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Completed

NCT Number: NCT03197428

Platelet-rich Plasma for 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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich plasma

Other

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

Control

Other

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

Primary outcomes

  1. 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score

    Time frame: 3-month postoperative

    Ankle function is evaluated by AOFAS Ankle-Hindfoot score

Secondary outcomes

  1. 3-month postoperative ankle pain evaluated by visual analogue scale

    Time frame: 3-month postoperative

    Ankle pain is evaluated by visual analogue scale

  2. 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test

    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.

  3. 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test

    Time frame: 3-month postoperative

    Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test.

  4. Percentage of patients with healed ligament evaluated by MRI

    Time frame: 3-month postoperative

    Healing condition of ligament is assessed by MRI.

  5. Percentage of patients with healed ligament evaluated by second look arthroscopy

    Time frame: 3-month postoperative

    Healing condition of ligament is assessed by second look arthroscopy.

Sponsors and collaborators

Lead sponsor

Pei-Yuan Lee, MD

Other

Collaborators

  • Aeon Biotechnology Corporation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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