Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 3-month postoperative knee function evaluated by IKDC
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
30 patients will receive meniscus repair surgery only.
Intervention: control (Other)
PRP group
30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.
Intervention: platelet-rich plasma (Other)
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
- 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 function evaluated by IKDC(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)
- 6-month postoperative knee pain evaluated by VAS(6-month postoperative)
Investigators
Pei-Yuan Lee, MD
Superintendent
Show Chwan Memorial Hospital