Rotator Cuff Tear Clinical Trial
Official title:
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 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 patients undergoing rotator cuff repair.
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).
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