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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
Age 18 - 35 years
Standard weight-bearing AP and skyline view knee x-rays
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.
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I have had specific knee x-rays taken while standing.
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I have had knee pain around my kneecap for at least 2 months.
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My knee pain worsens with activities like squatting, running, or climbing stairs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 days, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks for reporting.

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 more

Side effects data

From 2018 Phase 3 trial • 576 Patients • NCT03191903
12%
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

Cingal (Viscosupplement) Clinical Trial Eligibility Overview. Trial Name: NCT05714397 — N/A
Patellofemoral Pain Syndrome Research Study Groups: Cingal Injection
Patellofemoral Pain Syndrome Clinical Trial 2023: Cingal Highlights & Side Effects. Trial Name: NCT05714397 — N/A
Cingal (Viscosupplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714397 — N/A

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
~12 spots leftby Apr 2025