Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?

July 24, 2018 updated by: Taipei Veterans General Hospital, Taiwan

Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?

There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.

Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.

If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.

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.

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.
80

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

  • Taiwan
      • Taipei, Taiwan, 11217
        • Hsiao-Li

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
  • patient was willing and able to provide scores for the study

Exclusion Criteria:

  • irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
  • glenohumeral or acromioclavicular joint osteoarthritis
  • stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
  • revision surgery
  • patients with bacteremia, a systemic infection, or an infection at the surgical site
  • patients who previously attempted or failed a treatment program

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 Assignment
  • Masking: Triple

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: Suture-spanning augmentation of single-row repair
Procedure: Suture-bridge augmentation of single-row repair
Active Comparator: single-row repair
Procedure: Suture-bridge augmentation of single-row repair

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
Retear rate
Time Frame: 6 months
Using MR imaging to determine the presence or absence of rotator cuff retears
6 months

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
Visual Analog Score (VAS)
Time Frame: 2 years
Record the VAS (pain level from 0-10) by the questionnaire, pre-op/post-op 2-year
2 years
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: 2 years
Record the ASES score by the questionnaire, focus on joint pain, instability, and activities of daily living, pre-op/post-op 2year
2 years
University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
Time Frame: 2 years
Record the UCLA shoulder score by the questionnaire, focusing on five sub-scales made up of: active forward elevation and strength (physician reported), pain, satisfaction, and function (patient reported), pre-op/post-op 2-year
2 years
Shoulder constant score
Time Frame: 2 years
Record the shoulder constant score by the questionnaire, focusing on ROM, functional assessment, strength measure, pre-op/post-op 2-year
2 years

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.
Taipei Veterans General Hospital, Taiwan

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.
  • Study Director: Hsiao-Li Ma, MD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
May 1, 2015

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.
April 30, 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.
June 30, 2018

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).
July 17, 2018

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.
July 24, 2018

First Posted (Actual)

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.
August 1, 2018

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.
August 1, 2018

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.
July 24, 2018

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.
July 1, 2018

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.
  • 104-2314-B-075-082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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