Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain

Banff Sport Medicine Foundation

Status: Begins enrollment in 1 month

Conditions: Anterior Knee Pain Syndrome

Treatments: Device: Cingal

Study type: Interventional

Funder types: Other

Identifiers

NCT05714397

REB21-0205

Details and patient eligibility

About

Anterior Knee Pain (AKP) is a common condition that can be challenging to treat effectively. The main goal of treatment regimens is to improve the function of the knee. However, treatment can be challenging due to the knee pain experience. Cingal™ contains hyaluronic acid (HA), which acts as a joint lubricant, and the corticosteroid triamcinolone hexacetonide (TH). Some studies have shown that Cingal™ can improve joint function and provide short-term pain relief.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 35 years
• Standard weight-bearing AP and skyline view knee x-rays
• Retropatellar or peripatellar knee pain for a minimum of 2 months
• Confirmed diagnosis of AKP that has failed to improve with a minimum of 6 weeks of conservative treatment (activity modification, supervised physiotherapy, exercise therapy, taping or bracing, NSAIDS)
• Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion.

Exclusion criteria

• X-ray evidence of knee osteoarthritis or fracture
• Meniscal or ligamentous injury assessed or suspected on clinical examination
• Previous knee surgery
• History of patellar instability
• Any contraindication to knee injection (overlying skin condition, joint infection, significant joint effusion, coagulopathy, previous adverse reaction, etc.)
• Known allergy to Cingal™ or its constituents
• Previous knee injection within the last 3 months
• BMI greater than 30 kg/m2
• Diabetes, inflammatory conditions (rheumatologic disease, ankylosing spondylitis), or concurrent medical conditions which may result in chronic pain or altered pain sensation
• Pregnant or breastfeeding
• Workers Compensation Board case
• Patient involved in litigation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Cingal Injection

Experimental group

Description:

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:

Device: Cingal