Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears

Achilles Tendon Tear Clinical Trial

Official title:

PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731068
• Other study ID #: 2000
• Secondary ID: MeirMc07om0090CT
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 5, 2008
• Last updated: October 23, 2013
• Start date: February 2007
• Est. completion date: March 2009

Study information

• Verified date: October 2013
• 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 review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.

Description:

Autologous platelet-rich matrices may aid in post surgical patients 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: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• A complete tear of Achilles tendon

• Age 18-50 years old

Exclusion Criteria:

• under 18 year of age

• pregnancy

• physical or mental disabilities

Study Design

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

Related Conditions & MeSH terms

• Achilles Tendon Tear

Intervention

Biological:
• PRGF
injection of 6cc into injured area of tendon
• placebo
injection of 6 cc of saline into injured area

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of symptoms / disease progress		1 year	Yes