Ankle Instability, Platelet-rich Plasma
Conditions
Keywords
Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle
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.
Interventions
OTHERPlatelet-rich plasma
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
OTHERControl
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Sponsors
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score | 3-month postoperative | Ankle function is evaluated by AOFAS Ankle-Hindfoot score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-month postoperative ankle pain evaluated by visual analogue scale | 3-month postoperative | Ankle pain is evaluated by visual analogue scale |
| 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test | 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-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test | 3-month postoperative | Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test. |
| Percentage of patients with healed ligament evaluated by MRI | 3-month postoperative | Healing condition of ligament is assessed by MRI. |
| Percentage of patients with healed ligament evaluated by second look arthroscopy | 3-month postoperative | Healing condition of ligament is assessed by second look arthroscopy. |
Countries
Taiwan
Outcome results
None listed