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Not yet recruiting NCT05714397

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

No phase Interventional Anterior Knee Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cingal.
Who it may be relevant to
Registry conditions: Anterior Knee Pain Syndrome. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Cingal
    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.

Primary outcome measures

  • 2D Kinematic Data [Time frame: baseline, 6 weeks, 12 weeks]
Secondary outcome measures (6)
  • Strength Testing [Time frame: baseline, 12 weeks]
  • Biomechanical Assessment [Time frame: baseline, 12 weeks]
  • Pain scores measured using a 100 mm Visual Analog Scale (VAS) [Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks]
  • Anterior knee pain using the Anterior Knee Pain Scale (AKPS) [Time frame: 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) [Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks]
  • General activity rating using the Marx Activity Score [Time frame: baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Banff Sport Medicine — Canmore

Identifiers

NCT: NCT05714397 · REB21-0205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗