Platelet-rich Plasma for Meniscus Repair
Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2018
CompletedDecember 26, 2018
December 1, 2018
1.7 years
April 13, 2017
December 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-month postoperative knee function evaluated by IKDC
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
3-month postoperative
Secondary Outcomes (7)
6-month postoperative knee function evaluated by IKDC
6-month postoperative
12-month postoperative knee function evaluated by IKDC
12-month postoperative
3-month postoperative knee pain evaluated by VAS
3-month postoperative
6-month postoperative knee pain evaluated by VAS
6-month postoperative
12-month postoperative knee pain evaluated by VAS
12-month postoperative
- +2 more secondary outcomes
Study Arms (2)
PRP group
ACTIVE COMPARATOR30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.
Control group
PLACEBO COMPARATOR30 patients will receive meniscus repair surgery only.
Interventions
Autologous platelet-rich plasma gel applied during meniscus repair surgery
Eligibility Criteria
You may qualify if:
- Age between 20 and 60 years
- With diagnosis of meniscus injury
- With indications of meniscus repair surgery
You may not qualify if:
- Multiple ligaments injury
- with prior history of knee surgery
- Cancer patients
- Pregnancy
- Patients who will not cooperate with one-year followup
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pei-Yuan Lee, MDlead
- Aeon Biotechnology Corporationcollaborator
Study Sites (1)
Show Chwan Memorial Hospital
Changhua, Changhua, 500, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pei-Yuan Lee, MD
Show Chwan Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Superintendent
Study Record Dates
First Submitted
April 13, 2017
First Posted
June 5, 2017
Study Start
August 24, 2016
Primary Completion
May 8, 2018
Study Completion
November 21, 2018
Last Updated
December 26, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share