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Clinical Trial
. 2011 Jul;20(5):788-94.
doi: 10.1016/j.jse.2010.08.013. Epub 2010 Nov 24.

Rotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at 12 months' follow-up

Ivan Encalada-Diaz  1 , Brian J Cole, John D Macgillivray, Michell Ruiz-Suarez, James S Kercher, Nicole A Friel, Fernando Valero-Gonzalez
Affiliations
Clinical Trial

Rotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at 12 months' follow-up

Ivan Encalada-Diaz et al. J Shoulder Elbow Surg. 2011 Jul.

Abstract

Background: Preventing anatomic failure after rotator cuff repair (RCR) remains a challenge. Augmentation with a surgical mesh may permanently reinforce the repair and decrease failure rates. The purpose of this study is to assess the postoperative outcomes of open RCR augmented with a novel reticulated polycarbonate polyurethane patch.

Materials and methods: Ten patients with supraspinatus tendon tears underwent open RCR augmented with a polycarbonate polyurethane patch secured in a 6-point fixation construct placed over the repaired tendon. Patients were evaluated with preoperative and postoperative outcome measures, including the Simple Shoulder Test, visual analog pain scale, American Shoulder and Elbow Surgeons shoulder score, Cumulative Activities of Daily Living score, and University of California, Los Angeles shoulder scale, as well as range of motion. Postoperative magnetic resonance imaging was used to evaluate repair status.

Results: Patients showed significant improvements in visual analog pain scale, Simple Shoulder Test, and American Shoulder and Elbow Surgeons shoulder scores at both 6 and 12 months postoperatively (P < .05 and P < .01, respectively). The University of California, Los Angeles postoperative score was good to excellent in 7 patients at 6 months and in 8 patients at 12 months. Range of motion in forward flexion, abduction, internal rotation, and external rotation was significantly improved at both 6 and 12 months postoperatively (P < .05 and P < .01, respectively). Magnetic resonance imaging at 12 months showed healing in 90%; one patient had a definitive persistent tear. We found no adverse events associated with the patch, including the absence of fibrosis, mechanical symptoms, or visible subacromial adhesions.

Discussion: The polycarbonate polyurethane patch was designed to support tissue in growth and enhance healing as shown by preclinical animal studies. Clinically, the patch is well tolerated and shows promising efficacy, with a 10% retear rate at the 12-month time point.

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Figures

Figure 1
Figure 1
A and B, Intraoperative photographs showing 6-point suture repair configuration.
Figure 2
Figure 2
ROM. Forward flexion, abduction, and external rotation in degrees. Internal rotation values correspond to the level of internal rotation: dorsum of hand to interscapular region (T7) or higher (10), dorsum of hand to twelfth dorsal vertebrae (8), dorsum of hand to waist (L3) (6), dorsum of hand to lumbosacral junction (4), dorsum of hand to buttock (2), and dorsum of hand to lateral thigh or less (0). All 4 motions showed significant improvement from preoperatively to 6 months as well as preoperatively to 12 months (P < .05).
Figure 3
Figure 3
Postoperative MRI scan showing intact rotator cuff augmented with patch.
Figure 4
Figure 4
MRI scan at 12 months postoperatively showing retear of supraspinatus tendon.
See this image and copyright information in PMC

References

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