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Insurance now covers post-op HA injections, drastically decreasing enrollment.
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.
The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viscosupplementation | Experimental | Hyaluronic acid injection |
|
| Saline injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euflexxa | Device | 4 injections of 2ml of Euflexxa |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tegner Activity Level Scale Score | The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function. | 1 yr postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Pace, MD | Greenville Hospital System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina | 29615 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viscosupplementation | Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa |
| FG001 | Saline Injection | Saline: 4 injections of 3 ml of sterile saline |
| FG002 | No Treatment | No injection - pain/function questionnaires only through 1 year |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Viscosupplementation | Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa |
| BG001 | Saline Injection | Saline: 4 injections of 3 ml of sterile saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tegner Activity Level Scale Score | The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function. | Study ended earlier due to problematic recruitment issues related to a change in insurance payments. Each treatment groups experienced lost to follow up, therefore the number of participants analyzed is smaller than the number of participants enrolled for each group. | Posted | Mean | Full Range | score on a scale | 1 yr postop |
|
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 | Viscosupplementation | Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa |
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Early termination due to new insurance coverage for post-operative knee viscosupplementation leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas Wyland | Steadman Hawkins Clinic of the Carolinas/Greenville Health System | 864-454-7422 | dwyland@ghs.org |
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| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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The two treatment groups were:
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| Saline |
| Other |
4 injections of 3 ml of sterile saline |
|
| BG002 | No Treatment | No injections given |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Saline Injection |
Saline: 4 injections of 3 ml of sterile saline |
| OG002 | No Treatment | Patients did not receive neither viscosupplementation nor saline. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Saline Injection | Saline: 4 injections of 3 ml of sterile saline | 0 | 14 | 0 | 14 |
| EG002 | No Treatment | No injection - pain/function questionnaires only through 1 year | 0 | 8 | 0 | 8 |
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| D017670 |
| Sodium Compounds |