Platelet-rich Plasma for Meniscus Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; Platelet-Rich Plasma; Meniscus Disorder
• Intervention / Treatment: Other: platelet-rich plasma; Other: control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Show Chwan Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP group; 30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.	Other: platelet-rich plasma; Autologous platelet-rich plasma gel applied during meniscus repair surgery
Placebo Comparator: Control group; 30 patients will receive meniscus repair surgery only.	Other: control; Meniscus repair surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month postoperative knee function evaluated by IKDC	Knee function is evaluated using International Knee Documentation Committee (IKDC) score.	3-month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month postoperative knee function evaluated by IKDC	Knee function is evaluated using International Knee Documentation Committee (IKDC) score.	6-month postoperative
12-month postoperative knee function evaluated by IKDC	Knee function is evaluated using International Knee Documentation Committee (IKDC) score.	12-month postoperative
3-month postoperative knee pain evaluated by VAS	Pain level is evaluated using visual analogue scale (VAS).	3-month postoperative
6-month postoperative knee pain evaluated by VAS	Pain level is evaluated using visual analogue scale (VAS).	6-month postoperative
12-month postoperative knee pain evaluated by VAS	Pain level is evaluated using visual analogue scale (VAS).	12-month postoperative
Percentage of patients with healed meniscus 6-month postoperative	Healing of meniscus is evaluated by MRI	6-month postoperative
Percentage of patients with healed meniscus 12-month postoperative	Healing of meniscus is evaluated by MRI	12-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Meniscus; Platelet-Rich Plasma; Knee Injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: RA-16027-RD-105063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No