Platelet-rich Plasma for Chronic Lateral Ankle Instability

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

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.

Study Overview

• Status: Completed
• Conditions: Platelet-rich Plasma; Ankle Instability
• Intervention / Treatment: Other: Platelet-rich plasma; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Show Chwan Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRP group; 15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.	Other: Platelet-rich plasma; Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
PLACEBO_COMPARATOR: Control group; 15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.	Other: Control; Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score	Ankle function is evaluated by AOFAS Ankle-Hindfoot score	3-month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month postoperative ankle pain evaluated by visual analogue scale	Ankle pain is evaluated by visual analogue scale	3-month postoperative
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
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
Percentage of patients with healed ligament evaluated by MRI	Healing condition of ligament is assessed by MRI.	3-month postoperative
Percentage of patients with healed ligament evaluated by second look arthroscopy	Healing condition of ligament is assessed by second look arthroscopy.	3-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2016
• Primary Completion (ACTUAL): January 12, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (ACTUAL): June 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Platelet-Rich Plasma; Ankle Injuries; Lateral Ligament, Ankle
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: RA-16026-RD-105066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No