NCT03197428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

April 13, 2017

Last Update Submit

April 2, 2019

Conditions

Ankle InstabilityPlatelet-rich Plasma

Keywords

Platelet-Rich PlasmaAnkle InjuriesLateral Ligament, Ankle

Outcome Measures

Primary Outcomes (1)

  • 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score

    Ankle function is evaluated by AOFAS Ankle-Hindfoot score

    3-month postoperative

Secondary Outcomes (5)

  • 3-month postoperative ankle pain evaluated by visual analogue scale

    3-month postoperative

  • 3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test

    3-month postoperative

  • 3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test

    3-month postoperative

  • Percentage of patients with healed ligament evaluated by MRI

    3-month postoperative

  • Percentage of patients with healed ligament evaluated by second look arthroscopy

    3-month postoperative

Study Arms (2)

PRP group

EXPERIMENTAL

15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Other: Platelet-rich plasma

Control group

PLACEBO COMPARATOR

15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament.

Other: Control

Interventions

Platelet-rich plasmaOTHER

Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament

PRP group
ControlOTHER

Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 60 years
  • With diagnosis of chronic lateral ankle instability

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Pei-Yuan Lee, MD

    Show Chwan Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Superintendent

Study Record Dates

First Submitted

April 13, 2017

First Posted

June 23, 2017

Study Start

July 5, 2016

Primary Completion

January 12, 2019

Study Completion

January 31, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)