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

October 4, 2017 updated by: Smith & Nephew, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7R 4C7
        • Innovation Science and Medicine
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic
      • London, Ontario, Canada, N6A 4L6
        • St. Josephs Hospital
      • Toronto, Ontario, Canada, M5C 1R6
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Subjects must meet ALL of the following criteria):

  • Male or female, aged 18 to 70 years at the time of surgery
  • Willing and able to give voluntary informed consent to participate in this investigation
  • Small (<1cm), Medium (1-3cm) or large (>3-5cm) tear of the supraspinatus tendon, which may or may not include the infraspinatus tendon of the rotator cuff. Tear size will be based on area of longest dimension as evidenced by clinical examination and diagnostic imaging prior to surgery, with the definitive measurement confirmed at surgery
  • Tear requires repair within two years of initial diagnosis
  • Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity)
  • Willing and able, in the opinion of the Investigator, to cooperate with study procedures, and willing to return to study site for physical therapy and all post-operative study visits

Exclusion Criteria (Subjects must not meet ANY of the following criteria):

  • Tears involving tendons other than the supraspinatus and infraspinatus
  • Partial thickness tears of the rotator cuff (tear must be full thickness)
  • Evidence of acute trauma including fracture or dislocation of the shoulder joint
  • Chronic retraction
  • Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint
  • Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
  • Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date
  • Evidence of osteomalacia or other metabolic bone disorder(s) which may impair bone or soft tissue function
  • Evidence of other significant shoulder pathology including (Type II-IV lesion, Bankart lesion, Hill Sachs lesion)
  • Patient has grade 4 changes to articular cartilage in operative shoulder
  • Inflammatory arthropathies
  • Significant muscle paralysis of the shoulder girdle.
  • Painful pathologies of the cervical spine
  • Comminuted bone surface, which would compromise secure anchor fixation.
  • Subject has a known sensitivity to implant materials, including sodium butyrate.
  • Non-surgical rotator cuff associated treatment, such as corticosteroid injection, within one (1) month prior to scheduled surgery date
  • Participating in another investigational trial or ongoing study that would interfere with the assessment of the primary and secondary outcomes
  • Female patient who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
  • Currently known to abuse drugs or alcohol which could affect follow-up care or treatment outcomes
  • Current smoker
  • Major psychiatric illness, developmental handicap or inability to read and understand the English language
  • Major medical illness that would preclude undergoing surgery
  • Known to be involved in any active injury litigation claims relating to the study shoulder
  • Unwilling or unable to be assessed according to study protocol for one year following surgery
  • Patient requires a concomitant SLAP repair procedure in operative shoulder
  • Surgeon plans to use transosseous sutures in the study procedure
  • Surgeon plans to use a Platelet Rich Plasma product or another therapy intended to augment healing of the rotator cuff in the study procedure
  • Protocol specified surgical technique cannot be followed for this subject
  • Rotator cuff repair will be done via open (as opposed to arthroscopic) procedure
  • Any other reason (in the judgment of the investigator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ULTRABRAID PLUS SUTURE
ULTRABRAID Plus Suture manufactured by Smith & Nephew used in subjects undergoing rotator cuff repair.
Device: ULTRABRAID PLUS SUTURE
Rotator Cuff Repair with ULTRABRAID PLUS SUTURE
ACTIVE_COMPARATOR: ULTRABRAID SUTURE
ULTRABRAID Suture is a marketed suture manufactured by Smith & Nephew used in subjects undergoing rotator cuff repair.
Device: ULTRABRAID SUTURE
Rotator Cuff Repair with ULTRABRAID SUTURE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rotator Cuff Integrity
Time Frame: 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.
6 months post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rotator Cuff Integrity
Time Frame: 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.
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
Time Frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Compared to Baseline (preop)
1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Vascularity
Time Frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Compared to Baseline (preop)
1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Constant Shoulder Assessment
Time Frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Compared to Baseline (preop)
1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Change in Western Ontario Rotator Cuff Index
Time Frame: 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Compared to Baseline (preop)
1, 3 and 6 weeks and 3, 6 and 12 months post-operatively
Rehabilitation
Time Frame: 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
3 and 6 weeks and 3, 6 and 12 months post-operatively
Labs
Time Frame: 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
1, 3 and 6 weeks (optional 3, 6 and 12 months) post-operatively
Adverse Events
Time Frame: 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.
Surgery and 1, 3 and 6 weeks and 3, 6 and 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Litchfield, MD, FRCSC, Fowler Kennedy Sports Medicine Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15001105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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