Show Chwan Memorial Hospital
Changhua, 500, Taiwan
NCT Number: NCT03197428
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.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Changhua, 500, Taiwan
Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been linked to recurrent ankle pain, swelling, and even early degenerative change if not properly treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the mainstream in treatment of CAI. Early mobilization is related to better functional outcome, and rapid healing of the repair is the key point to shorten the immobilization time. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The postoperative imaging and clinical outcomes will be compared and analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Time frame: 3-month postoperative
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
Time frame: 3-month postoperative
Ankle pain is evaluated by visual analogue scale
Time frame: 3-month postoperative
Anterior displacement is evaluated by the anterior displacement of the talus relative to the tibia on stress radiographs of anterior drawer test.
Time frame: 3-month postoperative
Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test.
Time frame: 3-month postoperative
Healing condition of ligament is assessed by MRI.
Time frame: 3-month postoperative
Healing condition of ligament is assessed by second look arthroscopy.
Pei-Yuan Lee, MD
Other
Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
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