Open Architecture, Biocomposite Regenesorb Anchors Demonstrate Favorable Healing and Osseous Integration at Two years.

Abstract Introduction Commercially available suture anchors for rotator cuff repairs can differ significantly in architecture and material. Clinical data on their osseous integration and its effect on patient reported outcomes is scarce. Preclinical investigations indicated a higher rate of osseous integration for the open architecture design of the Healicoil Regenesorb anchor than the closed threaded design of the Twinfix (Smith and Nephew, Memphis, TN , USA). The purpose of this study was to investigate these two anchors with different architecture and material to determine their effect on osseous integration and clinical outcomes after rotator cuff repair. Methods A prospective randomized control trial was performed from 2014 to 2019. Sixty-four patients (39 females, 25 males) with an average age of 58.7 years who underwent arthroscopic rotator cuff repair by one of four board-certified, fellowship-trained surgeons were randomized to receive Healicoil Regenesorb (PLGA/s-TCP/Calcium Sulfate) or Twinfix Ultra HA (PLLA/HA) anchors. Thirty-two patients had Healicoil anchors implanted, and 32 patients had Twinfix anchors implanted. Of the 64 patients, 51 returned at 24 months for CT examination (25 Twinfix and 26 Healicoil) to determine osteointegration of the anchors. Patient-reported outcomes, including PENN, WORC, VAS, EQ5D, SANE, GRoC, were collected at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Ultrasound was used to assess rotator cuff integrity after 6 months. Two board certified, fellowship trained orthopedic surgeons, blinded to the type of anchors, analyzed the CT scans to assess the anchor osteointegration at 24 months using a previously published grading scale. Results There were no differences in demographics, preoperative outcomes, or baseline characteristics such as tear size, number of anchors, Goutallier classification, or smoking status between groups. There was no difference in osseous integration between the two anchors at 24 months (P=0.117). Eight patients had rotator cuff re-tears, of which two patients had Twinfix anchors and six patients had Healicoil anchors (p=0.18). There were no statistically significant differences in patient reported outcomes or complications between groups. The two-year PENN scores were 89 with the Twinfix and 88 with Healicoil anchors (p=0.55). Conclusion Despite differences in material and anchor architecture, the rate of healing and patient reported outcomes were similar between the Twinfix and Healicoil anchor groups. The rate of osteointegration was the same at two years.