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Massive Rotator Cuff TearsNCT03352180

Subscapularis Tears in Large to Massive Rotator Cuff Tear

A study testing arthroscopic reapir of subscapularis tendon and arthroscopic debridement of subscapularis tendon in people with Massive Rotator Cuff Tears, run by Wonkwang University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Massive Rotator Cuff Tears
What is being tested?
arthroscopic reapir of subscapularis tendon and arthroscopic debridement of subscapularis tendon
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSouth Korea
Study dates
21 Nov 2017to 11 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting
  • Wonkwang University Hospital

    Iksan, Jeollabuk-do

    Jeong Woo Kim, 82-10-8648-7514, serina@wonkwang.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Do Concomitant Subscapularis Tears in Large to Massive Rotator Cuff Tears

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.

Read the 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

Being tested
arthroscopic reapir of subscapularis tendon, arthroscopic debridement of subscapularis tendon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arthroscopic reapir of subscapularis tendonProcedure or surgery

    arthroscopic reapir of massive rotator cuff tears involving the subscapularis.

  • arthroscopic debridement of subscapularis tendonProcedure or surgery

    arthroscopic debridement of massive rotator cuff tears involving the subscapularis.

Study groups in NCT03352180
Study groupRoleWhat they receive
subscapularis tendon repairActive comparatorarthroscopic reapir of subscapularis tendon
Receives: Procedure: arthroscopic reapir of subscapularis tendon
subscapularis tendon debridementActive comparatorarthroscopic debredement of subscapularis tendon
Receives: Procedure: arthroscopic debridement of subscapularis tendon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4weeks

Secondary outcomes (1)
  1. The American Shoulder and Elbow Surgeons Shoulder Score (ASES)

    reliability, validity, and responsiveness

    Measured: 4weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2017
  2. Study start21 Nov 2017
  3. Primary completion11 Jul 2018 (estimated)
  4. Study completion11 Jul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352180
Sponsor's protocol ID
201608-HR091
Status last verified
Nov 2017
First submitted
20 Nov 2017
Last updated
24 Nov 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing arthroscopic reapir of subscapularis tendon and arthroscopic debridement of subscapularis tendon in people with Massive Rotator Cuff Tears, run by Wonkwang University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeong Woo Kim (82-10-8648-7514, serina@wonkwang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale (time frame: 4weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.

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