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Cartilage Matrix
Group II for Osteochondral Defect
N/A
Waitlist Available
Research Sponsored by St. Paul's Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up there are 6 assessment time points: within 21 days of surgery, 6 weeks post-op, 12 weeks post-op, 6 months post-op, 1 year post-op and 2 years post-op.
Awards & highlights
Study Summary
This trial tests whether adding a cartilage matrix product to microfracture treatment of ankle cartilage defects improves healing and pain/function.
Eligible Conditions
- Osteochondral Defect
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome will be administered 6 times per patient: within 21 days of surgery, 6 weeks post-op, 12 weeks post-op, 6 months post-op, 1 year post-op and 2 years post-op.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome will be administered 6 times per patient: within 21 days of surgery, 6 weeks post-op, 12 weeks post-op, 6 months post-op, 1 year post-op and 2 years post-op.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes as Assessed by Ankle Osteoarthritis Scale (AOS)
Secondary outcome measures
CT radiographic assessments performed pre-operatively and post-operatively
Ankle
MRI radiographic assessments performed pre-operatively and post-operatively
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Group IIActive Control1 Intervention
Group II consists of 10 patients receiving a microfracture with BioCartilage®.
Group II: Group IActive Control1 Intervention
Group I consists of 5 patients receiving a microfracture as per standard of care.
Find a Location
Who is running the clinical trial?
St. Paul's Hospital, CanadaLead Sponsor
44 Previous Clinical Trials
12,705 Total Patients Enrolled
Arthrex, Inc.Industry Sponsor
44 Previous Clinical Trials
29,867 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced severe allergic reactions in the past or have multiple allergies that could potentially cause a severe allergic reaction.Your body mass index (BMI) is less than or equal to 40 kg/m².You have a long-term injury or condition that is not caused by recent sudden injury.You have a fear of confined spaces (claustrophobia) that would make it difficult for you to have an MRI scan of your foot.You need surgery to correct a deformity in your ankle, foot, or heel.Your foot is severely tilted inward or outward by more than a certain amount.You are allergic to products derived from yeast.You use cocaine or drugs made from cocaine.Your ankle has been stable in the past and has similar ligament strength as your other ankle.If you had a broken leg before, it should have healed properly without any permanent changes in the shape of your tibia, fibula, or syndesmosis.You have hindfoot arthritis or deformity and need or have already had surgery to fuse the hindfoot bones.You are allergic to aprotinin.You are currently using nicotine products like gum, patches, cigarettes, cigars, pipe smoking, or chewing tobacco.You have a specific type of bone disorder in your leg called a tibial OCD, either alone or combined with a talar lesion.
Research Study Groups:
This trial has the following groups:- Group 1: Group II
- Group 2: Group I
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.
Is enrollment for this study still available to participants?
"Affirmative. The information posted on clinicaltrials.gov verifies that this research is actively seeking participants, with the first posting having been made on January 29th 2019 and most recently updated April 2nd of last year. This study requires 15 individuals to be recruited from 1 medical centre."
Answered by AI
How many participants are included in the clinical trial?
"Affirmative. According to information located on clinicaltrials.gov, this medical experiment is still searching for participants since its initial posting on January 29th 2019 and the latest update being April 2nd 2019. The study requires 15 patients from a single location."
Answered by AI
Who else is applying?
What site did they apply to?
St. Paul's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Since the first surgery was not successful I am looking for other options that might have better long term outcomes.
PatientReceived no prior treatments
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