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Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing

This study is currently recruiting participants.
Study NCT00198185.   Last updated on January 11, 2006.   Information provided by Hospital for Special Surgery, New York

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Descriptive Information Fields
Brief Title  Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing
Official Title  The Evaluation of Cascade PRFM on Rotator Cuff Healing
Brief Summary

Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%.

The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
Secondary Outcome Measure  Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively
Condition  Rotator Cuff
Tendon Injuries
Intervention  Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
MEDLINE PMIDs 11550856,   11694920,   9486332,   3941132,   11830806,   1874784,   10724223,   8020233,   12351325,   12696985,   8550839,   15022816,   15150033,   15150032,   8166903,   11813662
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  136
Start Date  January 2005
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology.
  • Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair.

Exclusion Criteria:

  • Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.
Gender Both
Ages 45 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Andrew D Pearle, MD     212 774 2333     pearlea@hss.edu    
Contact: Cornelia Griggs, Bachelor's     212 774 7520     griggsc@hss.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00198185
Organization ID 24087
Secondary IDs ††
Study Sponsor  Hospital for Special Surgery, New York
Collaborators †† Musculoskeletal Transplant Foundation
Investigators 
Principal Investigator:     Russell F. Warren, MD     Hospital for Special Surgery    
Information Provided By Hospital for Special Surgery, New York
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date January 11, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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