Platelet-rich Plasma for Meniscus Repair

Not Applicable

Completed

• Conditions: Knee Injuries; Platelet-Rich Plasma; Meniscus Disorder
• Interventions: Other: control; Other: platelet-rich plasma

• Registration Number: NCT03176641
• Lead Sponsor: Pei-Yuan Lee, MD

Brief 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.

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 Timeline

• Study Start: 2016-08-24
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Primary Completion: 2018-05-08
• Study Completion: 2018-11-21
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-22
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	control	30 patients will receive meniscus repair surgery only.
PRP group	platelet-rich plasma	30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.

Primary Outcome Measures

Name	Time	Method
3-month postoperative knee function evaluated by IKDC	3-month postoperative	Knee function is evaluated using International Knee Documentation Committee (IKDC) score.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Show Chwan Memorial Hospital; 🇨🇳 Changhua City, Changhua, Taiwan