Platelet-rich Plasma for Chronic Lateral Ankle Instability
Primary Purpose
Ankle Instability, Platelet-rich Plasma
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-rich plasma
Control
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Instability focused on measuring Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle
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
Sites / Locations
- Show Chwan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRP group
Control group
Arm Description
15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
Outcomes
Primary Outcome Measures
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
Secondary Outcome Measures
3-month postoperative ankle pain evaluated by visual analogue scale
Ankle pain is evaluated by visual analogue scale
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 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.
Percentage of patients with healed ligament evaluated by MRI
Healing condition of ligament is assessed by MRI.
Percentage of patients with healed ligament evaluated by second look arthroscopy
Healing condition of ligament is assessed by second look arthroscopy.
Full Information
NCT ID
NCT03197428
First Posted
April 13, 2017
Last Updated
April 2, 2019
Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03197428
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
January 12, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Instability, Platelet-rich Plasma
Keywords
Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP group
Arm Type
Experimental
Arm Description
15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Primary Outcome Measure Information:
Title
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
Description
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
Time Frame
3-month postoperative
Secondary Outcome Measure Information:
Title
3-month postoperative ankle pain evaluated by visual analogue scale
Description
Ankle pain is evaluated by visual analogue scale
Time Frame
3-month postoperative
Title
3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test
Description
Anterior displacement is evaluated by the anterior displacement of the talus relative to the tibia on stress radiographs of anterior drawer test.
Time Frame
3-month postoperative
Title
3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test
Description
Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test.
Time Frame
3-month postoperative
Title
Percentage of patients with healed ligament evaluated by MRI
Description
Healing condition of ligament is assessed by MRI.
Time Frame
3-month postoperative
Title
Percentage of patients with healed ligament evaluated by second look arthroscopy
Description
Healing condition of ligament is assessed by second look arthroscopy.
Time Frame
3-month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yuan Lee, MD
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Platelet-rich Plasma for Chronic Lateral Ankle Instability
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