NCT04859764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

March 2, 2021

Last Update Submit

January 18, 2026

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (19)

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

    activity score, 1-10, 10 is best outcome

    4 weeks (T1)

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

    activity score, 1-10, 10 is best outcome

    3 months (T2)

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

    activity score, 1-10, 10 is best outcome

    6 months (T3)

  • Change in Lysholm Score at 4 weeks

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

    4 weeks (T1)

  • Change in Lysholm Score at 3 months

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

    3 months (T2)

  • Change in Lysholm Score at 6 months

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

    6 months (T3)

  • Change in Oxford Knee Score (OKS) at 4 weeks

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

    4 weeks (T1)

  • Change in Oxford Knee Score (OKS) at 3 months

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

    3 months (T2)

  • Change in Oxford Knee Score (OKS) at 6 months

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

    6 months (T3)

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

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

    4 weeks (T1)

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

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

    3 months (T2)

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

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

    6 months (T3)

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

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

    4 weeks (T1)

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

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

    3 months (T2)

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

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

    6 months (T3)

  • Need for Additional CSI

    need for additional CSI after baseline injection

    6 months

  • Change in Visual Analog Scale (VAS) at 4 weeks

    pain score, 0-10, 10 is best outcome

    4 weeks (T1)

  • Change in Visual Analog Scale (VAS) at 3 months

    pain score, 0-10, 10 is best outcome

    3 months (T2)

  • Change in Visual Analog Scale (VAS) at 6 months

    pain score, 0-10, 10 is best outcome

    6 months (T3)

Secondary Outcomes (6)

  • Satisfaction with knee sleeve at 4 weeks

    4 weeks (T1)

  • Satisfaction with knee sleeve at 3 months

    3 months (T2)

  • Satisfaction with knee sleeve at 6 months

    6 months (T3)

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

    4 weeks (T1)

  • Average wear time of sleeve over past week at 3 months

    3 months (T2)

  • +1 more secondary outcomes

Study Arms (2)

Reparel Sleeve Group

EXPERIMENTAL

Reparel sleeve and corticosteroid injection

Device: Reparel knee sleeveDrug: Corticosteroid injection

Placebo Sleeve Group

PLACEBO COMPARATOR

Placebo sleeve and corticosteroid injection

Drug: Corticosteroid injectionDevice: Placebo knee sleeve

Interventions

Placebo knee sleeveDEVICE

unlabeled compression knee sleeve

Placebo Sleeve Group
Reparel knee sleeveDEVICE

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

Reparel Sleeve Group
Corticosteroid injectionDRUG

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

Also known as: betamethasone and bupivacaine 0.5%
Placebo Sleeve GroupReparel Sleeve Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex HormonesBetamethasone

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Amit Momaya, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Section Chief, Sports Medicine

Study Record Dates

First Submitted

March 2, 2021

First Posted

April 26, 2021

Study Start

June 29, 2022

Primary Completion

December 1, 2025

Study Completion

December 3, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)