Knee Injuries, Meniscus Disorder, Platelet-Rich Plasma
Conditions
Keywords
Platelet-Rich Plasma, Meniscus, Knee Injuries
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.
Interventions
OTHERplatelet-rich plasma
Autologous platelet-rich plasma gel applied during meniscus repair surgery
OTHERcontrol
Meniscus repair surgery only
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month postoperative knee function evaluated by IKDC | 3-month postoperative | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with healed meniscus 6-month postoperative | 6-month postoperative | Healing of meniscus is evaluated by MRI |
| 6-month postoperative knee function evaluated by IKDC | 6-month postoperative | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. |
| 12-month postoperative knee function evaluated by IKDC | 12-month postoperative | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. |
| 12-month postoperative knee pain evaluated by VAS | 12-month postoperative | Pain level is evaluated using visual analogue scale (VAS). |
| 6-month postoperative knee pain evaluated by VAS | 6-month postoperative | Pain level is evaluated using visual analogue scale (VAS). |
| Percentage of patients with healed meniscus 12-month postoperative | 12-month postoperative | Healing of meniscus is evaluated by MRI |
| 3-month postoperative knee pain evaluated by VAS | 3-month postoperative | Pain level is evaluated using visual analogue scale (VAS). |
Countries
Taiwan
Outcome results
None listed