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Chondro-Gide® for Knee Cartilage Injury (SECURE Trial)
SECURE Trial Summary
This trial found that treating large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treating small chondral lesions treated with microfracture alone.
SECURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSECURE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SECURE Trial Design
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Who is running the clinical trial?
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- You are allergic to porcine collagen.You have a history of drug or alcohol abuse, as defined by the DSM-V.I have a knee injury identified by MRI or arthroscopy.I am not pregnant and use effective birth control.My knee is currently infected.You have a medical condition that may affect the accuracy of the study results, as determined by the investigator.I have long-term arthritis caused by inflammation or infection.I do not have any health conditions that would affect the study's outcome measurements.I had surgery on my cartilage but not within the last 3 months.I have not used steroids directly in my joints in the last 3 months.I have an abnormal kneecap shape.I am between 18 and 55 years old.I have been diagnosed with osteoporosis through a bone density scan.You have a medical history of autoimmune disease or a weakened immune system.My arthritis is severe, as shown by my X-rays.I am willing and able to follow all study requirements.My symptoms have lasted for more than 3 years.You have a body mass index (BMI) of 30 or higher.My other knee hurts.I am currently on treatment with radiation, chemotherapy, or steroids stronger than 5 mg of prednisolone.You have a history of a disease that affects your connective tissues.I haven't had any joint injections, like hyaluronic acid, in the last 3 months.
- Group 1: Investigational Group
- Group 2: Control Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is the program currently recruiting participants?
"Affirmative. Clinicaltrials.gov suggests this experiment is currently recruiting for participants, which was initially announced on August 26th 2020 and most recently updated on January 3rd 2022. The study requires the recruitment of 234 patients from 7 different medical sites."
To what extent has this trial recruited participants?
"Affirmative. This medical trial is still enrolling participants, as evidenced by the records on clinicaltrials.gov which were first posted on August 26th 2020 and edited most recently on January 3rd 2022. The study seeks to recruit 234 subjects from seven different sites across America."
Is this clinical research accommodating individuals older than 55 years of age?
"The age bracket that is eligible to partake in this trial sits between 18 and 55. However, there are 129 separate studies dedicated to minors and 608 clinical trials for seniors."
Do I conform to the criteria for enrollment in this inquiry?
"Those with chondromalacia and aged between 18-55 may register for this clinical trial, which is slated to accept 234 participants."
Can you tell me how many Canadian medical facilities are engaging in this clinical research?
"This study is recruiting participants across 7 different sites, amongst them St. Joseph's Healthcare Hamilton in Hamilton, MedStar Orthopaedics Institute in Timonium and CORE Orthopaedic Medical Center in Encinitas."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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