Anterior Knee Pain
Conditions
Keywords
Knee Brace Effectiveness
Brief summary
This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes related to pain and function.
Detailed description
Patients in this study have been identified as good candidates by their physicians. As the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. The study was designed to present the least risk possible consistent with sound research design. Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford. These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.
Interventions
DEVICETri-Compartment Unloader Brace
Knee brace that is designed to reduce compressive forces on all three compartments of the knee.
Sponsors
Stanford University
Spring Loaded Tech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No one will be masked/blinded in this study.
Intervention model description
Two groups. One brace (intervention) group and one no brace (control) group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Anterior knee pain that worsens when the knee is flexed and bearing weight 2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI 3. Kellgren and Lawrence grade 0-3 of PF joint 4. Able to wear the TCU knee brace for a minimum of 3 hours per day 5. Over 18 years old, can understand written English 6. Coronal knee alignment within 7 degrees of neutral 7. Must be able to fit within an off-the-shelf knee brace size provided by Company 8. Must complete physical therapy through Stanford
Exclusion criteria
1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year 2. Use of another brace designed to unload the knee or manage knee pain during the study 3. Varus/Valgus joint alignment \> 7 degrees 4. Inability to be fit properly in an off-the-shelf brace provided by the Company 5. BMI \>40 6. Bilateral knee symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 6-weeks, and 3-months | Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. |
| Pain Visual Analog Scale (VAS) | Baseline, 6-weeks, and 3-months | Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (EQ-5D) | Baseline, 6-weeks, and 3-months | Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems. The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are then scaled to a score of 0 to 100 (high scores correspond to higher health related quality of life). |
| Lower Extremity Activity Scale (LEAS) | Baseline, 6-weeks, and 3-months | Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients answer 20 questions, choosing from 18 options of activity levels (0 = no activity, to 18 = college/professional athlete level of activity). Individual scores are summed and averaged to create the overall score (range: 0 to 18, with highest scores corresponding to highest level of activity). |
| Quadricep Strength (Girth) | Baseline through 3-months post-intervention | Using a biodex to measure quadriceps strength. Number of participants achieving a minimal clinically important difference (MCID) in quadriceps strength, defined as a greater than or equal to 10% increase from baseline. |
| Effusion Grade | Baseline through 3-months post-intervention | Number of participants with effusion, by grade. Checking how much fluid is around the knee. There are different grades, ranging from Grade 1 to Grade 5. Grade 1 means no fluid-wave while performing a downward stroke whereas Grade 5 means excess of fluid that makes it impossible to stroke the medial fluid away. |
| Painful Crepitus With Deep Knee Flexion | Baseline through 3 months post-intervention | Number of participants with painful crepitus at deep knee flexion, which is when there is a sensation or noise when you move a joint. |
| Knee Range of Motion | Baseline through 3 months post-intervention | Number of participants with full or deficient range of motion (ROM). Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg. Deficient ROM is nonzero at full extension and/or \< 130° flexion. Full ROM is defined as 0° extension and 130° flexion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSeth L Sherman, MD
Stanford University
Participant flow
Pre-assignment details
20 participants signed informed consent, and 14 were randomized
Participants by arm
| Arm | Count |
|---|---|
| Experimental: TCU Bracing Participants will be instructed to wear a TCU knee brace (Levitation 2) for a minimum of 3 hours per day during activities of daily living and undergo standard of care rehabilitation protocol. | 8 |
| Control Participants will undergo standard of care rehabilitation protocol only. | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Control | Total | Experimental: TCU Bracing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 14 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) patient-reported outcome questionnaire; responses are scaled to a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time frame: Baseline, 6-weeks, and 3-months
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TCU bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline | 61.91 score on a scale | Standard Deviation 14.42 |
| Experimental: TCU bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 weeks | 71.17 score on a scale | Standard Deviation 8.87 |
| Experimental: TCU bracing | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 3 months | 72.39 score on a scale | Standard Deviation 11.19 |
| Control | Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline | 72.59 score on a scale | Standard Deviation 15.72 |
| Control | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 weeks | 85.99 score on a scale | Standard Deviation 16.6 |
| Control | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 3 months | 86.76 score on a scale | Standard Deviation 13.39 |
Primary
Pain Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is rated on a scale of 0 to 100 where 0 means no pain and 100 means severe pain.
Time frame: Baseline, 6-weeks, and 3-months
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TCU bracing | Pain Visual Analog Scale (VAS) | Baseline | 20 score on a scale | Standard Deviation 0 |
| Experimental: TCU bracing | Pain Visual Analog Scale (VAS) | 6 weeks | 12.61 score on a scale | Standard Deviation 7.52 |
| Experimental: TCU bracing | Pain Visual Analog Scale (VAS) | 3 months | 12.33 score on a scale | Standard Deviation 9.71 |
| Control | Pain Visual Analog Scale (VAS) | 3 months | 15.5 score on a scale | Standard Deviation 17.92 |
| Control | Pain Visual Analog Scale (VAS) | Baseline | 36.17 score on a scale | Standard Deviation 23.37 |
| Control | Pain Visual Analog Scale (VAS) | 6 weeks | 8.42 score on a scale | Standard Deviation 10.48 |
Secondary
Effusion Grade
Checking how much fluid is around the knee. There are different grades. Grade 1 means no fluid-wave while performing a downward stroke whereas Grade 5 means excess of fluid that makes it impossible to stroke the medial fluid away.
Time frame: Baseline; 6-weeks and 3-months post-intervention
Secondary
Knee Range of Motion
Knee range of motion is measured at 0º extension (completely straight leg) to 130º, a fully flexed leg.
Time frame: Baseline; 6-weeks and 3-months post-intervention
Secondary
Lower Extremity Activity Scale (LEAS)
Lower Extremity Activity Scale (LEAS) measures daily physical activity by having patients answer 20 questions, choosing from 18 options of activity levels (0 = no activity, to 18 = college/professional athlete level of activity). Individual scores are summed and averaged to create the overall score (range: 0 to 18, with highest scores corresponding to highest level of activity).
Time frame: Baseline, 6-weeks, and 3-months
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TCU bracing | Lower Extremity Activity Scale (LEAS) | Baseline | 9 score on a scale | Standard Deviation 5.66 |
| Experimental: TCU bracing | Lower Extremity Activity Scale (LEAS) | 6 Weeks | 13 score on a scale | Standard Deviation 4.2 |
| Experimental: TCU bracing | Lower Extremity Activity Scale (LEAS) | 3 Months | 14 score on a scale | Standard Deviation 3.54 |
| Control | Lower Extremity Activity Scale (LEAS) | Baseline | 12.3 score on a scale | Standard Deviation 5.7 |
| Control | Lower Extremity Activity Scale (LEAS) | 6 Weeks | 12 score on a scale | Standard Deviation 4.5 |
| Control | Lower Extremity Activity Scale (LEAS) | 3 Months | 11.25 score on a scale | Standard Deviation 4.57 |
Secondary
Painful Crepitus With Deep Knee Flexion
Painful crepitus is when there is a sensation or noise when you move a joint.
Time frame: Baseline; 6-weeks and 3-months post-intervention
Secondary
Quadricep Strength (Girth)
Using a biodex to measure quad strength.
Time frame: Baseline; 6-weeks and 3-months post-intervention
Secondary
Quality of Life (EQ-5D)
Quality of life (EQ-5D) has 5 response levels where level 1 equates to no problems and level 5 equates to severe problems. The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses are then scaled to a score of 0 to 100 (high scores correspond to higher health related quality of life).
Time frame: Baseline, 6-weeks, and 3-months
Population: Participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TCU bracing | Quality of Life (EQ-5D) | Baseline | 67.5 score on a scale | Standard Deviation 3.54 |
| Experimental: TCU bracing | Quality of Life (EQ-5D) | 6 Weeks | 74.83 score on a scale | Standard Deviation 14.32 |
| Experimental: TCU bracing | Quality of Life (EQ-5D) | 3 Months | 85.8 score on a scale | Standard Deviation 12.89 |
| Control | Quality of Life (EQ-5D) | Baseline | 79.8 score on a scale | Standard Deviation 12.76 |
| Control | Quality of Life (EQ-5D) | 6 Weeks | 71.0 score on a scale | Standard Deviation 32.99 |
| Control | Quality of Life (EQ-5D) | 3 Months | 69.0 score on a scale | Standard Deviation 26.8 |