Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04950335
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT
Sponsor:
Peking University Third Hospital
Organization:
Study Overview
Official Title:
Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.
Detailed Description:
From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (\>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: