Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Device: ULTRABRAID SUTURE; Device: ULTRABRAID PLUS SUTURE

• Registration Number: NCT01767740
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Study Start: 2013-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ULTRABRAID SUTURE	ULTRABRAID SUTURE	ULTRABRAID Suture is a marketed suture manufactured by Smith \& Nephew used in subjects undergoing rotator cuff repair.
ULTRABRAID PLUS SUTURE	ULTRABRAID PLUS SUTURE	ULTRABRAID Plus Suture manufactured by Smith \& Nephew used in subjects undergoing rotator cuff repair.

Primary Outcome Measures

Name	Time	Method
Rotator Cuff Integrity	6 months post-operatively	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 Outcome Measures

Name	Time	Method
Change in post-surgery tissue thickness, rotator cuff integrity, tendon echogenicity and muscle atrophy	1, 3 and 6 weeks and 3, 6 and 12 months post-operatively	Compared to Baseline (preop)
Rotator Cuff Integrity	1, 3 and 6 weeks and 3 and 12 months post-operatively	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.
Labs	1, 3 and 6 weeks (optional 3, 6 and 12 months) post-operatively	Compared to Baseline (preop) Note: If levels do not return to baseline, tests will continue beyond 6 weeks
Rehabilitation	3 and 6 weeks and 3, 6 and 12 months post-operatively	* Time to active-assisted rehab exercises; * Time to isometric rehab exercises; * Time to discontinuation of arm sling
Adverse Events	Surgery and 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively	All AE measured and observed, from the initiation of the surgical procedure and throughout the subjects participation in the study, were recorded.
Change in Western Ontario Rotator Cuff Index	1, 3 and 6 weeks and 3, 6 and 12 months post-operatively	Compared to Baseline (preop)
Change in Vascularity	1, 3 and 6 weeks and 3, 6 and 12 months post-operatively	Compared to Baseline (preop)
Change in Constant Shoulder Assessment	1, 3 and 6 weeks and 3, 6 and 12 months post-operatively	Compared to Baseline (preop)

Trial Locations

Locations (4)

Innovation Science and Medicine; 🇨🇦 Burlington, Ontario, Canada

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

Fowler Kennedy Sport Medicine Clinic; 🇨🇦 London, Ontario, Canada

St. Josephs Hospital; 🇨🇦 London, Ontario, Canada