Clinical trial NCT03176641: Platelet-rich Plasma for Meniscus Repair
Official title: Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet-Rich Plasma
Knee Injuries
Meniscus Disorder
Keywords: Platelet-Rich Plasma
Meniscus
Knee Injuries
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2017-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-month postoperative knee function evaluated by IKDC
timeFrame: 3-month postoperative
Secondary outcomes:
measure: 6-month postoperative knee function evaluated by IKDC
timeFrame: 6-month postoperative
measure: 12-month postoperative knee function evaluated by IKDC
timeFrame: 12-month postoperative
measure: 3-month postoperative knee pain evaluated by VAS
timeFrame: 3-month postoperative
measure: 6-month postoperative knee pain evaluated by VAS
timeFrame: 6-month postoperative
measure: 12-month postoperative knee pain evaluated by VAS
timeFrame: 12-month postoperative
measure: Percentage of patients with healed meniscus 6-month postoperative
timeFrame: 6-month postoperative
measure: Percentage of patients with healed meniscus 12-month postoperative
timeFrame: 12-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: