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
Qualifiers
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
Treatments tested in this trial
- Arthroscopic microfracture with intraoperative local PRP gel injection
- Isolated microfracture
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov