Full-thickness rotator cuff repair with bovine collagen implant may be safe, effective
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Published results showed arthroscopic double-row repair augmented with a bioinductive bovine collagen implant may yield favorable rates of radiographic retear and substantial functional recovery for full-thickness rotator cuff tears.
“Our study showed that use of a bioinductive bovine collagen implant to supplement traditional repair of full-thickness rotator cuff tears has a favorable rate of radiographic retear and a low complication rate,” Brandon D. Bushnell, MD, MBA, of the department of orthopedic surgery at the Harbin Clinic, told Healio. “Essentially, this device appears to be safe and likely effective in improving rotator cuff surgery outcomes for our patients.”
Bushnell and colleagues recorded MRI and patient-reported outcomes at baseline, 3 months, 1 year and 2 years postoperatively among 115 patients with medium (n=66) and large (n=49) full-thickness rotator cuff tears who underwent single- or double-row arthroscopic repair augmented with a bioinductive bovine collagen implant (Regeneten, Smith & Nephew).
Results showed the mean total thickness of the supraspinatus tendon increased by 12.5% for medium tears and by 17.1% for large tears between baseline and 2-year follow-up. Researchers found 11.5% of patients with medium tears and 35% of patients with large tears had a radiographic retear, which occurred before the 3-month follow-up visit in 61.9% of patients. Overall, 13.2% of patients who underwent the supplemented double-row repair technique had a radiographic retear, according to results.
For both the American Shoulder and Elbow Surgeons score and Constant-Murley score, researchers noted more than 90% of patients with both medium and large tears achieved the minimal clinically important difference. The treating surgeon identified two serious adverse events possibly related to the device or procedure, including one case of swelling or drainage and one case of intermittent pain. Results showed 7.8% of patients required reoperation of the index rotator cuff surgery.
“This study lays firm groundwork for the several randomized controlled trials that are now underway to further investigate this exciting technology,” Bushnell said. “Advanced biologics, such as this implant, will likely be the standard of care for rotator cuff surgery in the future.”
Perspective
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For our patients with rotator cuff injuries requiring surgical repair, there is a need for augmentation in situations with poor tissue quality, an unfavorable biologic environment and unmodifiable patient factors. Biologic scaffolds are one augmentation strategy that can lead to lower retear rates and greater patient satisfaction.
Brandon D. Bushnell, MD, MBA, and colleagues have previously shown a 3% retear rate with use of a resorbable, bovine, Achilles tendon scaffold for the treatment of intermediate- and high-grade partial-thickness supraspinatus tendon tears. Now the researchers evaluated the safety, efficacy and outcomes of this biologic scaffold in 115 patients with full-thickness medium-to-large rotator cuff tears at 2 years following repair. They found tendon thickness increased by 15%, a 2% complication rate, an 8% reoperation rate and more than 90% of patients achieved the minimal clinically important difference for their ASES score and Constant-Murley score. However, the retear rate was greater in patients with large tears compared with medium tears (35% vs. 12%).
The authors’ work suggests that this xenogenic biologic scaffold is safe and efficacious with low retear rates in patients with partial-thickness and full-thickness medium-sized rotator cuff tears. The implant does not impact augmentation of large tears because it is not a mechanical scaffold. A scaffold with dual functionality to optimize both biology and mechanics is needed to improve structural healing rates, function and strength in patients with large-to-massive tears.
References:
Bushnell BD, et al. JSES Int. 2020;doi:10.1016/j.jseint.2020.10.020.
Bushnell BD, et al. J Shoulder Elbow Surg. 2022;doi:10.1016/j.jse.2022.05.025.
Schlegel TF, et al. J Shoulder Elbow Surg. 2021;doi:10.1016/j.jse.2020.10.022.
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