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

NCT05714397 | Not Yet Recruiting

• 1 other identifier: REB21-0205
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Knee Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 2D Kinematic Data

  Kinematic data will be collected at baseline and 6 and 12 weeks after administration of the Cingal™ injection. Outcome measures include ankle dorsiflexion at contact, maximum rear foot eversion, knee flexion at contact, knee adduction in late stance, and hip joint angle. In addition, the mean of three angle measurements for each parameter will be recorded.

  baseline, 6 weeks, 12 weeks

Secondary Outcomes (6)

• Strength Testing

  baseline, 12 weeks

• Biomechanical Assessment

  baseline, 12 weeks

• Pain scores measured using a 100 mm Visual Analog Scale (VAS)

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

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

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

• Symptoms of knee injury using the Knee Injury and Osteoarthritis Outcomes Score (KOOS)

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

Study Arms (1)

Cingal Injection

EXPERIMENTAL

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.

Device: Cingal

Interventions

Cingal DEVICE

A single Cingal injection 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.

Cingal Injection

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Banff Sport Medicine Foundation: lead

Study Sites (1)

Banff Sport Medicine

Canmore, Alberta, T1W 0L5, Canada

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Laurie Hiemstra, MD PhD FRCSC

  Banff Sport Medicine Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie-Anne Fritz, PhD

CONTACT

4037602897; BSMresearch@banffsportmed.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 6, 2023
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)