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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211119

Enrollment

Registered

2010-09-29

Start date

2011-01-31

Completion date

2013-12-31

Last updated

2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniscal Injuries

Brief 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.

Interventions

OTHERNo PRF

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

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
MRI T2-map values in healing menisci	one-month

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026