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

Meniscal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01211119
• Other study ID #: 99022
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 20, 2010
• Last updated: April 21, 2011
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniscal Injuries

Intervention

Other:
• No PRF
Group B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI T2-map values in healing menisci		one-month	Yes