Over 50% of rotator cuff repairs failed, with or without a biological graft

A randomized clinical trial to compare the effectiveness of rotator cuff repair with or without augmentation using porcine small intestine submucosa for patients with moderate to large rotator cuff tears: a pilot study.

These authors randomized 62 patients with moderate and large cuff tears to repair alone (control) or augmentation with SIS (Restore Orthobiologic Implant; DePuy, Warsaw, IN, USA). Primary outcome was repair failure using magnetic resonance orthography. The average tear measured 3 cm in the anteroposterior direction and 2.7 cm in the medial to lateral direction.

The repair was accomplished as either a tongue-in-groove or an onlay reattachment of the cuff tendon to bone. The free edge of the detached tendon was either reimplanted into a trough at the base of the tuberosity or held securely opposed to the bone with transosseous sutures or absorbable anchors. For patients randomized to receive the SIS augmentation, the graft was extended over the repaired rotator cuff tendon and the tuberosity to which the tendon was attached.

To evaluate the success of the repair, patients underwent standardized magnetic resonance arthrography (MRA) of the rotator cuff at 1 year postoperatively to determine whether the defect had healed and, if it had not healed completely, whether the remaining full-thickness defect had increased by >5 mm in any dimension from the immediate postoperative appearance. If such a defect was detected, the repair was classified as having failed.

At 1 year, failures occurred in 52.9% (18/34) of the SIS group and in 65.4% (17/26) in the control group. The mean difference between groups for patient-reported outcomes was not significant.

They found no evidence that augmented rotator cuff repair provides superior outcomes in patients with moderate rotator cuff tears.

Comment: This study shows the high rate (>50%) of anatomic failure of repairs of moderate to large sized cuff tears, irrespective of the use of graft augmentation

The authors did not compare the clinical outcomes of the intact vs. the failed repairs; based on other studies, however, it is likely that the clinical outcomes were largely independent of the success of the repair. 

Our approach to these tears is shown in this link.

It is of interest that the authors apparently normalized the results of the different clinical outcome scales used and that the results with the different scales are quite similar:

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Rotator cuff repair reinforcement with extracellular matrix graft - does integrity matter?

A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix.

These authors studied  61 shoulders with large repairable rotator cuff tears (3 to 5 cm). The rotator cuff tears were surgically repaired and reinforced with a extracellular matrix (ECM) xenograft. The average patient age was 56 years (range, 40-69 years). The average tear size was 3.8 cm.  Double row cuff repair was performed by minimally invasive open technique.  The graft was cut to overlap the completed repair of the rotator cuff covering the entire repair and was attached medially using a modified Mason-Allen technique.

Functional outcome scores, isometric muscle strength, and active range of motion were significantly improved compared with baseline. 

Magnetic resonance imaging at 12 months showed retorn rotator cuff repairs in 33.9% of shoulders, using the criteria of a tear of at least 1 cm, and tears in 14.5% of the shoulders using the criteria of retear >80% of the original tear size. Three patients underwent surgical revision. Complications included 1 deep infection.

Comment: While the absence of a comparison group treated without ECM does not allow determination of the value (benefit/cost) of the ECM in comparison to double row repairs performed without graft, the results are interesting in two particular regards. First the retear rates did not increase between 6 and 12 months. 

Second, the clinical outcomes showed the same amount of improvement whether or not the cuff repairs remained intact or retore as shown below.

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