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Completed

NCT Number: NCT03176641

Platelet-rich Plasma for Meniscus Repair

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich plasma

Other

Autologous platelet-rich plasma gel applied during meniscus repair surgery

Control

Other

Meniscus repair surgery only

Primary outcomes

  1. 3-month postoperative knee function evaluated by IKDC

    Time frame: 3-month postoperative

    Knee function is evaluated using International Knee Documentation Committee (IKDC) score.

Secondary outcomes

  1. 6-month postoperative knee function evaluated by IKDC

    Time frame: 6-month postoperative

    Knee function is evaluated using International Knee Documentation Committee (IKDC) score.

  2. 12-month postoperative knee function evaluated by IKDC

    Time frame: 12-month postoperative

    Knee function is evaluated using International Knee Documentation Committee (IKDC) score.

  3. 3-month postoperative knee pain evaluated by VAS

    Time frame: 3-month postoperative

    Pain level is evaluated using visual analogue scale (VAS).

  4. 6-month postoperative knee pain evaluated by VAS

    Time frame: 6-month postoperative

    Pain level is evaluated using visual analogue scale (VAS).

  5. 12-month postoperative knee pain evaluated by VAS

    Time frame: 12-month postoperative

    Pain level is evaluated using visual analogue scale (VAS).

  6. Percentage of patients with healed meniscus 6-month postoperative

    Time frame: 6-month postoperative

    Healing of meniscus is evaluated by MRI

  7. Percentage of patients with healed meniscus 12-month postoperative

    Time frame: 12-month postoperative

    Healing of meniscus is evaluated by MRI

Sponsors and collaborators

Lead sponsor

Pei-Yuan Lee, MD

Other

Collaborators

  • Aeon Biotechnology Corporation

Registry information

Official study title

Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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