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The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Only | Active Comparator | Home exercise program. |
|
| Brace Only | Active Comparator | Reaction Web brace. |
|
| Bracing + Exercises | Active Comparator | Reaction Web brace and home exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Only | Other | This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pain Using the Visual Analog Scale | The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms. | Baseline and 3-month Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quadriceps Force | Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month. | Baseline and 3-month Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank R Kolisek, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoIndy | Greenwood | Indiana | 46143 | United States |
Individual participant data will not be shared, only averages and summaries where all participant data is combined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Only | Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. |
| FG001 | Brace Only | Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. |
| FG002 | Bracing + Exercises | Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Only | Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. |
| BG001 | Brace Only |
| 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 | Assessment of Pain Using the Visual Analog Scale | The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms. | Change from baseline reported in table | Posted | Mean | Full Range | score on a scale | Baseline and 3-month Visit |
|
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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 | Exercise Only | Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Kolisek | OrthoIndy | 3178845160 | fkolisek@orthoindy.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001915 | Braces |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Brace Only | Device | This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. |
|
| Bracing + Exercises | Other | This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. |
|
Reaction Web brace.
Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
| BG002 | Bracing + Exercises | Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Laterality | Count of Participants | Participants |
|
| OG001 | Brace Only | Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. |
| OG002 | Bracing + Exercises | Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. |
|
|
| Secondary | Change in Quadriceps Force | Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month. | Normalized quadriceps force values reported in data table by study arm. | Posted | Mean | Full Range | Newtons (N) | Baseline and 3-month Visit |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Brace Only | Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. | 0 | 19 | 0 | 19 |
| EG002 | Bracing + Exercises | Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. | 0 | 14 | 0 | 14 |
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| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Male |
|
| Left |
|