Background: Evidence to justify the use of porcine small intestine
submucosa to augment repairs of large and massive rotator cuff tears is based
on favorable results found in studies of Achilles tendon and infraspinatus
tendon repairs in canines. The purpose of this study was to determine the
effectiveness of a small intestine submucosal patch to augment the repair of
chronic two-tendon rotator cuff tears in humans.
Methods: Thirty shoulders with a chronic two-tendon rotator cuff
tear that was completely repairable with open surgery were randomized to be
treated with either augmentation with porcine small intestine mucosa or no
augmentation. All patients completed a PENN shoulder-score questionnaire
preoperatively and at the time of the latest follow-up (at an average of
fourteen months). Magnetic resonance imaging showed that nine shoulders had a
large tear and twenty-one had a massive tear. All patients underwent a
magnetic resonance imaging scan with intra-articular gadolinium one year after
the repair to assess the status of the rotator cuff.
Results: The rotator cuff healed in four of the fifteen shoulders in
the augmentation group compared with nine of the fifteen in the control group
(p = 0.11). The median postoperative PENN total score was 83 points in the
augmentation group compared with 91 points in the control group (p = 0.07).
Healing of the defects in both groups demonstrated a strong correlation with
the patients' clinical scores. The median postoperative PENN total score was
96 points in the group with a healed repair and 81 points in the group with a
failed repair (p = 0.007). The percentage change between the preoperative and
postoperative patient satisfaction scores was 400% in the group with a healed
repair, and 50% in the group with a failed repair (p = 0.04).
Conclusions: Augmentation of the surgical repair of large and
massive chronic rotator cuff tears with porcine small intestine submucosa did
not improve the rate of tendon-healing or the clinical outcome scores. On the
basis of these data, we do not recommend using porcine small intestine
submucosa to augment repairs of massive chronic rotator cuff tears done with
the surgical and postoperative procedures described in this study.
Level of Evidence: Therapeutic Level II. See Instructions
to Authors for a complete description of levels of evidence.