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| ID | Type | Description | Link |
|---|---|---|---|
| H18-00603 | Other Identifier | UBC Providence Health Care Research Ethics Board |
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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCartilage® Micronized Cartilage Matrix | Device | BioCartilage® is a scaffold with Collagen Type II and cartilage matrix elements |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biraj Bora | Contact | 6048068743 | bbora@providencehealth.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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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).
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This study will be single-blinded. Group I and II subjects will be blinded as to whether they have received BioCartilage® in addition to Microfracture or Microfracture alone, as per standard of care. Investigators will be aware of the assigned treatment on the patients. Subjects will be aware of their assigned treatment after their surgery.
| 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. | 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. | 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. | 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. | 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. | There are 2 assessment time points: within 21 days of surgery and 2 years post-op. |