Collagen patch boosts ankle cartilage repair in new trial
NCT ID NCT02519881
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested whether adding a collagen device (CartiFill) during microfracture surgery helps heal ankle cartilage defects better than microfracture alone. Sixty patients were enrolled and followed for up to two years. The main goal was to measure pain and satisfaction after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CartiFill (collagen device) used during microfracture surgery
- What this could lead to
- If it works, this could improve pain and healing for people with ankle cartilage damage, offering a better surgical option.
- What could go wrong
- This is a small, completed trial with 60 participants. The results may not apply to everyone, and the collagen device may not provide significant benefit over standard microfracture.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Feb 2014
- Finished
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Jan 2018
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients who were 15 years old or older 2. Patients with cartilage defects in their ankle 3. Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment 4. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form Exclusion Criteria: 1. If patients or their families suffer from or have ever suffered from an autoimmune disease. 2. Patients who have ever suffered an anaphylactic reaction. 3. Patients who have ever suffered hypersensitivity to an implant. 4. Patients with a history of allergy to porcine or bovine protein. 5. Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis. 6. Subjects with autoimmune disease related arthritis. 7. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy. 8. Subjects with tumors. 9. Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision). 10. Subjects who are diabetic. (Exception: if the possibility of CartiFill™ treatment is confirmed with doctor's clinical decision, and/or patient's blood glucose level remains within the normal range and/or no other complications by diabetes mellitus.) 11. Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision). 12. Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision). 13. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator. 14. Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows: patients with hypersensitivity to aprotinin and those treatments for severe brisk arterial or venous bleeding.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Eulji general Hospital
Seoul, Seoul, South Korea
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Hallym University Medical Center-Kangnam Sacred Heart Hospital
Seoul, Seoul, South Korea
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
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