Trial Outcomes & Findings for Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis (NCT NCT04743921)

NCT ID: NCT04743921

Last Updated: 2024-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-05-16

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Average age and standard deviation was calculated for males and females separately

Baseline characteristics by cohort

Measure	Reparel Sleeve Group n=14 Participants 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.
Age, Continuous Female	60.5 years STANDARD_DEVIATION 12.8 • n=10 Participants • Average age and standard deviation was calculated for males and females separately
Age, Continuous Male	66.0 years STANDARD_DEVIATION 11.9 • n=4 Participants • Average age and standard deviation was calculated for males and females separately
Sex: Female, Male Female	10 Participants n=14 Participants
Sex: Female, Male Male	4 Participants n=14 Participants
Body Mass Index Male	33.7 kilograms per meter squared STANDARD_DEVIATION 2.6 • n=4 Participants • There were a total of 14 participants: 4 males and 10 females.
Body Mass Index Female	34.3 kilograms per meter squared STANDARD_DEVIATION 6.6 • n=10 Participants • There were a total of 14 participants: 4 males and 10 females.

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled at baseline, only 12 patients filled out their surveys at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

University of California, Los Angeles (UCLA) Activity Score

5.4 score on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled at baseline, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Lysholm Score

75.0 score on a scale Standard Deviation 15.3

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Oxford Knee Score (OKS)

38.2 score on a scale Standard Deviation 7.0

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)

72.9 score on a scale Standard Deviation 15.2

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Single Assessment Numeric Evaluation (SANE)

72.0 percentage score Standard Deviation 31.0

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Visual Analog Scale (VAS)

3.0 score on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy)

75.6 score on a scale Standard Deviation 16.1

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 patients filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)

81.37 score on a scale Standard Deviation 16.0

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)

59.9 score on a scale Standard Deviation 21.6

PRIMARY outcome

Timeframe: 3 months

Population: Although 14 patients were enrolled, only 12 filled out their questionnaires at 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.

Outcome measures

Measure

Reparel Sleeve Group n=12 Participants 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.

Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp)

47.5 score on a scale Standard Deviation 21.3

Adverse Events

Reparel Sleeve Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Reparel Sleeve Group n=14 participants at risk 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.
Skin and subcutaneous tissue disorders Knee swelling	21.4% 3/14 • 3 months
Skin and subcutaneous tissue disorders Skin Irritation	14.3% 2/14 • 3 months
Skin and subcutaneous tissue disorders Lower leg and foot swelling	7.1% 1/14 • 3 months

Additional Information

Dr. Amit Momaya

University of Alabama at Birmingham Department of Orthopaedic Surgery

Phone: 205-975-2663

Email: amomaya@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place