Rotator Cuff TearNCT02628457
Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?
An observational study of Rotator Cuff Tear, run by CM Chungmu Hospital at 1 site in South Korea.
Trial summary
There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- arthroscopic rotator cuff repair
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Jan 2016
- Phase
- Observational
- 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
Study population: 209 patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair between March 2012 and April 2015 in CM hospital
Who may be able to join
- Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.
- Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.
- Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.
Who cannot join
- Patients with preoperative MRI from outside hospital.
- Patients with isolated subscapularis tear.
- Patients with previous operation on the same shoulder joint.
- Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.
Trial locations and contacts
1 site in 1 country.
About this study
There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction
Read the detailed description
Retrospective review of 209 patients having both preoperative and immediate postoperative MRI done. Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. Patient were divided in two major group according to age that is <60 years and >60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of MRI. Postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. Change in occupation ratio was also used for comparison between 2 major groups
- Conditions
- Rotator Cuff Tear
- Being tested
- arthroscopic rotator cuff repair
- Keywords
- occupation ratio, pseudoatrophy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic rotator cuff repairProcedure or surgery
arthroscopic rotator cuff repair done in all patients to check whether, surgery itself changes the appearance of muscle atrophy in the supraspinatus in all patients irrespective of size of preoperative tendon retraction
| Study group | Role | What they receive |
|---|---|---|
| Mild Subgroup | patients with supraspinatus tendon retracted upto medial 1/3rd of humerus head and arthroscopic rotator cuff repair done by single row. Receives: Procedure: arthroscopic rotator cuff repair | |
| Moderate Subgroup | patients with supraspinatus tendon retracted between medial 1/3rd of humerus head and glenoid,and arthroscopic rotator cuff repair done by single row. Receives: Procedure: arthroscopic rotator cuff repair | |
| Severe subgroup | patients with supraspinatus tendon retracted beyond glenoid and arthroscopic rotator cuff repair done by single row Receives: Procedure: arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in supraspinatus muscle atrophy
Supraspinatus muscle atrophy was measured and evaluated according to the Thomazeau classification. Stage 1: slight atrophy occupation ratio (1.00-0.60), Stage 2: moderate atrophy occupation ratio (0.60-0.40), Stage 3: Severe atrophy occupation ratio(<0.40). Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient.Postoperative occupation ratio was compared with preoperative occupation ratio within the groups and change in occupation ratio was used for comparison between the groups.
Measured: within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- CM Chungmu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sang-Hoon Lhee, MD PhD, Study chair, President, CM general HospitalAnant kumar Singh, Principal investigator, arthroscopy fellow, CM general Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628457
- Sponsor's protocol ID
- CMH-2015-02
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Sharing of data on the website is against the policy of IRB Korea
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?
- ClinicalTrials.gov ID
- NCT02628457
- Acronym / sponsor ID
- CMH-2015-02
- Conditions
- Rotator Cuff Tear
- Keywords
- occupation ratio, pseudoatrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (actual)
- Lead sponsor
- CM Chungmu HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 11 Dec 2015 (estimated)
- 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.
There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction
Detailed description
Retrospective review of 209 patients having both preoperative and immediate postoperative MRI done. Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. Patient were divided in two major group according to age that is <60 years and >60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of MRI. Postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. Change in occupation ratio was also used for comparison between 2 major groups
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Subgroup | – | Procedure: arthroscopic rotator cuff repairpatients with supraspinatus tendon retracted upto medial 1/3rd of humerus head and arthroscopic rotator cuff repair done by single row. |
| Moderate Subgroup | – | Procedure: arthroscopic rotator cuff repairpatients with supraspinatus tendon retracted between medial 1/3rd of humerus head and glenoid,and arthroscopic rotator cuff repair done by single row. |
| Severe subgroup | – | Procedure: arthroscopic rotator cuff repairpatients with supraspinatus tendon retracted beyond glenoid and arthroscopic rotator cuff repair done by single row |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 209 patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair between March 2012 and April 2015 in CM hospital
Key inclusion criteria (3 listed)
- Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.
- Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.
- Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.
Key exclusion criteria (4 listed)
- Patients with preoperative MRI from outside hospital.
- Patients with isolated subscapularis tear.
- Patients with previous operation on the same shoulder joint.
- Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.
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 rotator cuff repairarthroscopic rotator cuff repair done in all patients to check whether, surgery itself changes the appearance of muscle atrophy in the supraspinatus in all patients irrespective of size of preoperative tendon retraction | Procedure or surgery | Mild Subgroup, Moderate Subgroup, Severe subgroup |
Primary outcome
change in supraspinatus muscle atrophy
Time frame: within 1 week after surgery
Supraspinatus muscle atrophy was measured and evaluated according to the Thomazeau classification. Stage 1: slight atrophy occupation ratio (1.00-0.60), Stage 2: moderate atrophy occupation ratio (0.60-0.40), Stage 3: Severe atrophy occupation ratio(<0.40). Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient.Postoperative occupation ratio was compared with preoperative occupation ratio within the groups and change in occupation ratio was used for comparison between the groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Individual participant dataSharing planned: No. Sharing of data on the website is against the policy of IRB Korea
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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.
sang-Hoon Lhee, MD PhD study chair
President, CM general Hospital
Anant kumar Singh principal investigator
arthroscopy fellow, CM general Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, 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 4 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 11 Dec 2015. 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?
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?
change in supraspinatus muscle atrophy (time frame: within 1 week after surgery). 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 11 Dec 2015.