Clinical trial NCT03197428: Platelet-rich Plasma for Chronic Lateral Ankle Instability
Official title: Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Instability
Platelet-rich Plasma
Keywords: Platelet-Rich Plasma
Ankle Injuries
Lateral Ligament, Ankle
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2017-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
timeFrame: 3-month postoperative
Secondary outcomes:
measure: 3-month postoperative ankle pain evaluated by visual analogue scale
timeFrame: 3-month postoperative
measure: 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test
timeFrame: 3-month postoperative
measure: 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test
timeFrame: 3-month postoperative
measure: Percentage of patients with healed ligament evaluated by MRI
timeFrame: 3-month postoperative
measure: Percentage of patients with healed ligament evaluated by second look arthroscopy
timeFrame: 3-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: