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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Enrolling by invitation
Information provided by:
Taipei Medical University WanFang Hospital Identifier:
First received: September 20, 2010
Last updated: April 21, 2011
Last verified: April 2011

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.

Condition Intervention
Meniscal Injuries
Other: No PRF

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Resource links provided by NLM:

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • MRI T2-map values in healing menisci [ Time Frame: one-month ]

Estimated Enrollment: 18
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platelet-rich fibrin, PRF Other: No PRF
Group B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01211119

Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Wing P. Chan Taipei Medical University-Wan Fang Hospital
  More Information

Responsible Party: Wing P. Chan, Wan Fang Hospital Department of Radiology Identifier: NCT01211119     History of Changes
Other Study ID Numbers: 99022
Study First Received: September 20, 2010
Last Updated: April 21, 2011 processed this record on April 27, 2017