Clinical trial NCT04859764: Effect of Reparel Knee Sleeve with Knee Injection
Official title: Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 if the Reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee OA.

Detailed description: Patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following

1. Reparel knee sleeve
2. Placebo knee sleeve

Participants assigned to both groups 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.
* Not to receive any injections in the subsequent 6 months following baseline randomization visit.

Participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (REDCap).

Participants will also be asked to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Assessment Numeric Evaluation (SANE), Oxford Knee Score (OKS), Lysholm Score, UCLA Activity Score and Visual Analog Scale (VAS) survey questionnaires at baseline randomization visit (T0), at 4 weeks (T1), at 3 months (T2), and at 6 months (T3) to assess the mobility, functionality, and pain associated with the affected leg.

The responses to the surveys will be recorded on a password-protected laptop and all patient identifiers will be replaced with unique identifier numbers. Only the study team will have access to the responses from the forms. The analysis of de-identified data will be done through SPSS 27, and scores for the questionnaires will be averaged and compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis visible on knee radiograph
* patient opting for non-surgical treatment

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

Primary outcomes:
measure: Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
timeFrame: 3 months (T2)
measure: Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
timeFrame: 6 months (T3)
measure: Change in Lysholm Score at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in Lysholm Score at 3 months
timeFrame: 3 months (T2)
measure: Change in Lysholm Score at 6 months
timeFrame: 6 months (T3)
measure: Change in Oxford Knee Score (OKS) at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in Oxford Knee Score (OKS) at 3 months
timeFrame: 3 months (T2)
measure: Change in Oxford Knee Score (OKS) at 6 months
timeFrame: 6 months (T3)
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
timeFrame: 3 months (T2)
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
timeFrame: 6 months (T3)
measure: Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in Single Assessment Numeric Evaluation (SANE) at 3 months
timeFrame: 3 months (T2)
measure: Change in Single Assessment Numeric Evaluation (SANE) at 6 months
timeFrame: 6 months (T3)
measure: Change in Visual Analog Scale (VAS) at 4 weeks
timeFrame: 4 weeks (T1)
measure: Change in Visual Analog Scale (VAS) at 3 months
timeFrame: 3 months (T2)
measure: Change in Visual Analog Scale (VAS) at 6 months
timeFrame: 6 months (T3)
Secondary outcomes:
measure: Satisfaction with knee sleeve at 4 weeks
timeFrame: 4 weeks (T1)
measure: Satisfaction with knee sleeve at 3 months
timeFrame: 3 months (T2)
measure: Satisfaction with knee sleeve at 6 months
timeFrame: 6 months (T3)
measure: Average wear time of sleeve over past week at 4 weeks
timeFrame: 4 weeks (T1)
measure: Average wear time of sleeve over past week at 3 months
timeFrame: 3 months (T2)
measure: Average wear time of sleeve over past week at 6 months
timeFrame: 6 months (T3)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amit Momaya, MD
role: PRINCIPAL_INVESTIGATOR
References: