Research

Rotator Cuff Repair: A Prospective Randomized Trial Evaluating Two Commonly Performed Techniques

IRB Number: 11035

Institutional Review Board, Hospital for Special Surgery

May 11, 2011

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Frank A. Cordasco, M.D.

Co-Investigators

Hollis G. Potter, M.D.
Demetris Delos, M.D.
Lori Asaro, P.A.
Joseph Nguyen
Heather Kawalick
Brian Krichevsky
Gregory Mahony

Summary

 The study will enroll 66 patients
 Two (2) year enrollment period
 Follow-up of one (1) year with post-op MRI funded by study

Inclusion/Exclusion Criteria

Inclusion Criteria:

 Ages 45-55
 MRI one or two tendon rotator cuff tears (isolated supraspinatus or supraspinatus and infraspinatus)

Exclusion Criteria:

 Previous shoulder surgery
 Prior shoulder fracture or infection
 Subscapularis tears
 Massive rotator cuff tears (i.e. 3 or 4 tendon tears)
 Significant fatty infiltration of the rotator cuff muscles

Contact Information

Frank A. Cordasco, M.D.
cordascof@hss.edu
212.774.2605

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