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Platelet-rich Plasma for Meniscus Repair

NCT ID: NCT03176641

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-24

Study Completion Date

2018-11-21

Brief Summary

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This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only.

Detailed Description

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Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. Additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. 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 in orthopedic and oral surgery. Several in vivo and in vitro studies have reported favorable outcomes of PRP on meniscal repair; however, the clinical results varied between studies.This clinical trial will investigate the effect of PRP on on meniscus injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical outcomes will be compared and analyzed.

Conditions

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Platelet-Rich Plasma Knee Injuries Meniscus Disorder

Keywords

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Platelet-Rich Plasma Meniscus Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRP group

30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.

Group Type ACTIVE_COMPARATOR

platelet-rich plasma

Intervention Type OTHER

Autologous platelet-rich plasma gel applied during meniscus repair surgery

Control group

30 patients will receive meniscus repair surgery only.

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

Meniscus repair surgery only

Interventions

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platelet-rich plasma

Autologous platelet-rich plasma gel applied during meniscus repair surgery

Intervention Type OTHER

control

Meniscus repair surgery only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 60 years
* With diagnosis of meniscus injury
* With indications of meniscus repair surgery

Exclusion Criteria

* Multiple ligaments injury
* with prior history of knee surgery
* Cancer patients
* Pregnancy
* Patients who will not cooperate with one-year followup
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aeon Biotechnology Corporation

INDUSTRY

Sponsor Role collaborator

Pei-Yuan Lee, MD

OTHER

Sponsor Role lead

Responsible Party

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Pei-Yuan Lee, MD

Superintendent

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pei-Yuan Lee, MD

Role: STUDY_CHAIR

Show Chwan Memorial Hospital

Locations

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Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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RA-16027-RD-105063

Identifier Type: -

Identifier Source: org_study_id