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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01211119
First received: September 20, 2010
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

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

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211119

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

No publications provided

Responsible Party: Wing P. Chan, Wan Fang Hospital Department of Radiology
ClinicalTrials.gov Identifier: NCT01211119     History of Changes
Other Study ID Numbers: 99022
Study First Received: September 20, 2010
Last Updated: April 21, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014