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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
Rotator Cuff Repair with ULTRABRAID PLUS SUTURE
Rotator Cuff Repair with ULTRABRAID SUTURE
Innovation Science and Medicine
Burlington, Ontario, Canada
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada
St. Josephs Hospital
London, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Rotator Cuff Integrity
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.
Time frame: 6 months post-operatively
Rotator Cuff Integrity
To assess rotator cuff integrity defined as the proportion of subjects with a re-tear of the rotator cuff as measured by high-resolution ultrasound.
Time frame: 1, 3 and 6 weeks and 3 and 12 months post-operatively
Change in post-surgery tissue thickness, rotator cuff integrity, tendon echogenicity and muscle atrophy
Compared to Baseline (preop)
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Vascularity
Compared to Baseline (preop)
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Constant Shoulder Assessment
Compared to Baseline (preop)
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Western Ontario Rotator Cuff Index
Compared to Baseline (preop)
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Rehabilitation
* Time to active-assisted rehab exercises * Time to isometric rehab exercises * Time to discontinuation of arm sling
Time frame: 3 and 6 weeks and 3, 6 and 12 months post-operatively
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Labs
Compared to Baseline (preop) Note: If levels do not return to baseline, tests will continue beyond 6 weeks
Time frame: 1, 3 and 6 weeks (optional 3, 6 and 12 months) post-operatively
Adverse Events
All AE measured and observed, from the initiation of the surgical procedure and throughout the subjects participation in the study, were recorded.
Time frame: Surgery and 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively