Clinical Trials Directory

Trials / Unknown

UnknownNCT01211119

Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
Taipei Medical University WanFang Hospital · Academic / Other
Sex
All
Age
20 Years – 45 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERNo PRFGroup B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only

Timeline

Start date
2011-01-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2010-09-29
Last updated
2011-04-26

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT01211119. Inclusion in this directory is not an endorsement.