A Study to Evaluate the Efficacy of BioCartilageĀ® Micronized Cartilage Matrix in Microfracture Trā¦ (NCT03696394) | Clinical Trial Compass
UnknownNot Applicable
A Study to Evaluate the Efficacy of BioCartilageĀ® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects
Canada15 participantsStarted 2019-01-29
Plain-language summary
The study was designed by the principal investigator, Dr. Andrea Veljkovic, and the St. Paul's Hospital Foot and Ankle Research Group, who will conduct the study. The study is being funded by Arthrex, Inc., the manufacturer of the Health Canada approved BioCartilageĀ® Micronized Cartilage Matrix.
The purpose of this study is to assess whether adding BioCartilageĀ® to microfracture treatment of osteochondral defects of the talus improves osteochondral healing as well as improving pain and function.
Efficacy will be assessed primarily by outcomes scores as measure by the Ankle Osteoarthritis Scale (AOS) at the baseline and at multiple post-op followup visits. Additional outcomes scores will also be administered to compare general health and foot function between the two groups at baseline and at multiple post-op followup visits. X-rays and MRI will be used to assess the osteochondral healing rate.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
ā. The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment.
ā. The subject has an isolated OCD with minimum dimensions of 0.07 cm2 (0.3 cm in diameter) and maximum dimensions of 2.25 cm2 as confirmed by a pre-op MRI.
ā. The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits.
ā. The subject is at least nineteen (19) years of age and considered to be skeletally mature.
ā. The subject has a combined bone and cartilage defect as determined by an MRI.
ā. The patient has a stable ankle joint on history and has similar ligament stability with the opposite ankle.
ā. The subject has less than 15 degrees of hindfoot valgus and 5 degrees of hindfoot varus.
ā. The subject has a chronic defect not secondary to acute trauma within the last 6 months.
Exclusion criteria
ā
What they're measuring
1
Changes as Assessed by Ankle Osteoarthritis Scale (AOS)
Timeframe: 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.
. The subject has over 15 degrees of hindfoot valgus or 5 degrees of hindfoot varus.
ā. The subject has an isolated OCD with dimensions greater than 2.0 cm2 on an MRI assessment.
ā. The subject has an allergy to yeast-derived products.
ā. The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips, or other electronically, magnetically or mechanically activated implants that would contraindicate an MRI scan of the foot.
ā. The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the foot.
ā. The subject has tested positive or has been treated for a malignancy in the past, is suspected of having a malignancy, or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed BioCartilageĀ® site.
ā. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the investigator judges the subject to be unable or unlikely to remain compliant to follow-up.
ā. The subject is a prisoner, or is known or suspected to be transient.