Reparel Knee Sleeve + Injection for Osteoarthritis

Overseen By Amit Momaya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Bilateral knee OA, prior knee surgery, others

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new knee sleeve, made by Reparel™, in managing knee osteoarthritis (OA) compared to a placebo sleeve. The trial combines this sleeve with a common treatment, a corticosteroid injection, to assess improvements in mobility, function, and pain. Individuals with knee OA confirmed by an X-ray who seek non-surgical options might be suitable candidates. As an unphased trial, this study provides patients the chance to explore innovative non-surgical treatments for knee OA.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Reparel knee sleeve is safe for treating knee osteoarthritis?

A previous study showed that the Reparel knee sleeve helped people with knee osteoarthritis (OA) feel less pain and improve movement. No major safety issues were reported, but further research is needed.

For corticosteroid injections, studies have shown they can reduce OA symptoms for about 12 weeks. However, some research suggests they might weaken cartilage over time, potentially causing more damage. It's important to weigh both the benefits and possible risks when considering this option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for osteoarthritis, like pain relievers and physical therapy, mainly focus on managing symptoms. But the combination of a corticosteroid injection and the Reparel knee sleeve offers something different. The Reparel sleeve provides targeted compression and improved blood flow, potentially enhancing the effects of the corticosteroid. Researchers are excited because this dual approach could offer more effective, longer-lasting relief for knee osteoarthritis than current options. Plus, the Reparel sleeve's non-invasive nature makes it a promising addition to traditional therapies.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research shows that corticosteroid injections, one of the treatments in this trial, can reduce pain and improve symptoms in people with knee osteoarthritis. Several studies have found that triamcinolone injections provide significant pain relief and improve joint function. These injections can also enhance quality of life for several weeks after treatment. Studies suggest that the Reparel knee sleeve, another treatment option in this trial, may help with pain, symptoms, and mobility in knee osteoarthritis, though more research is needed to confirm these early results. This trial studies both treatments for their potential to improve movement and reduce discomfort in knee osteoarthritis. ^{6 7 8 9 10}

Who Is on the Research Team?

Amit Momaya, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis visible on X-rays who are choosing non-surgical treatments. It's not suitable for those with cancer in the affected knee, significant instability upon examination, symptoms in both knees, any hardware installed or previous surgery on the target knee.

Inclusion Criteria

osteoarthritis visible on knee radiograph

I am choosing a treatment that does not involve surgery.

Exclusion Criteria

I have pain in both knees due to arthritis.

I have had surgery on the knee we are discussing.

You have a metal device implanted in the knee being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Reparel knee sleeve or a placebo knee sleeve, along with corticosteroid injection. They are instructed to wear the sleeve as much as possible and maintain a diary of usage and any adverse effects.

6 months

Baseline randomization visit, follow-up visits at 4 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments using various scores such as KOOS, SANE, OKS, Lysholm, UCLA Activity Score, and VAS.

6 months

Follow-up assessments at 4 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid injection
• Placebo knee sleeve
• Reparel knee sleeve

Trial Overview

The study aims to see if wearing a Reparel™ knee sleeve can improve mobility, function, and pain better than a placebo sleeve when managing knee OA. Participants will also receive corticosteroid injections as part of their treatment.

How Is the Trial Designed?

Group I: Reparel Sleeve Group Experimental Treatment 2 Interventions

Reparel sleeve and corticosteroid injection

Group II: Placebo Sleeve Group Placebo Group 2 Interventions

Placebo sleeve and corticosteroid injection

Corticosteroid injection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Approved in European Union as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Approved in Canada as Corticosteroids for:

• Allergic reactions
• Asthma
• COPD
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendonitis
• Skin conditions
• Eye conditions
• Gastrointestinal disorders

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Corticosteroid injections for knee disorders like osteoarthritis and rheumatoid arthritis have been used since the 1950s and are effective for rapid symptom relief while minimizing systemic side effects.

The technique for administering intra-articular knee injections is straightforward and can be performed quickly in both office and hospital settings, making it accessible for treating acute or severe symptom flares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable corticosteroids in treatment of arthritis of the knee. Schumacher, HR., Chen, LX.[2022]

In a study of 210 patients with trigger finger, the type of steroid used for injections significantly influenced clinical outcomes, with triamcinolone leading to a higher rate of additional injections compared to dexamethasone and methylprednisolone.

Patients receiving methylprednisolone not only required surgical intervention more frequently but also underwent surgery earlier than those treated with the other steroids, suggesting that the choice of corticosteroid is crucial in managing trigger finger.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of Corticosteroid Solution and Outcome After Injection for Trigger Finger. Roberts, JM., Behar, BJ., Siddique, LM., et al.[2022]

Injectable corticosteroids can cause side effects like lipoatrophy, especially when misused by non-dermatologists, highlighting the need for careful administration.

Serial saline injections have been found to be a safe, quick, and cost-effective treatment for steroid-induced lipoatrophy in children, providing a practical alternative to manage this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. Daruwalla, SB., Dhurat, RS., Sharma, A., et al.[2021]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

A 12-year-old girl developed a rare atrophic linear plaque on her arm after receiving an intra-articular triamcinolone injection for juvenile inflammatory arthritis, highlighting a potential complication of steroid injections.

The plaque resolved on its own over about a year, emphasizing the importance of recognizing this condition to prevent misdiagnosis as linear scleroderma, which could lead to unnecessary immunosuppressive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear lipoatrophy following intra-articular triamcinolone acetonide injection mimicking linear scleroderma. Call, JE., Mann, JA., Linos, KD., et al.[2019]

In a study of 60 children under 10 with pauci-articular juvenile chronic arthritis, 77% of treated knees showed excellent or good outcomes one year after receiving local injections of triamcinolone hexacetonide.

The treatment was effective in controlling disease activity, with only minor complications reported, such as small areas of subcutaneous tissue atrophy in 2 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. Earley, A., Cuttica, RJ., McCullough, C., et al.[2017]

In a study involving 60 patients undergoing bilateral total knee arthroplasty, the use of a multimodal cocktail injection with corticosteroids did not show significant differences in pain relief, motion range, or swelling compared to injections without corticosteroids.

The findings suggest that multimodal periarticular injections without corticosteroids can effectively manage postoperative pain and swelling, indicating that corticosteroids like betamethasone may not be necessary for optimal outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. Peng, H., Wang, W., Lin, J., et al.[2021]

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

A case report highlights significant complications from locoregional corticosteroid injection, including pigmentation changes, muscle wasting, and tendon rupture in a 17-year-old woman after receiving triamcinolone in her wrist.

The incident underscores the importance of proper training for healthcare providers performing corticosteroid injections, especially in resource-limited settings, to prevent iatrogenic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pigmentation change, muscle wasting, and tendon rupture after corticosteroid injection in the Congo]. Bileckot, RR., Mavoungou Biatsi, K., Loumingou, LI.[2013]

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

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