What side effects are associated with this type of intervention?

Treatments for Patellofemoral Pain Syndrome similar to Cingal™, which includes Hyaluronic Acid (HA) and Triamcinolone Hexacetonide (TH), have known side effects. HA can cause local reactions such as pain, swelling, and redness at the injection site. TH, a corticosteroid, may lead to joint infection, post-injection flare, and systemic effects like elevated blood sugar levels. Repeated corticosteroid use can also result in joint damage and soft tissue atrophy.

What prior FDA approvals exist?

The FDA has approved various treatments for knee pain and inflammation, including the use of Hyaluronic Acid (HA) and corticosteroids like Triamcinolone Hexacetonide (TH). HA is commonly used as a joint lubricant to improve knee function and reduce pain in conditions such as osteoarthritis. Triamcinolone Hexacetonide, a potent corticosteroid, is used for its anti-inflammatory properties to provide pain relief. Cingal™, which combines HA and TH, has shown effectiveness in improving joint function and providing short-term pain relief for conditions like Patellofemoral Pain Syndrome.

What other types of research exist?

Promising novel alternatives to Cingal™ for Patellofemoral Pain Syndrome patients include: 1) Loteprednol etabonate, a new soft steroid that effectively blocks inflammatory responses in joint conditions. 2) Lornoxicam, which has shown good local tolerability and effectiveness in joint inflammation management. These alternatives may offer new avenues for treatment in 2024.

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Viscosupplement

Cingal™ for Patellofemoral Pain Syndrome

N/A

Waitlist Available

Led By Laurie Hiemstra, MD PhD FRCSC

Research Sponsored by Banff Sport Medicine Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates Cingal™, a treatment for patients with Anterior Knee Pain (AKP). Cingal™ combines a lubricant for the knee joint and an anti-inflammatory to reduce pain and swelling, aiming to improve knee function. A recent trial demonstrated that patients treated with Cingal experienced greater pain reductions compared to other treatments.

Who is the study for?

This trial is for people aged 18-35 with Anterior Knee Pain (AKP) lasting over 2 months, who haven't improved after at least 6 weeks of non-surgical treatments. They must have pain during activities like squatting or stair climbing and can't be overweight, pregnant, or have had previous knee surgery among other exclusions.

What is being tested?

The trial tests Cingal™, which combines hyaluronic acid for joint lubrication and a steroid called triamcinolone hexacetonide to relieve pain. It aims to see if this treatment improves knee function and reduces pain in those with AKP.

What are the potential side effects?

Possible side effects of Cingal™ may include reactions at the injection site such as pain or swelling, allergic reactions to its ingredients, increased risk of infection due to the steroid component, and potential impact on blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2D Kinematic Data

Secondary study objectives

Anterior knee pain using the Anterior Knee Pain Scale (AKPS)

Biomechanical Assessment

General activity rating using the Marx Activity Score

+3 more

Side effects data

From 2018 Phase 3 trial • 576 Patients • NCT03191903

11%

Headache

Viral upper respiratory tract infection

Injection site pain

Influenza

Pain in extremity

Spinal pain

Back pain

Diarrhea

Abdominal Pain Upper

Bronchitis

Upper respiratory tract infection

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Monovisc

Triamcinolone Hexacetonide (TH)

Cingal

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cingal InjectionExperimental Treatment1 Intervention

Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cingal

2020

Completed Phase 3

~1750

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Patellofemoral Pain Syndrome (PFPS) is commonly treated with a combination of hyaluronic acid (HA) and corticosteroids like triamcinolone hexacetonide. HA acts as a joint lubricant, improving the viscosity of the synovial fluid, which helps to reduce friction and wear in the knee joint. This can enhance joint function and provide pain relief. Triamcinolone hexacetonide is a potent anti-inflammatory agent that reduces inflammation and swelling in the knee, thereby alleviating pain and improving mobility. These mechanisms are crucial for PFPS patients as they directly address the pain and functional limitations caused by the condition, leading to improved quality of life and potentially delaying the need for more invasive treatments.

Intra-articular triamcinolone hexacetonide and osmic acid in persistent synovitis of the knee.The effect of a corticosteroid on the absorption of 131I-albumin from rabbit knee joint.Effect of intravenous tiludronate disodium administration on the radiographic progression of osteoarthritis of the fetlock joint in Standardbred racehorses.