Platelet-rich Plasma for Chronic Lateral Ankle Instability

Platelet-rich Plasma Clinical Trial

Official title:

Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197428
• Other study ID #: RA-16026-RD-105066
• Status: Completed
• Phase: N/A
• Start date: July 5, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ankle Instability
• Joint Instability
• Platelet-rich Plasma

Intervention

Other:
• Platelet-rich plasma
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
• Control
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

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