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

Phase 3WithdrawnNCT00198185

Hospital for Special Surgery, New York

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Rotator Cuff Tendon Injuries

Interventions

Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff SurgeryPROCEDURE

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital for Special Surgery

New York, New York, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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