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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00731068
First received: August 5, 2008
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.


Condition Intervention Phase
Achilles Tendon Tear
Biological: PRGF
Biological: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • improvement of symptoms / disease progress [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PRGF
Biological: PRGF
injection of 6cc into injured area of tendon
Other Name: platelet-derived preparation rich in growth factors
Placebo Comparator: 2 Biological: placebo
injection of 6 cc of saline into injured area
Other Name: saline 0.9% nacl

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731068

Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Omer Mei Dan, Dr Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00731068     History of Changes
Other Study ID Numbers: 2000, MeirMc07om0090CTIL
Study First Received: August 5, 2008
Last Updated: October 23, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:
Achilles tendon

ClinicalTrials.gov processed this record on April 17, 2014