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Completed

NCT Number: NCT04859764

Effect of Reparel Knee Sleeve With Knee Injection

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

About this study

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

  • Reparel knee sleeve
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reparel Knee Sleeve

Device

Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain

Corticosteroid injection

Drug

intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)

Other names: betamethasone and bupivacaine 0.5%

Placebo knee sleeve

Device

unlabeled compression knee sleeve

Primary outcomes

  1. Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks

    Time frame: 4 weeks (T1)

    activity score, 1-10, 10 is best outcome

  2. Change in University of California, Los Angeles (UCLA) Activity Score at 3 months

    Time frame: 3 months (T2)

    activity score, 1-10, 10 is best outcome

  3. Change in University of California, Los Angeles (UCLA) Activity Score at 6 months

    Time frame: 6 months (T3)

    activity score, 1-10, 10 is best outcome

  4. Change in Lysholm Score at 4 weeks

    Time frame: 4 weeks (T1)

    ability to manage activities of daily living, 0-100, 100 is best outcome

  5. Change in Lysholm Score at 3 months

    Time frame: 3 months (T2)

    ability to manage activities of daily living, 0-100, 100 is best outcome

  6. Change in Lysholm Score at 6 months

    Time frame: 6 months (T3)

    ability to manage activities of daily living, 0-100, 100 is best outcome

  7. Change in Oxford Knee Score (OKS) at 4 weeks

    Time frame: 4 weeks (T1)

    knee pain and function score, 0-48, 48 is best outcome

  8. Change in Oxford Knee Score (OKS) at 3 months

    Time frame: 3 months (T2)

    knee pain and function score, 0-48, 48 is best outcome

  9. Change in Oxford Knee Score (OKS) at 6 months

    Time frame: 6 months (T3)

    knee pain and function score, 0-48, 48 is best outcome

  10. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks

    Time frame: 4 weeks (T1)

    knee pain and function score, 0-100, 100 is best outcome

  11. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months

    Time frame: 3 months (T2)

    knee pain and function score, 0-100, 100 is best outcome

  12. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months

    Time frame: 6 months (T3)

    knee pain and function score, 0-100, 100 is best outcome

  13. Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks

    Time frame: 4 weeks (T1)

    function score, 0-100%, 100% is best outcome

  14. Change in Single Assessment Numeric Evaluation (SANE) at 3 months

    Time frame: 3 months (T2)

    function score, 0-100%, 100% is best outcome

  15. Change in Single Assessment Numeric Evaluation (SANE) at 6 months

    Time frame: 6 months (T3)

    function score, 0-100%, 100% is best outcome

  16. Need for Additional CSI

    Time frame: 6 months

    need for additional CSI after baseline injection

  17. Change in Visual Analog Scale (VAS) at 4 weeks

    Time frame: 4 weeks (T1)

    pain score, 0-10, 10 is best outcome

  18. Change in Visual Analog Scale (VAS) at 3 months

    Time frame: 3 months (T2)

    pain score, 0-10, 10 is best outcome

  19. Change in Visual Analog Scale (VAS) at 6 months

    Time frame: 6 months (T3)

    pain score, 0-10, 10 is best outcome

Secondary outcomes

  1. Satisfaction with knee sleeve at 4 weeks

    Time frame: 4 weeks (T1)

    0-10, 10 is best

  2. Satisfaction with knee sleeve at 3 months

    Time frame: 3 months (T2)

    0-10, 10 is best

  3. Satisfaction with knee sleeve at 6 months

    Time frame: 6 months (T3)

    0-10, 10 is best

  4. Average wear time of sleeve over past week at 4 weeks

    Time frame: 4 weeks (T1)

    0-24 hours, 24 hours is best

  5. Average wear time of sleeve over past week at 3 months

    Time frame: 3 months (T2)

    0-24 hours, 24 hours is best

  6. Average wear time of sleeve over past week at 6 months

    Time frame: 6 months (T3)

    0-24 hours, 24 hours is best

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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