Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 26, 2011
April 1, 2011
2.9 years
September 20, 2010
April 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
MRI T2-map values in healing menisci
one-month
Study Arms (1)
platelet-rich fibrin, PRF
EXPERIMENTALInterventions
Group B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- major trauma
- coexist ligamentous rupture
- knee dislocations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Wing P. Chan
Taipei Medical University-Wan Fang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 20, 2010
First Posted
September 29, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 26, 2011
Record last verified: 2011-04