Meniscal Injuries Clinical Trial
Official title:
Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
Verified date | April 2011 |
Source | Taipei Medical University WanFang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by
suture repair when it is possible. Recently, the investigators have successfully developed
and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage
defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to
the development of microvascularization and enables local and progressive delivery of growth
factors providing unique properties for tissue remodeling and wound healing. The advantages
of using PRF implantation include no transplant rejection and no need to perform second
operation. Knee meniscal repair using PRF has not been reported before. The aim of this
study is to investigate whether PRF implantation can facilitate regeneration process of
meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal
tears.
A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus)
will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after
partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C
(n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with
surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.
The investigators believe that PRF enables to facilitate regeneration of meniscectomized
knee, and T2-map MRI enables monitoring healing process of meniscal tears.
Status | Enrolling by invitation |
Enrollment | 18 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 20 to 45 years old; - time of injury to surgery within 8 weeks - patients who will sign inform consent - patients with clinical and MRI diagnosis of meniscal tears who will undergo arthroscopy - patients who will make MRI diagnosis at 3, 6, 12 months Exclusion Criteria: - major trauma - coexist ligamentous rupture - knee dislocations |
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University-Wan Fang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University WanFang Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI T2-map values in healing menisci | one-month | Yes |