Platelet-rich Plasma for Meniscus Repair

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176641
• Other study ID #: RA-16027-RD-105063
• Status: Completed
• Phase: N/A
• Start date: August 24, 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: December 2018
• Source: Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Meniscus Disorder
• Platelet-Rich Plasma

Intervention

Other:
• platelet-rich plasma
Autologous platelet-rich plasma gel applied during meniscus repair surgery
• control
Meniscus repair surgery only

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

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