Rotator Cuff SyndromeNCT01996904
Prospective Randomized Comparative Study of Outcome of Subscapularis Tear
A study testing arthroscopic repair and arthroscopic debridement in people with Rotator Cuff Syndrome, run by CM Chungmu Hospital at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 44 to 83 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- arthroscopic repair and arthroscopic debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- arthroscopic repair, arthroscopic debridement
- Keywords
- subscapularis tear, arthroscopic tendon repair, arthroscopic tendon debridement, ASES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic repairProcedure or surgery
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.
arthroscopic debridementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic repair | Experimental | 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. Receives: Procedure: arthroscopic repair |
| arthroscopic debridement | Active comparator | 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. Receives: Procedure: arthroscopic debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES Score
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).
Measured: 24th month
Secondary outcomes (1)
Ultrasound Diagnosis
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.
Measured: every three months after the surgery until the 24th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- CM Chungmu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Hoon Lhee, CM Chungmu Hospital
- Investigators
- Sang-Hoon Lhee, MD, PhD, Principal investigator, CM Chungmu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996904
- Sponsor's protocol ID
- CMH-2013-03
- Status last verified
- Jan 2014
- First submitted
- 22 Nov 2013
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Study of 191 Subscapularis Tear: Clinical and Radiologic Outcome - Arthroscopic Repair vs Debridement
- ClinicalTrials.gov ID
- NCT01996904
- Acronym / sponsor ID
- CMH-2013-03
- Conditions
- Rotator Cuff Syndrome
- Keywords
- subscapularis tear, arthroscopic tendon repair, arthroscopic tendon debridement, ASES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- CM Chungmu HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthroscopic repair | Experimental | Procedure: arthroscopic repairLateral-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. |
| arthroscopic debridement | Active comparator | Procedure: arthroscopic debridementOpen 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. |
Who may qualify
- Ages
- 44 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 repairIf 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. | Procedure or surgery | arthroscopic repair |
| arthroscopic debridementAnterosuperior 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. | Procedure or surgery | arthroscopic debridement |
Primary outcome
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).
1 secondary outcome
Ultrasound Diagnosis
Time frame: every three months after the surgery until the 24th month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rotator Cuff Syndrome
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
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.
Sang-Hoon Lhee, MD, PhD principal investigator
CM Chungmu Hospital
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 repair and arthroscopic debridement in people with Rotator Cuff Syndrome, run by CM Chungmu 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: finished, as of the sponsor's last update on 12 Mar 2014. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Score (time frame: 24th month). 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 12 Mar 2014.