Platelet-rich Plasma for Chronic Lateral Ankle Instability

NCT ID: NCT03197428

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-05
• Study Completion Date: 2019-01-31

Brief Summary

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.

Detailed 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.

Conditions

Ankle Instability; Platelet-rich Plasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRP group

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

Group Type: EXPERIMENTAL

Platelet-rich plasma

Intervention Type: OTHER

Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Control group

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Interventions

Platelet-rich plasma

Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Intervention Type: OTHER

Control

Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeon Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Pei-Yuan Lee, MD

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yuan Lee, MD

Superintendent

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pei-Yuan Lee, MD

Role: STUDY_CHAIR

Show Chwan Memorial Hospital

Locations

Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Countries

Taiwan

Other Identifiers

RA-16026-RD-105066

Identifier Type: -

Identifier Source: org_study_id