TABLE 1.
Clinical Studies Investigating Scaffolds Used for Augmentation of Rotator Cuff Repairsa
| Type of Scaffold | Study | Level of Evidence | Tear Size | Exclusion of Tears With Fatty Infiltration | Sample Size | Follow-up Period (Range) | Failure Rate on USS/MRI | Functional Outcome | Adverse Events |
|---|---|---|---|---|---|---|---|---|---|
| Porcine small intestinal mucosa | Iannotti et al27 | 2 (prospective RCT) | Large and massive (≥4 cm) | No | CG: 15 AG: 15 | 14 mo (12-26.5 mo) | CG: 6/15 AG: 11/15 | No difference between groups using PENN | AG: 3/15 postoperative inflammatory reaction |
| Phipatanakul and Petersen42 | 4 (case series) | Massive tears (≥5 cm) | No | 11 | 26 mo (14-38 mo) | 5/9 | Significant improvement in UCLA and ASES scores | 3/11 postoperative inflammatory reaction | |
| Walton et al56 | 3 (case-control) | — | No | CG: 16 AG: 15 | 24 mo | CG: 7/12 AG: 6/10 | AG had significantly less lift-off strength, and significantly less strength in internal rotation and adduction than the CG | AG: 4/10 postoperative inflammatory reaction | |
| Porcine dermal collagen patch | Badhe et al3 | 4 (case series) | Tears ≥5 cm | No | 10 | 4.5 y (3-5 y) | 2/10 | Significant improvement in Constant score | None |
| Porcine dermal extracellular tissue matrix | Gupta et al24 | 4 (case series) | Full-thickness supraspinatus tear with ≥5 cm retraction/full-thickness 2-tendon tear | Yes | 26 | 32 mo (24-40 mo) | 1/26 | Significant improvement in ASES and SF-12 scores | None |
| Acellular dermal matrix | Bond et al9 | 4 (case series) | Tears that were ≥5 cm or involved 2 tendons, or both | No | 16 | 26.7 mo (12-38 mo) | 3/16 | Significant improvement in UCLA and Constant scores | None |
| Barber et al5 | 2 (prospective RCT) | Large (≥3 cm) 2-tendon tears | No | CG: 20 AG: 22 | 24 mo (12-38 mo) | CG: 9/15 AG: 3/20 | AG exhibited significantly better ASES and Constant scores | None | |
| Gupta et al23 | 4 (case series) | Full-thickness rotator cuff tear with >5 cm retraction | Yes | 24 | 36 mo (29-42 mo) | 1/24 | Significant improvement in ASES and SF-12 scores | None | |
| Absorbable collagen and nonabsorbable polypropylene patch | Ciampi et al13 | 3 (cohort study) | Full-thickness, 2-tendon tear with <2 cm postoperative residual retraction | Advanced fatty infiltration excluded | Collagen: 49 Polypropylene: 52 CG: 51 | 36 mo | Collagen: 25/49 Polypropylene: 9/52 CG: 21/51 | UCLA scores at 36 months were significantly higher for the polypropylene group. Elevation and strength of the polypropylene group were significantly higher than those of the other groups | None |
| Absorbable poly-L-lactic acid | Proctor43 | 4 (case series) | Large to massive (2 or 3 tendons) tears with ≥3 cm retraction | No | 18 | 42 mo (35-47 mo) | 3/18 | Significant improvement in ASES score | None |
| Lenart et al33 | 4 (case series) | Massive tear (complete detachment of at least 2 tendons) | No | 16 | 1.5 y (1.2-1.7 y) | 8/13 | Significant improvement in ASES and PENN scores | None |
aAG, augmentation group; ASES, American Shoulder and Elbow Surgeons; CG, control group; MRI, magnetic resonance imaging; PENN, PENN Shoulder Score; RCT, randomized controlled trial; USS, ultrasound scan; SF-12, Short Form–12; UCLA, University of California, Los Angeles.