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| Name | Class |
|---|---|
| Aeon Biotechnology Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP group | Experimental | 15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament. |
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| Control group | Placebo Comparator | 15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma | Other | Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pei-Yuan Lee, MD | Show Chwan Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Show Chwan Memorial Hospital | Changhua | Changhua | 500 | Taiwan |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Control | Other | Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament |
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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 |