Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00726245
First received: July 29, 2008
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF


Condition Intervention Phase
Muscle Tear
Biological: PRGF
Biological: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for Acute Muscle 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 ]

Estimated Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PRGF
Biological: PRGF
3-6mg IM (to area of muscle tear)
Placebo Comparator: 2
physiological saline
Biological: Placebo
3cc IM of physiological saline

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • US diagnosed muscle tear
  • age 15-40 years old

Exclusion Criteria:

  • pregnancy
  • mental or physical disabilities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726245

Locations
Israel
Meir Medicak Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00726245     History of Changes
Other Study ID Numbers: 3000
Study First Received: July 29, 2008
Last Updated: July 10, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

ClinicalTrials.gov processed this record on July 29, 2014