Two-Arm, Single Blind, Randomized Pilot Study on the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff

The primary objective of this two-arm, randomized, single-blind pilot study is to obtain safety data on the use of the ULTRABRAID Plus Suture and to assess the preliminary effectiveness of the use of the ULTRABRAID Plus Suture in comparison to the ULTRABRAID Suture in subjects undergoing rotator cuff repair. The primary endpoint of the 6-month postoperative analysis is to assess rotator cuff integrity at 6 months, defined as the proportion of subjects with a re-tear of the rotator cuff as measured by high-resolution ultrasound.

Secondary endpoints include:

rotator cuff integrity at the other time points, as well as between arms (1, 3, 6 weeks and 3, 12 months); difference in tissue thickness and muscle atrophy using high-resolution ultrasound between baseline (preoperative) and all postoperative time points (1, 3, 6 weeks and 3, 6, 12 months); difference in tendon echogenicity and vascularity using Doppler ultrasound between baseline (preoperative) and all postoperative time points (1, 3, 6 weeks and 3, 6, 12 months); difference in Constant Shoulder Assessment score and Western Ontario Rotator Cuff (WORC) Index between baseline (preoperative) and all postoperative time points (1, 3, 6 weeks and 3, 6, 12 months); rehabilitation:

• time to active-assisted rehab exercises
• time to isometric rehab exercises
• time to discontinuation of an arm sling lab results (C-Reactive Protein [CRP], Erythrocyte Sedimentation Rate [ESR] and Butyric Acid Levels) at 1, 3, and 6 weeks postoperatively; adverse event (AE) rates (all categories).