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Low enrollment.
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Minnesota Medical Foundation | OTHER |
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This study is looking at the efficacy of a sloped insole in patients with knee osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain, decreased use of over the counter analgesics, and a clinically important improvement in the Womac pain and stiffness scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wedge Insert | Experimental | Patients will receive a wedge insert |
|
| Flat insert | Placebo Comparator | Patients will receive a flat insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wedge Insert | Other |
| ||
| Flat Insert |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Baseline |
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | 6 weeks |
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | 3 months |
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | 6 months |
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | 9 months |
| Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. |
| Measure | Description | Time Frame |
|---|---|---|
| Kellgren and Lawrence Classification of Osteoarthritis of Knee | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). | Baseline |
| Kellgren and Lawrence Classification of Osteoarthritis of Knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wedge Insert | Patients will receive a wedge insert Wedge Insert |
| FG001 | Flat Insert | Patients will receive a flat insert Flat Insert |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wedge Insert | Patients will receive a wedge insert Wedge Insert |
| BG001 | Flat Insert | Patients will receive a flat insert Flat Insert |
| 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 | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | Baseline |
|
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 | Wedge Insert | Patients will receive a wedge insert Wedge Insert | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Pain | Systematic Assessment | Patient experienced increased pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Reams | TRIA Orthopaedic Center | 952-806-5329 | megan.reams@tria.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2014 | Aug 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| 12 months |
X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).
| 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | 6 weeks |
|
|
|
| Primary | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | 3 months |
|
|
|
| Primary | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | 6 months |
|
|
|
| Primary | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | 9 months |
|
|
|
| Primary | Patient Reported Function and Pain | Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform. | Posted | Mean | Full Range | score on a scale 0-10 (normal) | 12 months |
|
|
|
| Secondary | Kellgren and Lawrence Classification of Osteoarthritis of Knee | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). | Data was not gathered due to pre-mature termination of the study. | Posted | Baseline |
|
|
| Secondary | Kellgren and Lawrence Classification of Osteoarthritis of Knee | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). | Data was not gathered due to pre-mature termination of the study. | Posted | 6 months |
|
|
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Flat Insert | Patients will receive a flat insert Flat Insert | 0 | 3 | 0 | 3 | 0 | 3 |
|
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