- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02628457
Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?
December 10, 2015 updated by: CM Chungmu Hospital
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
209
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seoul
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Yeongdeungpo-gu, Seoul, Korea, Republic of
- Chungmu General Hopsital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mild Subgroup
patients with supraspinatus tendon retracted upto medial 1/3rd of humerus head and arthroscopic rotator cuff repair done by single row.
|
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
|
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.
|
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
|
Severe subgroup
patients with supraspinatus tendon retracted beyond glenoid and arthroscopic rotator cuff repair done by single row
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 1 week after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: sang-Hoon Lhee, MD PhD, President, CM general Hospital
- Principal Investigator: Anant kumar Singh, arthroscopy fellow, CM general Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
January 1, 2016
Study Registration Dates
First Submitted
December 3, 2015
First Submitted That Met QC Criteria
December 10, 2015
First Posted (Estimate)
December 11, 2015
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMH-2015-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Sharing of data on the website is against the policy of IRB Korea
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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