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.
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
- Recruiting
Wonkwang University Hospital
Iksan, Jeollabuk-do
Jeong Woo Kim, 82-10-8648-7514, serina@wonkwang.ac.kr
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
- Conditions
- Massive Rotator Cuff Tears
- 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 group | Role | What they receive |
|---|---|---|
| subscapularis tendon repair | Active comparator | arthroscopic reapir of subscapularis tendon Receives: Procedure: arthroscopic reapir of subscapularis tendon |
| subscapularis tendon debridement | Active comparator | arthroscopic 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.
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)
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.
- First posted24 Nov 2017
- Study start21 Nov 2017
- Primary completion11 Jul 2018 (estimated)
- Study completion11 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Woo Kim, Wonkwang University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Concomitant Subscapularis Tears in Large to Massive Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03352180
- Acronym / sponsor ID
- 201608-HR091
- Conditions
- Massive Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 11 Jul 2018 (estimated)
- Study completion
- 11 Jul 2019 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subscapularis tendon repair | Active comparator | Procedure: arthroscopic reapir of subscapularis tendonarthroscopic reapir of subscapularis tendon |
| subscapularis tendon debridement | Active comparator | Procedure: arthroscopic debridement of subscapularis tendonarthroscopic debredement of subscapularis tendon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic reapir of subscapularis tendonarthroscopic reapir of massive rotator cuff tears involving the subscapularis. | Procedure or surgery | subscapularis tendon repair |
| arthroscopic debridement of subscapularis tendonarthroscopic debridement of massive rotator cuff tears involving the subscapularis. | Procedure or surgery | subscapularis tendon debridement |
Primary outcome
Visual analogue scale
Time frame: 4weeks
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.
1 secondary outcome
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.