Prospective Randomized Comparative Study of Outcome of Subscapularis Tear

January 24, 2014 updated by: Sang-Hoon Lhee, CM Chungmu Hospital

A Prospective Randomized Comparative Study of 191 Subscapularis Tear: Clinical and Radiologic Outcome - Arthroscopic Repair vs Debridement

The purpose of this study was to report actual percentage of subscapularis tear in concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and investigate the amount of contribution of subscapularis repair as to the outcome of whole rotator cuff repair in terms of its clinical and radiologic aspects.

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

Prospective randomized controlled study was designed to evaluate subscapularis repair in anterosuperior rotator cuff tear compared with debridement of the subscapularis tear. After identification of the subscapularis tear arthroscopically, final eligibility of participants for the study was established on the basis of intra-operative arthroscopic inspection of the subscapularis using 70 degrees arthroscope. Once eligibility was confirmed, patients were randomized to one of two arthroscopic methods; repair (group A) or debridement (group B) of the subscapularis tear. The treatment allocations were decided through an interphone by "Research Coordinator". Block randomization was performed and no stratification was performed. Random Sequence Generator (Random.org) was used for the randomization process by given number whose digit was residue of modulo 2 (0 - group A, 1 - group B). Sequence Boundaries was 1 (smallest value) to 300 (largest value) based on the number calculated from power analysis. After randomization, patients underwent arthroscopic repair or debridement of the subscapularis tear. Size of the rotator cuff tear was also determined by the arthroscopic finding (small-to-medium, medium-to-large, large-to-massive). When full-thickness tear was confined to supraspinatus, the tear was called small-to-medium size tear. Medium-to-Large size tear was defined as complete full-thickness supraspinatus tear combined with incomplete full-thickness infraspinatus tear. Large-to-massive tear consisted of complete full-thickness tear of supraspinatus and infraspinatus or complete full-thickness tear of supraspinatus and subscapularis or complete 3-tendon tears. Postoperatively, rehabilitation was identical for both groups and consisted of sling immobilization for six weeks. Pulley exercises were performed during this time period. After six weeks from the surgery, active-assisted exercise including stick exercise to achieve full range of motion was performed. After 9 weeks from the surgery, Theraband exercise was initiated to strengthen repaired rotator cuff muscles. All patients underwent ultrasound at 24 months follow-up to evaluate integrity of supraspinatus tendon. The evaluation of integrity of supraspinatus tendon was performed and compared between two groups to evaluate the contribution of the subscapularis tendon to rotator cuff integrity. Re-tear of the supraspinatus was carefully evaluated through ultrasound by musculoskeletal radiologists who were experienced in ultrasound-diagnosis of shoulder more than 10 years.

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.
191

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

  • Korea, Republic of
    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-034
        • CM Chungmu 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

44 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full-thickness supraspinatus tear confirmed by preoperative MRI
  • Willingness to be enrolled into the study and understanding the whole design of the study
  • Patients who is undergoing arthroscopic surgery for rotator cuff repair

Exclusion Criteria:

  • An irreparable massive rotator cuff tear which shows Stage-3 or 4 fatty infiltration inside the muscle of supraspinatus and subscapularis by MRI
  • Cuff tear arthropathy
  • Osteoarthritis with joint space narrowing or any joint spur identified in simple radiographs
  • A Workers' compensation claim
  • Major trauma or rotator cuff tear after shoulder dislocation
  • Previous surgery or fracture on ipsilateral extremity
  • Intact subscapularis tendon identified during arthroscopic surgery with 70 degrees arthroscope

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: Double

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: arthroscopic repair
Lateral-anterosuperior portal ("Miracle Portal") was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.
Procedure: arthroscopic repair
If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures.
Active Comparator: arthroscopic debridement
Open and arthroscopic cuff debridement procedures have been described in the literatures for management of massive rotator cuff tears; these generally result in decreased pain and overall improvement in patient's function.
Procedure: arthroscopic debridement
Anterosuperior portal was made initially for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was performed.The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.

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
ASES Score
Time Frame: 24th month
The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).
24th month

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
Ultrasound Diagnosis
Time Frame: every three months after the surgery until the 24th month
US is a diagnostic imaging technique used to visualise deep structures of the body by recording the echoes of pulsed ultrasonic waves directed into the tissues and reflected by tissue planes to the transducer. These echoes are converted into 'pictures' of the tissues under examination. It consists of a non-invasive examination that has practically no adverse effects and allows dynamic visualisation of the tendons during movement of the shoulder.
every three months after the surgery until the 24th month

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.
CM Chungmu Hospital

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: Sang-Hoon Lhee, MD, PhD, CM Chungmu Hospital

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.
March 1, 2009

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.
October 1, 2010

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.
October 1, 2010

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).
November 22, 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.
November 22, 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.
November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
March 12, 2014

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.
January 24, 2014

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.
January 1, 2014

More Information

Terms related to this study

Keywords

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.
  • CMH-2013-03

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings