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Subscapularis Tears in Large to Massive Rotator Cuff Tear

Primary Purpose

Massive Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
arthroscopic reapir of subscapularis tendon
arthroscopic debridement of subscapularis tendon
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Massive Rotator Cuff Tears

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. a full-thickness superoposterior rotator cuff tear larger than 5 cm or complete superoposterior rotator cuff tear identified on preoperative MRI and intra operative arthroscopic findings
  2. a follow-up MRI evaluation at 6 months after surgery, and
  3. a clinical assessment performed a minimum 2 years postoperatively.

Exclusion Criteria:

  1. small, medium, or large tears
  2. a partial-thickness tear
  3. an isolated subscapularis tear
  4. failure of subscapularis repair at the time of the index procedure
  5. previous rotator cuff surgery of the affected shoulder
  6. concomitant surgery for glenohumeral joint instability or other bony procedure
  7. substantial glenohumeral arthritis (Hamada classification grade 4) or inflammatory arthropathy of the affected shoulder.

Sites / Locations

  • Wonkwang University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

subscapularis tendon repair

subscapularis tendon debridement

Arm Description

arthroscopic reapir of subscapularis tendon

arthroscopic debredement of subscapularis tendon

Outcomes

Primary Outcome Measures

Visual analogue scale
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

Secondary Outcome Measures

The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
reliability, validity, and responsiveness

Full Information

First Posted
November 20, 2017
Last Updated
November 22, 2017
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03352180
Brief Title
Subscapularis Tears in Large to Massive Rotator Cuff Tear
Official Title
Do Concomitant Subscapularis Tears in Large to Massive Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Anticipated)
Study Completion Date
July 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Do concomitant subscapularis tears in large to massive rotator cuff tears affect postoperative functional and structural outcomes? Background and purpose: The subscarpularis tendon is essential force maintaining normal glenohumeral biomechanics. However, there are few studies which have addressed the outcomes of tears extending to the subscapularis tendon in massive rotator cuff tears. The purpose of this study was to assess the clinical and structural outcomes of arthroscopic reapair of massive rotator cuff tears involving the subscapulrais.
Detailed Description
MATRALS AND METHODS This retrospective comparative study was approved by our institutional review board. Patient Selection This study targeted patients who had undergone arthroscopic rotator cuff repair, which was performed by a single surgeon in our institution between January 2010 and January 2014. The inclusion criteria were as follows: (1) a full-thickness superoposterior rotator cuff tear larger than 5 cm(19) or complete superoposterior rotator cuff tear(24) identified on preoperative MRI and intra operative arthroscopic findings, (2) a follow-up MRI evaluation at 6 months after surgery, and (3) a clinical assessment performed a minimum 2 years postoperatively. The exclusion criteria were as follows: (1) small, medium, or large tears(21); (2) a partial-thickness tear; (3) an isolated subscapularis tear; (4) failure of subscapularis repair at the time of the index procedure; (5) previous rotator cuff surgery of the affected shoulder; (6) concomitant surgery for glenohumeral joint instability or other bony procedure; and (7) substantial glenohumeral arthritis (Hamada classification29 grade 4) or inflammatory arthropathy of the affected shoulder. Tear Classification Rotator cuff tear patterns were classified into the following 3 categories according to the tear size of the subscapularis tendon on preoperative MRI: I-massive tear, intact subscapularis tendon; S-massive tear, tear involving half or less than half of the subscapularis tendon; and L-massive tear, tear extending to more than half of the subscapularis tendon. Clinical Assessments Clinical data were recorded on the day before surgery and at final follow-up (at least 24 months postoperatively) by fellowship trainees. Four outcome measures were used in this study: VAS pain score, ASES score, Constant score, and active shoulder ROM. The ASES score involves a score summation using a 100-point system (50 points for daily function and 50 points for pain). Radiographic Evaluation A standard set of plain radiographs was obtained as follows: anteroposterior (AP) views in internal rotation and external rotation, supraspinatus outlet view, axillary view, and Rockwood view (30 caudally angled AP view). We evaluated fatty degeneration of the rotator cuff muscle preoperatively with MRI, using the 5-stage grading system27: grade 0, no fatty deposit; grade 1, some fatty streaks; grade 2, more muscle than fat; grade 3, as much muscle as fat; and grade 4, less muscle than fat. The integrity of rotator cuff repair was determined by ultrasonographic evaluation. All patients underwent a postoperative ultrasonographic examination at 4.5 months and 12 months or later after surgery. One specialized radiologist with more than 10 years of experience in musculoskeletal ultrasonography performed all follow-up examinations using an HDI 5000 system or an IU-22 system (both from Philips Healthcare). He did not receive any information on intraoperative findings and subsequent operative procedures. An ultrasonographic evaluation of the rotator cuff was performed according to the standard protocol.42 The ultrasound criteria for the diagnosis of full-thickness rotator cuff tears were as follows5,54: (1) absence of observation of the supraspinatus tendon attributable to retraction under the acromioclavicular joint; (2) localized absence or focal discontinuity of the rotator cuff with concomitant loss of the normal anterior arc of the subdeltoid bursa; (3) loss of the normal supraspinatus substance with widening of the gap between the supraspinatus and biceps tendons, including exposure of a bare area of bone and cartilage; (4) a hypoechoic or anechoic cleft extending through the entire substance of the rotator cuff; and (5) coexistence of fluid in the subacromial-subdeltoid bursa and/or presence of fluid in the sheath of the long head of the biceps tendon. Partialthickness tears were diagnosed based on the presence of a focal hypoechoic or anechoic defect in the tendon, involving either the bursal or articular surface and manifesting in 2 perpendicular planes.54

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massive Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subscapularis tendon repair
Arm Type
Active Comparator
Arm Description
arthroscopic reapir of subscapularis tendon
Arm Title
subscapularis tendon debridement
Arm Type
Active Comparator
Arm Description
arthroscopic debredement of subscapularis tendon
Intervention Type
Procedure
Intervention Name(s)
arthroscopic reapir of subscapularis tendon
Intervention Description
arthroscopic reapir of massive rotator cuff tears involving the subscapularis.
Intervention Type
Procedure
Intervention Name(s)
arthroscopic debridement of subscapularis tendon
Intervention Description
arthroscopic debridement of massive rotator cuff tears involving the subscapularis.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Description
reliability, validity, and responsiveness
Time Frame
4weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a full-thickness superoposterior rotator cuff tear larger than 5 cm or complete superoposterior rotator cuff tear identified on preoperative MRI and intra operative arthroscopic findings a follow-up MRI evaluation at 6 months after surgery, and a clinical assessment performed a minimum 2 years postoperatively. Exclusion Criteria: small, medium, or large tears a partial-thickness tear an isolated subscapularis tear failure of subscapularis repair at the time of the index procedure previous rotator cuff surgery of the affected shoulder concomitant surgery for glenohumeral joint instability or other bony procedure substantial glenohumeral arthritis (Hamada classification grade 4) or inflammatory arthropathy of the affected shoulder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Woo Kim
Phone
82-10-8648-7514
Email
serina@wonkwang.ac.kr
Facility Information:
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Jeollabuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Woo Kim
Phone
82-10-8648-7514
Email
serina@wonkwang.ac.kr

12. IPD Sharing Statement

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Subscapularis Tears in Large to Massive Rotator Cuff Tear

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