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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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.