Platelet-rich Plasma for Chronic Lateral Ankle Instability

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ankle Instability, Platelet-rich Plasma

Intervention / Treatment
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* Other: Platelet-rich plasma
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament. | Other: Platelet-rich plasma<br>* Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament<br>|
| Placebo Comparator: Control group<br>15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament. | Other: Control<br>* Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle