Iannotti, J Bone Joint Surg Am 2006 - Porcine Small Intestine Submucosa Augmentation of Surgical Repair of Chronic Two-Tendon Rotator Cuff Tears

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Porcine Small Intestine Submucosa Augmentation of Surgical Repair of Chronic Two-Tendon Rotator Cuff Tears

Iannotti, Brems, et al.·J Bone Joint Surg Am·2006·460 citations·RCT

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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

30 shoulders with a chronic 2-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 14 months).
Magnetic resonance imaging showed that 9 shoulders had a large tear and 20–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 4 of the 15 shoulders in the augmentation group compared with 9 of the 15 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.

Copyright remains with the authors and publisher.

Porcine Small Intestine Submucosa Augmentation of Surgical Repair of Chronic Two-Tendon Rotator Cuff Tears

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Porcine Small Intestine Submucosa Augmentation of Surgical Repair of Chronic Two-Tendon Rotator Cuff Tears

Iannotti, Brems, et al.·J Bone Joint Surg Am·2006·460 citations·RCT

|

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

30 shoulders with a chronic 2-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 14 months).
Magnetic resonance imaging showed that 9 shoulders had a large tear and 20–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 4 of the 15 shoulders in the augmentation group compared with 9 of the 15 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.

Copyright remains with the authors and publisher.

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