Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University Third Hospital
About this trial
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:
* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score? * Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.
Participants will:
* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel * Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment * Take MRI preoperatively and 6, 12 and 24 months after surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
Conservative treatment of at least 3 months fails to relieve symptoms;
Willingness to voluntarily participate in the trial and to sign informed consent.
Disqualifiers
Varus or valgus deformity of the ankle of more than 5 degrees;
Grade III injury of the lateral collateral ligament of ankle;
Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
Joint fibrosis, stiffness, and significantly restricted range of motion;
Trial design
Design model
Parallel
Treatments tested in this trial
Arthroscopic microfracture with intraoperative local PRP gel injection
Procedure/SurgeryArthroscopic 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.
Isolated microfracture
Procedure/SurgeryArthroscopic 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Microfracture with PRPExperimental treatment 1 intervention
Group B: Isolated microfractureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-surgery and 3, 6, 12 and 24 months after surgerySecondary outcomes
1
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.
Time frame
Pre-surgery and 3, 6, 12 and 24 months after surgery2
Ankle Activity Score (AAS)
The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.
Time frame
Pre-surgery and 3, 6, 12 and 24 months after surgery3
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.
Time frame
Pre-surgery and 3, 6, 12 and 24 months after surgery4
Patient Satisfaction
Patient satisfaction will be graded as 0-10 and collected 24 months after surgery.
Time frame
Final follow-up (24 months after surgery)Sponsors and contacts
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Source ClinicalTrials.gov