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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meniscal Injuries

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet-rich fibrin, PRF

Group Type EXPERIMENTAL

No PRF

Intervention Type OTHER

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

Interventions

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No PRF

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

Intervention Type OTHER

Eligibility Criteria

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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