Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
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|ClinicalTrials.gov Identifier: NCT01211119|
Recruitment Status : Unknown
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was: Enrolling by invitation
First Posted : September 29, 2010
Last Update Posted : April 26, 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 or disease||Intervention/treatment||Phase|
|Meniscal Injuries||Other: No PRF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
|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
- MRI T2-map values in healing menisci [ Time Frame: one-month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211119
|Taipei Medical University-Wan Fang Hospital|
|Principal Investigator:||Wing P. Chan||Taipei Medical University-Wan Fang Hospital|