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Platelet-rich Plasma for Meniscus Repair

Primary Purpose

Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet-rich plasma
control
Sponsored by
Pei-Yuan Lee, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet-Rich Plasma focused on measuring Platelet-Rich Plasma, Meniscus, Knee Injuries

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Show Chwan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PRP group

Control group

Arm Description

30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.

30 patients will receive meniscus repair surgery only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2017
Last Updated
December 22, 2018
Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03176641
Brief Title
Platelet-rich Plasma for Meniscus Repair
Official Title
Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder
Keywords
Platelet-Rich Plasma, Meniscus, Knee Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Active Comparator
Arm Description
30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
30 patients will receive meniscus repair surgery only.
Intervention Type
Other
Intervention Name(s)
platelet-rich plasma
Intervention Description
Autologous platelet-rich plasma gel applied during meniscus repair surgery
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Meniscus repair surgery only
Primary Outcome Measure Information:
Title
3-month postoperative knee function evaluated by IKDC
Description
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Time Frame
3-month postoperative
Secondary Outcome Measure Information:
Title
6-month postoperative knee function evaluated by IKDC
Description
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Time Frame
6-month postoperative
Title
12-month postoperative knee function evaluated by IKDC
Description
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Time Frame
12-month postoperative
Title
3-month postoperative knee pain evaluated by VAS
Description
Pain level is evaluated using visual analogue scale (VAS).
Time Frame
3-month postoperative
Title
6-month postoperative knee pain evaluated by VAS
Description
Pain level is evaluated using visual analogue scale (VAS).
Time Frame
6-month postoperative
Title
12-month postoperative knee pain evaluated by VAS
Description
Pain level is evaluated using visual analogue scale (VAS).
Time Frame
12-month postoperative
Title
Percentage of patients with healed meniscus 6-month postoperative
Description
Healing of meniscus is evaluated by MRI
Time Frame
6-month postoperative
Title
Percentage of patients with healed meniscus 12-month postoperative
Description
Healing of meniscus is evaluated by MRI
Time Frame
12-month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yuan Lee, MD
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Platelet-rich Plasma for Meniscus Repair

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