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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   Information provided by Hospital for Special Surgery, New York
First Received: September 12, 2005   Last Updated: January 11, 2006   History of Changes

September 12, 2005
January 11, 2006
January 2005
 
  • 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
  • L'Insalata: Preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively.
  • ASES Patient Survey: Preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively.
Complete list of historical versions of study NCT00198185 on ClinicalTrials.gov Archive Site
  • 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
  • Ultrasound (Power Doppler Imaging): 6 weeks, 3 months post-op
  • Manual Muscle Testing Using a Dynanometer: Pre-op, 3 months post-op, 6 months post-op
  • ASES Physician Survey: Pre-op, 3 months post-op, 12 months post op.
 
Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing
The Evaluation of Cascade PRFM on Rotator Cuff Healing

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study
  • Rotator Cuff
  • Tendon Injuries
Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
136
 
 

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.
Both
45 Years and older
Yes
Contact: Andrew D Pearle, MD 212 774 2333 pearlea@hss.edu
Contact: Cornelia Griggs, Bachelor's 212 774 7520 griggsc@hss.edu
United States
 
NCT00198185
 
24087
Hospital for Special Surgery, New York
Musculoskeletal Transplant Foundation
Principal Investigator: Russell F. Warren, MD Hospital for Special Surgery
Hospital for Special Surgery, New York
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP