Table 3.
Overview of human studies evaluating scaffold augmentation of rotator cuff repair.
| Study | Study type | Sample size | Follow-up | Results and conclusions |
|---|---|---|---|---|
| Lenart et al.83 | Case series | n = 16 | Mean 1.5 years | PLL patch augmentation reported significant improvements in functional outcomes but had a retear rate of 62% |
| Ciampi et al.84 | Cohort study | n = 152 | Two, 12, 36 months | Polypropylene patch augmentation for RCR significantly improved function, strength, and retear rates at 36 months. |
| Proctor47 | Case series | n = 18 | Six, 12, and 42 months | PLL bioabsorbable synthetic patch successfully reinforced surgical repair of large to massive RCR at 12 (83%) and 42 (78%) months. |
| Encalada-Diaz et al.18 | Case series | n = 10 | Two and four weeks Three, six, and 12 months | PCPU patch was well tolerated with a 10% retear rate at 12 months. |
| Gupta et al.77 | Case series | n = 27 | Minimum two years | Dermal tissue matrix xenograft group demonstrated improved pain, AROM, and subjective outcomes (ASES and SF-12 scores) and US revealed intact cuff reconstruction. |
| Barber et al.82 | RCT | n = 42 | Mean 14.5 months | Acellular dermal human allograft augmentation of large (>3 cm) tears involving two tendons showed better ASES and Constant scores. MRI revealed 85% intact repair in treatment versus 40% in controls (p < 0.01). |
| Phipatanakul and Petersen79 | Case series | n = 11 | Minimum two years | Porcine SIS xenograft did not reconstitute rotator cuff tissue or improve the quality of the RCR. |
| Badhe et al.78 | Case series | n = 10 | Six weeks, three and 12 months | PDC patch demonstrated excellent pain relief with moderate improvement in AROM and strength for chronic tears. |
| Walton et al.81 | Case control | n = 19 | Three, six, and 24 months | The ROI xenograft group had persisting cuff deficits, no clinical advantage compared to the control group, and a high proportion suffered a severe inflammatory reaction. |
| Iannotti et al.80 | RCT | n = 30 | One year | Porcine SIS augmentation did not improve tendon healing or clinical outcomes for large and massive RCR compared to controls. |
AROM: active range of motion; ASES: American Shoulder and Elbow Surgeon; MRI: magnetic resonance imaging; PCPU: polycarbonate polyurethane; PDC: porcine dermal collagen; PLL: poly-L-lactide; RCR: rotator cuff repair; RCT: randomized control trial; ROI: Restore orthobiologic implant; SIS: small intestinal submucosa; US: ultrasound.