Platelet-rich Plasma for Chronic Lateral Ankle Instability

Pei-Yuan Lee, MD

Status: Completed

Conditions: Platelet-rich Plasma; Ankle Instability

Treatments: Other: Control; Other: Platelet-rich plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03197428

RA-16026-RD-105066

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

PRP group

Experimental group

Description:

15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Treatment:

Other: Platelet-rich plasma

Control group

Placebo Comparator group

Description:

15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Treatment:

Other: Control