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

NCT01767740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-10-06

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear

Interventions

DEVICE

ULTRABRAID PLUS SUTURE

Rotator Cuff Repair with ULTRABRAID PLUS SUTURE

DEVICE

ULTRABRAID SUTURE

Rotator Cuff Repair with ULTRABRAID SUTURE

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Litchfield, MD, FRCSC · Fowler Kennedy Sports Medicine Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767740 on ClinicalTrials.gov