Osteochondral DefectNCT03696394
A Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects
A study testing BioCartilage® Micronized Cartilage Matrix in people with Osteochondral Defect, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial 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 BioCartilage® Micronized Cartilage Matrix. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- BioCartilage® Micronized Cartilage Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2019to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment.
- 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.
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits.
- The subject is at least nineteen (19) years of age and considered to be skeletally mature.
- The subject has a combined bone and cartilage defect as determined by an MRI.
- The patient has a stable ankle joint on history and has similar ligament stability with the opposite ankle.
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- The subject has less than 15 degrees of hindfoot valgus and 5 degrees of hindfoot varus.
- The subject has a chronic defect not secondary to acute trauma within the last 6 months.
- The patient (if having suffered a fracture) has no residual deformity of the tibia, fibula or syndesmosis.
- The subject has a BMI of ≤ 40 kg/m².
- The subject has exhausted non-operative treatment.
- The subject has symptoms for less than a year.
- Lesions on the subject must be contained.
Who cannot join
- The subject has over 15 degrees of hindfoot valgus or 5 degrees of hindfoot varus.
- The subject has an isolated OCD with dimensions greater than 2.0 cm2 on an MRI assessment.
- The subject has an allergy to yeast-derived products.
- 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.
- The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the foot.
- 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 BioCartilage® site.
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- 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.
- The subject is a prisoner, or is known or suspected to be transient.
- The subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry.
- The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period.
- The subject currently has an acute infection in the area surrounding the surgical site.
- The subject has a history of anaphylaxis or of multiple non-environmental allergies that may precipitate an anaphylactic reaction.
- The subject's condition is bilateral and surgery is scheduled or to be scheduled over the course of this trial for both feet.
- The subject requires a concomitant osteotomy of the tibia, fibula, or calcaneus for hindfoot deformity.
- The subject requires a concomitant hindfoot fusion or has had a hindfoot fusion for hindfoot arthritis or deformity.
- The subject is undergoing any concomitant surgery that may invalidate the outcome scores such as forefoot surgery or fusions, tendon transfers or ligament reconstructions. Heel cord lengthening is permitted.
- The subject has an OCD of the tibia in isolation or in combination with the talar lesion
- The subject is addicted to nicotine and on nicotine containing medication such as gum or a patch; or using nicotine containing substances such as cigarettes, cigars, pipe smoking or chewing tobacco.
- The subject abuses cocaine or cocaine derivative drugs.
- The subject has a known hypersensitivity to aprotinin.
- The subject has diabetes with an HBA1c> 7.5.
- The subject is unable to give informed consent.
- The subject is unable to comply with follow-up.
- The subject is unable to communicate with the research team.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Biraj Bora, bbora@providencehealth.bc.ca
About this study
Official title: A Pilot Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects of the Talus
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 BioCartilage® Micronized Cartilage Matrix.
The purpose of this study is to assess whether adding BioCartilage® 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.
- Conditions
- Osteochondral Defect
- Being tested
- BioCartilage® Micronized Cartilage Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCartilage® Micronized Cartilage MatrixDevice
Also called BioCartilage®
BioCartilage® is a scaffold with Collagen Type II and cartilage matrix elements
| Study group | Role | What they receive |
|---|---|---|
| Group I | No intervention | Group I consists of 5 patients receiving a microfracture as per standard of care. |
| Group II | Active comparator | Group II consists of 10 patients receiving a microfracture with BioCartilage®. Receives: Device: BioCartilage® Micronized Cartilage Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes as Assessed by Ankle Osteoarthritis Scale (AOS)
This questionnaire assesses pain and difficulty in both the left and right ankle. The range for the Pain subscale is from 0 to 100 and the range for the Difficulty subscale is 0 to 100. The range for the Total score (average of Pain and Difficulty) is 0 to 100. Lower values for Pain, Difficulty, and Total is considered better.
The scores will be compared to each other to analyze the change in pain and difficulty from the baseline (within 21 days of surgery) to the end (2 years post-op).
Measured: 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.
Secondary outcomes (6)
Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) including Short Form 36 Health Survey (SF-36)
This questionnaire assesses multiple aspects patient health such as comorbidities, expectations/satisfaction, physical component score and mental component score. These measures and scores are values on a unitless scale.
Measured: 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.
Foot and Ankle Ability Measure (FAAM)
This questionnaire assesses activities of daily living and sports subscales. Both subscales range from "Unable to Do", which indicates a minimum score of 0, to "No Difficulty", which indicates a maximum score of 4. A better outcome would be a higher score for both subscales.
There is one last questions which asks the patient about their current level of function during their usual activities of daily living (daily living subscale) and sports (sports subscale). For both subscales, the range is from a minimum of 0% to a maximum of 100%. A better outcome score would be a higher score for both subscales.
Both of these subscales are not combined to compute a total score.
Measured: 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.
Visual Analog Scale
This questionnaire assesses the current level of pain in the foot/ankle that was treated. This scale ranges from "No Pain", which indicates a minimum score of 0, to "Worst Pain", which indicates a maximum score of 10. A better outcome would be a lower score.
Measured: 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.
X-ray radiographic assessments performed pre-operatively and post-operatively
X-rays will be completed to assess osteochondral healing.
Measured: 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.
CT radiographic assessments performed pre-operatively and post-operatively
CTs will be completed to assess osteochondral healing.
Measured: There are 2 assessment time points: within 21 days of surgery and 2 years post-op.
MRI radiographic assessments performed pre-operatively and post-operatively
MRIs will be completed to assess osteochondral healing.
Measured: There are 2 assessment time points: within 21 days of surgery and 2 years post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start29 Jan 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups. Group I consists of 5 patients receiving Microfracture as per standard of care (Control Group). Group II consists of 10 patients receiving Microfracture with BioCartilage® (Investigational Group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Andrea Veljkovic, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696394
- Sponsor's protocol ID
- ART - BioCartilage
- Other IDs
- H18-00603
- Status last verified
- Apr 2019
- First submitted
- 1 Oct 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects of the Talus
- ClinicalTrials.gov ID
- NCT03696394
- Acronym / sponsor ID
- ART - BioCartilage
- Conditions
- Osteochondral Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 BioCartilage® Micronized Cartilage Matrix.
The purpose of this study is to assess whether adding BioCartilage® 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups. Group I consists of 5 patients receiving Microfracture as per standard of care (Control Group). Group II consists of 10 patients receiving Microfracture with BioCartilage® (Investigational Group).
| Arm | Type | Receives |
|---|---|---|
| Group I | No intervention | –Group I consists of 5 patients receiving a microfracture as per standard of care. |
| Group II | Active comparator | Device: BioCartilage® Micronized Cartilage MatrixGroup II consists of 10 patients receiving a microfracture with BioCartilage®. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment.
- 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.
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits.
- The subject is at least nineteen (19) years of age and considered to be skeletally mature.
- The subject has a combined bone and cartilage defect as determined by an MRI.
Key exclusion criteria (24 listed)
- The subject has over 15 degrees of hindfoot valgus or 5 degrees of hindfoot varus.
- The subject has an isolated OCD with dimensions greater than 2.0 cm2 on an MRI assessment.
- The subject has an allergy to yeast-derived products.
- 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.
- The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the foot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioCartilage® Micronized Cartilage MatrixAlso: BioCartilage®BioCartilage® is a scaffold with Collagen Type II and cartilage matrix elements | Device | Group II |
Primary outcome
Changes as Assessed by Ankle Osteoarthritis Scale (AOS)
Time frame: 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.
This questionnaire assesses pain and difficulty in both the left and right ankle. The range for the Pain subscale is from 0 to 100 and the range for the Difficulty subscale is 0 to 100. The range for the Total score (average of Pain and Difficulty) is 0 to 100. Lower values for Pain, Difficulty, and Total is considered better. The scores will be compared to each other to analyze the change in pain and difficulty from the baseline (within 21 days of surgery) to the end (2 years post-op).
6 secondary outcomes
Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) including Short Form 36 Health Survey (SF-36)
Time frame: 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.
Foot and Ankle Ability Measure (FAAM)
Time frame: 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.
Visual Analog Scale
Time frame: 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.
X-ray radiographic assessments performed pre-operatively and post-operatively
Time frame: 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.
CT radiographic assessments performed pre-operatively and post-operatively
Time frame: There are 2 assessment time points: within 21 days of surgery and 2 years post-op.
MRI radiographic assessments performed pre-operatively and post-operatively
Time frame: There are 2 assessment time points: within 21 days of surgery and 2 years post-op.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioCartilage® Micronized Cartilage Matrix in people with Osteochondral Defect, run by St. Paul's Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biraj Bora (6048068743, bbora@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes as Assessed by Ankle Osteoarthritis Scale (AOS) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.