Abstract
BACKGROUND: Compare all-suture anchors to traditional anchors through clinical and radiological evaluation at pre-established end-points. MATERIALS AND METHODS: We performed a two-arms non-inferiority study on all-suture anchor (2.3 iconix™, Stryker) device with respect to traditional anchor (5.5 healix Advance™ BR, Depuy/Mitek) device under unpaired samples with size equal to 30 patients per group, all suffering from supraspinatus tendon rupture. We administrated DASH (Disabilities of the Arm, Shoulder and Hand); constant; and SST (Simple Shoulder Test) questionnaires in pre-operative, 3 ± 1 months post-intervention and 8 ± 1 months post-intervention. Questionnaires scores were the primary outcome. We also evaluated RMI at 3 and at 8 months after surgery to assess the presence of oedema or any loosening of the implant. RESULTS: All-suture anchor approach has been proven to have non-inferior performances with respect to traditional anchor approach, according to questionnaires scores at the 3-month endpoint. We observed 26 patients with oedema by MRI (18 in control group, 6 in experimental group). In the 8-month endpoint we found persistent edema in 12 patients (all treated with healix), 2 had mobilitazions (healix), 10 had partial retears (8 healix, 2 iconix) and 1 implant failure (healix). CONCLUSIONS: All suture devices have clinical and functional results comparable to traditional devices, while they tend to give fewer complications in terms of bone edema, loosening and retear rate. The effectiveness of all-suture devices should be further investigated in rotator cuff suture arthroscopic revision surgery, given the advantages they offer.