Effect of Reparel Knee Sleeve With Knee Injection

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04859764
Collaborator
(none)
74
1
2
11.1
6.7

Study Details

Study Description

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 Reparelâ„¢ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee OA.

Condition or Disease Intervention/Treatment Phase
  • Device: Reparel knee sleeve
  • Drug: Corticosteroid injection
  • Device: Placebo knee sleeve
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
Primary Purpose:
Treatment
Official Title:
Effects of Corticosteroid Injection Plus Reparelâ„¢ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reparel Sleeve Group

Reparel sleeve and corticosteroid injection

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

Drug: Corticosteroid injection
intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)
Other Names:
  • betamethasone and bupivacaine 0.5%
  • Placebo Comparator: Placebo Sleeve Group

    Placebo sleeve and corticosteroid injection

    Drug: Corticosteroid injection
    intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)
    Other Names:
  • betamethasone and bupivacaine 0.5%
  • Device: Placebo knee sleeve
    unlabeled compression knee sleeve

    Outcome Measures

    Primary Outcome Measures

    1. Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks [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 [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 [6 months (T3)]

      activity score, 1-10, 10 is best outcome

    4. Change in Lysholm Score at 4 weeks [4 weeks (T1)]

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

    5. Change in Lysholm Score at 3 months [3 months (T2)]

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

    6. Change in Lysholm Score at 6 months [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 [4 weeks (T1)]

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

    8. Change in Oxford Knee Score (OKS) at 3 months [3 months (T2)]

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

    9. Change in Oxford Knee Score (OKS) at 6 months [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 [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 [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 [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 [4 weeks (T1)]

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

    14. Change in Single Assessment Numeric Evaluation (SANE) at 3 months [3 months (T2)]

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

    15. Change in Single Assessment Numeric Evaluation (SANE) at 6 months [6 months (T3)]

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

    16. Change in Visual Analog Scale (VAS) at 4 weeks [4 weeks (T1)]

      pain score, 0-10, 10 is best outcome

    17. Change in Visual Analog Scale (VAS) at 3 months [3 months (T2)]

      pain score, 0-10, 10 is best outcome

    18. Change in Visual Analog Scale (VAS) at 6 months [6 months (T3)]

      pain score, 0-10, 10 is best outcome

    Secondary Outcome Measures

    1. Satisfaction with knee sleeve at 4 weeks [4 weeks (T1)]

      0-10, 10 is best

    2. Satisfaction with knee sleeve at 3 months [3 months (T2)]

      0-10, 10 is best

    3. Satisfaction with knee sleeve at 6 months [6 months (T3)]

      0-10, 10 is best

    4. Average wear time of sleeve over past week at 4 weeks [4 weeks (T1)]

      0-24 hours, 24 hours is best

    5. Average wear time of sleeve over past week at 3 months [3 months (T2)]

      0-24 hours, 24 hours is best

    6. Average wear time of sleeve over past week at 6 months [6 months (T3)]

      0-24 hours, 24 hours is best

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB Hospital Highlands Birmingham Alabama United States 35205

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Amit Momaya, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amit Momaya, Assistant Professor, Section Chief, Sports Medicine, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT04859764
    Other Study ID Numbers:
    • IRB-300006118
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2022