Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear

MCL Tear Clinical Trial

Official title:

Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00743886
• Other study ID #: 5000
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: August 28, 2008
• Last updated: July 10, 2011
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Description:

Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• age 18-40 years old

• diagnosed MCL tear grade 2/3

Exclusion Criteria:

• pregnancy

• mental or physical disabilities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• MCL Tear

Intervention

Biological:
• Plasma Rich in Growth Factors (PRGF)
injection onto injured area in ligament dose: 3-6mg

Drug:
• saline
injection of 6 cc of saline into injured area

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time and efficiency of healing		1 year	Yes