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

Hospital for Special Surgery (HSS)

Status and phase

Withdrawn

Phase 3

Conditions

Tendon Injuries

Rotator Cuff

Treatments

Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00198185

24087

Details and patient eligibility

About

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.

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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