Platelet-rich Plasma Clinical Trial
Official title:
Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
Verified date | April 2019 |
Source | Show Chwan Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle instability by comparing the imaging and clinical outcomes between patients receiving PRP and those receiving whole blood during the modified Broström-Gould procedure.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Age between 20 and 60 years - With diagnosis of chronic lateral ankle instability Exclusion Criteria: - Poor controlled diabetes - Peripheral artery obstructive disease - Skin or soft tissue infection at ankle - With current or prior history of ankle disease, including degeneration arthritis, fracture, deformity, and cartilage disease. - With prior history of ankle surgery - With current or prior history of cancer - With current or prior history of hematological disease - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Taiwan | Show Chwan Memorial Hospital | Changhua City | Changhua |
Lead Sponsor | Collaborator |
---|---|
Pei-Yuan Lee, MD | Aeon Biotechnology Corporation |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score | Ankle function is evaluated by AOFAS Ankle-Hindfoot score | 3-month postoperative | |
Secondary | 3-month postoperative ankle pain evaluated by visual analogue scale | Ankle pain is evaluated by visual analogue scale | 3-month postoperative | |
Secondary | 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test | Anterior displacement is evaluated by the anterior displacement of the talus relative to the tibia on stress radiographs of anterior drawer test. | 3-month postoperative | |
Secondary | 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test | Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test. | 3-month postoperative | |
Secondary | Percentage of patients with healed ligament evaluated by MRI | Healing condition of ligament is assessed by MRI. | 3-month postoperative | |
Secondary | Percentage of patients with healed ligament evaluated by second look arthroscopy | Healing condition of ligament is assessed by second look arthroscopy. | 3-month postoperative |
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