Your session is about to expire
← Back to Search
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
Study Summary
This trial tested Cingal™ to treat AKP. It showed that Cingal™ can reduce knee pain and improve joint function, providing short-term relief to those suffering from AKP.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2D Kinematic Data
Secondary outcome measures
Anterior knee pain using the Anterior Knee Pain Scale (AKPS)
Biomechanical Assessment
General activity rating using the Marx Activity Score
+3 moreSide effects data
From 2018 Phase 3 trial • 576 Patients • NCT0319190312%
Headache
5%
Viral upper respiratory tract infection
3%
Injection site pain
2%
Spinal pain
2%
Upper respiratory tract infection
2%
Toothache
1%
Pyrexia
1%
Hypoaesthesia
1%
Abdominal Pain Upper
1%
Bronchitis
1%
Influenza
1%
Laryngitis
1%
Ear Pain
1%
Diarrhea
1%
Injection site reaction
1%
Back pain
1%
Pain in extremity
1%
Migraine
1%
Joint swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cingal
Monovisc
Triamcinolone Hexacetonide (TH)
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
Find a Location
Who is running the clinical trial?
Banff Sport Medicine FoundationLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
Laurie Hiemstra, MD PhD FRCSCPrincipal InvestigatorBanff Sport Medicine Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to Cingal™ or its ingredients.I have no health issues that prevent knee injections.My knee X-ray shows signs of arthritis or a fracture.I might have a knee injury involving the meniscus or ligaments.I have had knee surgery before.I am between 18 and 35 years old.I have had specific knee x-rays taken while standing.I have had knee pain around my kneecap for at least 2 months.I have not had a knee injection in the last 3 months.My AKP hasn't improved after 6 weeks of non-surgical treatments.I have diabetes, an inflammatory condition, or a condition that affects how I feel pain.My knee pain worsens with activities like squatting, running, or climbing stairs.
Research Study Groups:
This trial has the following groups:- Group 1: Cingal Injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals above the age of 30 acceptable participants in this research?
"This research is seeking persons aged between 18-35 years to partake."
Answered by AI
Is there an ongoing recruitment process for this clinical experiment?
"Contrary to what one may expect, this research study is not presently seeking out participants. Despite having been initially posted on April 1st 2023 and last updated on January 26th 2023, it appears that no more candidates are required at the moment. Fortunately, there are 21 other trials currently recruiting patients as we speak."
Answered by AI
Who would be the ideal candidates for enrollment in this trial?
"The medical trial is seeking 24 young adults with patellofemoral pain syndrome between 18 and 35 years old. The following prerequisites need to be met: age, a standard weight-bearing AP/Skyline view knee x-ray, at least two months of retropatellar or peripatellar discomfort that has not been relieved by conservative therapies (modifications in activity, supervised physiotherapy, exercise therapy, taping/bracing or NSAIDS), and worsened symptoms when performing certain activities such as squatting, running up/down stairs or sitting for extended periods of time with the knees bent."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger