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Sponsors and Collaborators: |
Hospital for Special Surgery, New York Musculoskeletal Transplant Foundation |
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Information provided by: | Hospital for Special Surgery, New York |
ClinicalTrials.gov Identifier: | NCT00198185 |
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.
Condition | Intervention | Phase |
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Rotator Cuff Tendon Injuries |
Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Evaluation of Cascade PRFM on Rotator Cuff Healing |
Estimated Enrollment: | 136 |
Study Start Date: | January 2005 |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew D Pearle, MD | 212 774 2333 | pearlea@hss.edu |
Contact: Cornelia Griggs, Bachelor's | 212 774 7520 | griggsc@hss.edu |
United States, New York | |
Hospital for Special Surgery | Recruiting |
New York City, New York, United States, 10021 | |
Contact: Andrew D Pearle, MD 212-774-2333 pearlea@hss.edu | |
Contact: Cornelia Griggs, Bachelor's 212-774-7520 griggsc@hss.edu | |
Sub-Investigator: Andrew D Pearle, MD |
Principal Investigator: | Russell F. Warren, MD | Hospital for Special Surgery |
Study ID Numbers: | 24087 |
Study First Received: | September 12, 2005 |
Last Updated: | January 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00198185 |
Health Authority: | United States: Institutional Review Board |
Full Thickness Tendon Defect of Rotator Cuff |
Tendon Injuries Wounds and Injuries Disorders of Environmental Origin |