and methylprednisolone knee joint injection |
|
|
| Secondary | Pain Scale Score | Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. | Posted | Mean | Standard Deviation | units on a scale | Pre-injection, immediately post-injection, 2 weeks, 3 months |
|
|
|
| Secondary | Tegner Activity Level Scale | The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport. | Posted | Mean | Standard Deviation | units on a scale | baseline (pre-injection), 2 weeks, 3 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Saline and Methylprednisolone | 0.9% normal saline and methylprednisolone knee joint injection | 0 | 14 | 0 | 14 | 0 | 14 |
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| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Immediately Post-injection Activity |
|
| Immediately Post-injection Rest |
|
| 2 Weeks Activity |
|
| 2 Weeks Rest |
|
| 3 Months Activity |
|
| 3 Months Rest |
|
| 3 months |
|