Knee Osteoarthritis
Conditions
Brief summary
The goals of treating knee osteoarthritis (OA) is to improve or maintain quality of life, mobility and function, pain relief, and improve inflammation. The different treatment options for knee OA have been extensively studied and implemented, but the optimum treatment is still undecided. There is a belief that anti-inflammatory sleeve technology may be beneficial in treating knee OA. The purpose of this study is to determine the clinical effects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.
Detailed description
Standard knee compression sleeves have been described throughout literature to provide benefits in pain and functional outcomes through support of the ligamentous structures. Bracing is both an effective and economical treatment for osteoarthritis and serves as a crucial option in the treatment of knee OA to aid in both delaying surgery and as options for young patients, or patients that are not ideal surgical candidates. Although knee sleeves are commonly utilized treatment modalities, there is a significant paucity of literature on the effects of thermo-active braces in the treatment of knee OA. This investigation will examine this non-operative treatment modality and study it effect for the treatment of knee OA specifically by investigating the Reparel Knee Sleeve. The Reparel Knee Sleeve is a Class I Medical Device (510(k) exempt) and used in general sports medicine practice for the alleviation of knee pain. The authors expect that the Reparel thermos-active knee sleeve will have a significant effect on pain relief from knee OA.
Interventions
DEVICEReparel Knee Sleeve
Patients who are recommended for non-operative management of knee osteoarthritis and have been consented in clinic to participate in the study will be given a Reparel™ knee sleeve to wear for knee osteoarthritis management. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Reparel™ knee sleeve, patients will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows: wear the sleeve as much as they possibly can; not change their usual activities and diet during the time they are on this study; record in a diary the number of hours sleeve was worn per day; record any adverse effects or discomfort due to sleeve use; refrain from altering treatment for knee osteoarthritis.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* osteoarthritis visible on knee radiograph * patient opting for non-surgical treatment * no corticosteroid knee injection for 90 days prior to consent * no corticosteroid knee injection for 90 days following consent
Exclusion criteria
* bilateral symptomatic knee osteoarthritis * prior surgery on the knee of interest * hardware present on the knee of interest * gross instability detected on physical exam * malignancy in the knee of question
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | 3 months | This is a questionnaire that is self-reported by the patient. It measures knee pain and function. It is scored from 0 to 48. A score of 0 represents the lowest score and is associated with higher knee pain and lower function. A score of 48 represents lower knee pain and higher function. |
| University of California, Los Angeles (UCLA) Activity Score | 3 months | This is a questionnaire that measures current activity level. Patients self report their current activity level. It ranges from 1-10. A patient scoring themselves as a 1 is the lowest current activity level and represents someone who is wholly inactive. A patient scoring themselves as a 10 is the highest current activity level and represents someone able to regularly participate in impact sports. |
| Lysholm Score | 3 months | This is a questionnaire that is self-reported by the patient. It is meant to measure a patient's ability to manage activities of daily living as it relates to their knee. The score range is from 0 to 100. A score of 0 is the lowest score associated with lower ability to manage activities of daily living, and a score of 100 is the highest score associated with a higher ability to manage activities of daily living. |
| Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P) | 3 months | This is a patient questionnaire that is self-reported. It is a measure of how much pain a patient has during different activities. A score of 100 represents the lowest level of pain with different activities. A score of 0 represents the highest amount of pain with different activities. |
| Single Assessment Numeric Evaluation (SANE) | 3 months | This is a patient questionnaire that is self-reported by the patient. It represents a patient's perceived functional level of their affected joint as a percentage of normal. The score is ranged from 0% to 100%. A score of 100% is the best outcome with the patient perceiving their functional level as 100% of normal. |
| Visual Analog Scale (VAS) | 3 months | This is a patient questionnaire that is self-reported by the patient. It measures how much knee pain the patient is having. The score ranges from 0 to 10. A score of 0 represents the best outcome with the least amount of pain. A score of 10 is the worst outcome with the most amount of pain. |
| Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy) | 3 months | This is a patient questionnaire that is self-reported. It represents the amount of knee symptoms a patient has. A score of 0 represents the worst outcome with a patient reporting the most symptoms. A score of 100 represents the best outcome with patients reporting the least symptoms. |
| Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL) | 3 months | This is a patient questionnaire that is self-reported by the patient. It measures the ability of a patient to perform activities of daily living as it relates to a patient's knee. A score of 0 represents the worst outcome with patients reporting the most difficulty performing activities of daily living. A score of 100 represents the best outcome with patients reporting the least difficulty with performing activities of daily living. |
| Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) | 3 months | This is a patient questionnaire that is self-reported by the patient. It measures a patient's quality of life as it relates to their knee. A score of 0 represents the lowest quality of life as it relates to a patient's knee. A score of 100 represents the highest quality of life as it relates to a patient's knee. |
| Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp) | 3 months | This is a patient questionnaire that is self-reported by the patient. It measures a patient's ability to perform sports and recreation as it relates to their knee. A score of 0 represents the lowest ability to perform sports and recreation as it relates to their knee. A score of 100 represents the highest ability to perform sports and recreation as it relates to their knee. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reparel Sleeve Group Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.
Reparel Knee Sleeve: Patients who are recommended for non-operative management of knee osteoarthritis and have been consented in clinic to participate in the study will be given a Reparel™ knee sleeve to wear for knee osteoarthritis management. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Reparel™ knee sleeve, patients will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows: wear the sleeve as much as they possibly can; not change their usual activities and diet during the time they are on this study; record in a diary the number of hours sleeve was worn per day; record any adverse effects or discomfort due to sleeve use; refrain from altering treatment for knee osteoarthritis. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Reparel Sleeve Group | — |
|---|---|---|
| Age, Continuous Female | 60.5 years STANDARD_DEVIATION 12.8 | — |
| Age, Continuous Male | 66.0 years STANDARD_DEVIATION 11.9 | — |
| Body Mass Index Female | 34.3 kilograms per meter squared STANDARD_DEVIATION 6.6 | — |
| Body Mass Index Male | 33.7 kilograms per meter squared STANDARD_DEVIATION 2.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 6 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)
This is a patient questionnaire that is self-reported by the patient. It measures the ability of a patient to perform activities of daily living as it relates to a patient's knee. A score of 0 represents the worst outcome with patients reporting the most difficulty performing activities of daily living. A score of 100 represents the best outcome with patients reporting the least difficulty with performing activities of daily living.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 patients filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL) | 81.37 score on a scale | Standard Deviation 16 |
Primary
Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)
This is a patient questionnaire that is self-reported. It is a measure of how much pain a patient has during different activities. A score of 100 represents the lowest level of pain with different activities. A score of 0 represents the highest amount of pain with different activities.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P) | 72.9 score on a scale | Standard Deviation 15.2 |
Primary
Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)
This is a patient questionnaire that is self-reported by the patient. It measures a patient's quality of life as it relates to their knee. A score of 0 represents the lowest quality of life as it relates to a patient's knee. A score of 100 represents the highest quality of life as it relates to a patient's knee.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) | 59.9 score on a scale | Standard Deviation 21.6 |
Primary
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp)
This is a patient questionnaire that is self-reported by the patient. It measures a patient's ability to perform sports and recreation as it relates to their knee. A score of 0 represents the lowest ability to perform sports and recreation as it relates to their knee. A score of 100 represents the highest ability to perform sports and recreation as it relates to their knee.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp) | 47.5 score on a scale | Standard Deviation 21.3 |
Primary
Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy)
This is a patient questionnaire that is self-reported. It represents the amount of knee symptoms a patient has. A score of 0 represents the worst outcome with a patient reporting the most symptoms. A score of 100 represents the best outcome with patients reporting the least symptoms.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy) | 75.6 score on a scale | Standard Deviation 16.1 |
Primary
Lysholm Score
This is a questionnaire that is self-reported by the patient. It is meant to measure a patient's ability to manage activities of daily living as it relates to their knee. The score range is from 0 to 100. A score of 0 is the lowest score associated with lower ability to manage activities of daily living, and a score of 100 is the highest score associated with a higher ability to manage activities of daily living.
Time frame: 3 months
Population: Although 14 patients were enrolled at baseline, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Lysholm Score | 75.0 score on a scale | Standard Deviation 15.3 |
Primary
Oxford Knee Score (OKS)
This is a questionnaire that is self-reported by the patient. It measures knee pain and function. It is scored from 0 to 48. A score of 0 represents the lowest score and is associated with higher knee pain and lower function. A score of 48 represents lower knee pain and higher function.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Oxford Knee Score (OKS) | 38.2 score on a scale | Standard Deviation 7 |
Primary
Single Assessment Numeric Evaluation (SANE)
This is a patient questionnaire that is self-reported by the patient. It represents a patient's perceived functional level of their affected joint as a percentage of normal. The score is ranged from 0% to 100%. A score of 100% is the best outcome with the patient perceiving their functional level as 100% of normal.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Single Assessment Numeric Evaluation (SANE) | 72.0 percentage score | Standard Deviation 31 |
Primary
University of California, Los Angeles (UCLA) Activity Score
This is a questionnaire that measures current activity level. Patients self report their current activity level. It ranges from 1-10. A patient scoring themselves as a 1 is the lowest current activity level and represents someone who is wholly inactive. A patient scoring themselves as a 10 is the highest current activity level and represents someone able to regularly participate in impact sports.
Time frame: 3 months
Population: Although 14 patients were enrolled at baseline, only 12 patients filled out their surveys at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | University of California, Los Angeles (UCLA) Activity Score | 5.4 score on a scale | Standard Deviation 1.4 |
Primary
Visual Analog Scale (VAS)
This is a patient questionnaire that is self-reported by the patient. It measures how much knee pain the patient is having. The score ranges from 0 to 10. A score of 0 represents the best outcome with the least amount of pain. A score of 10 is the worst outcome with the most amount of pain.
Time frame: 3 months
Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reparel Sleeve Group | Visual Analog Scale (VAS) | 3.0 score on a scale | Standard Deviation 2.9 |