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The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfracture with PRP | Experimental | Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local injection: PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope. |
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| Isolated microfracture | Active Comparator | Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic microfracture with intraoperative local PRP gel injection | Procedure | Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local injection: PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope. |
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopedic Foot and Ankle Society Score (AOFAS) | The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery. | Pre-surgery and 3, 6, 12 and 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Outcome Score (FAOS) | The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. | Pre-surgery and 3, 6, 12 and 24 months after surgery |
| Ankle Activity Score (AAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinwei Guo, MD | Contact | +86 18601129252 | guoqinwei@vip.sina.com | |
| Fengyi Hu, MD | Contact | +86 13335511505 | hfy1322@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qinwei Guo, MD | Department of Sports Medicine, Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
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| Isolated microfracture | Procedure | Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. |
|
The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. |
| Pre-surgery and 3, 6, 12 and 24 months after surgery |
| Visual Analogue Scale (VAS) | The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. | Pre-surgery and 3, 6, 12 and 24 months after surgery |
| Patient Satisfaction | Patient satisfaction will be graded as 0-10 and collected 24 months after surgery. | Final follow-up (24 months after surgery) |
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) | MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery. | Twelve and 24 months after surgery |
| Return-to-Sport Rate | The rate and time point of participants returning to sports will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery. | Final follow-up (24 months after surgery) |
| Complications | Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery. | Final follow-up (24 months after surgery) |
| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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