Reparel Knee Sleeve + Injection for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Amit Momaya, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Bilateral knee OA, prior knee surgery, others

Trial Summary

What is the purpose of this trial?

This trial is testing a special knee brace called the Reparel™ knee sleeve to see if it helps people with knee osteoarthritis move better and feel less pain. The sleeve is thought to work by reducing swelling and supporting the knee. Patients who can't have surgery are trying this new sleeve to see if it works better than a regular one.

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 data supports the effectiveness of the treatment Reparel Knee Sleeve + Injection for Osteoarthritis?

Research shows that triamcinolone acetonide extended-release injections significantly improve pain, stiffness, and physical function in knee osteoarthritis compared to placebo, with effects lasting up to 24 weeks. This suggests that corticosteroid injections, a component of the treatment, can be effective in managing osteoarthritis symptoms. ^{1 2 3 4 5}

Is the Reparel Knee Sleeve + Injection treatment safe for humans?

Triamcinolone acetonide extended-release, used for knee osteoarthritis, is generally well tolerated with a safety profile similar to placebo. However, local corticosteroid injections can sometimes cause side effects like skin color changes, muscle wasting, and tendon issues, especially if not administered properly. ^{1 3 6 7 8}

How is the Reparel Knee Sleeve + Injection treatment for osteoarthritis different from other treatments?

The Reparel Knee Sleeve + Injection treatment combines a corticosteroid injection, which provides rapid symptom relief by reducing inflammation, with a Reparel knee sleeve that may offer additional support and comfort. This combination aims to enhance the overall effectiveness and comfort compared to using corticosteroid injections alone. ^{1 2 3 9 10}

Research Team

Amit Momaya, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Corticosteroid injection (Corticosteroid)
• Placebo knee sleeve (Behavioural Intervention)
• Reparel knee sleeve (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Triamcinolone into the knee joint in juvenile chronic arthritis. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Choice of Corticosteroid Solution and Outcome After Injection for Trigger Finger. [2022]

6. United States 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. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Pigmentation change, muscle wasting, and tendon rupture after corticosteroid injection in the Congo]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Injectable corticosteroids in treatment of arthritis of the knee. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Linear lipoatrophy following intra-articular triamcinolone acetonide injection mimicking linear scleroderma. [2019]