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Clinical Trials/NCT03176641
NCT03176641
Completed
Not Applicable

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

Pei-Yuan Lee, MD1 site in 1 country60 target enrollmentAugust 24, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Platelet-Rich Plasma
Sponsor
Pei-Yuan Lee, MD
Enrollment
60
Locations
1
Primary Endpoint
3-month postoperative knee function evaluated by IKDC
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2016
End Date
November 21, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pei-Yuan Lee, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Pei-Yuan Lee, MD

Superintendent

Show Chwan Memorial Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 6-month postoperative knee function evaluated by IKDC(6-month postoperative)
  • 3-month postoperative knee pain evaluated by VAS(3-month postoperative)
  • Percentage of patients with healed meniscus 6-month postoperative(6-month postoperative)
  • Percentage of patients with healed meniscus 12-month postoperative(12-month postoperative)
  • 6-month postoperative knee pain evaluated by VAS(6-month postoperative)
  • 12-month postoperative knee pain evaluated by VAS(12-month postoperative)
  • 12-month postoperative knee function evaluated by IKDC(12-month postoperative)

Study Sites (1)

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