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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.
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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
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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.
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