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Platelet-rich Plasma for Chronic Lateral Ankle Instability

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ClinicalTrials.gov Identifier: NCT03197428
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Ankle Instability Platelet-rich Plasma Other: Platelet-rich plasma Other: Control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
Actual Study Start Date : July 5, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: PRP group
15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
Other: Platelet-rich plasma
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Placebo Comparator: Control group
15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.
Other: Control
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament




Primary Outcome Measures :
  1. 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score [ Time Frame: 3-month postoperative ]
    Ankle function is evaluated by AOFAS Ankle-Hindfoot score


Secondary Outcome Measures :
  1. 3-month postoperative ankle pain evaluated by visual analogue scale [ Time Frame: 3-month postoperative ]
    Ankle pain is evaluated by visual analogue scale

  2. 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test [ Time Frame: 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. 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test [ Time Frame: 3-month postoperative ]
    Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test.

  4. Percentage of patients with healed ligament evaluated by MRI [ Time Frame: 3-month postoperative ]
    Healing condition of ligament is assessed by MRI.

  5. Percentage of patients with healed ligament evaluated by second look arthroscopy [ Time Frame: 3-month postoperative ]
    Healing condition of ligament is assessed by second look arthroscopy.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197428


Contacts
Contact: Yan-Yu Chen, MD +886-975611186 swallowfish@gmail.com

Locations
Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Yan-Yu Chen, MD    +886-975611186    swallowfish@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

Responsible Party: Pei-Yuan Lee, MD, Superintendent, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03197428     History of Changes
Other Study ID Numbers: RA-16026-RD-105066
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Platelet-Rich Plasma
Ankle Injuries
Lateral Ligament, Ankle

Additional relevant MeSH terms:
Joint Instability
Joint Diseases
Musculoskeletal Diseases