About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Cingal
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Strength Testing
A crane scale (strain gauge) will assess isometric strength testing of the quadriceps and hamstring muscles.
Biomechanical Assessment
The Drop Vertical Jump test will be used to assess dynamic valgus collapse of the knee.
Pain scores measured using a 100 mm Visual Analog Scale (VAS)
The Pain VAS is anchored by 0, which corresponds to "no pain", and 10, which corresponds to the "worst possible pain".
Anterior knee pain using the Anterior Knee Pain Scale (AKPS)
The AKPS is a 13-item knee-specific self-report questionnaire. It documents responses to six activities thought to be explicitly associated with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. In addition, the AKPS asks about the duration of symptoms and the limb(s) affected. The maximum score is 100, and lower scores indicate greater pain/disability.
Sponsors and contacts
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