None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : After arthroscopic rotator cuff repair, patients are allocated randomly into two group(intervention group and control group). In intervention group, mediclore 5cc a
Sponsors
Seoul National University Bundang Hospital
Kyungpook National University Hospital
Wonkwang University Hospital
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects should be suitable consistent with all of these criteria. 1) Age>= 20, age=<80 2) Patient who underwent intraoperative conversion to complete tear from High grade partial thickness rotator cuff tear 3) Small(<1cm) to medium(3cm) size tear of rotator cuff 4) Patient who agree to participate this clinical trial voluntarily with wirtten consent
Exclusion criteria
Exclusion criteria: Anyone who is consistent with one of these criteria cannot participate this trial. 1)Patient who have factors that can influence on results of trials (1) Shoulder arthritis. (2) Large to massive cuff tear(>3cm) (3) Past History of rotator cuff tear surgery(revision cases) (4) Rheumatoid arhtritis or other connective tissue disease (5) Isolated subscapularis tendon (6) Repair of subscapularis tendon (7) Symptomatic acromioclavicular joint arthritis (8) Severe adhesive capsulitis (9) Preoperative shoulder stiffness (foward flexion 120 degrees, external rotation 30 degrees, Internal rotation at back 3rd lumbar level, two or more of these) 2)Patients who have chronic disease that can influence on surgery, like Uncontrolled diabetes mellitus,hypertension, etc. 3)Complex regional pain syndrome patient 4)Patients who are expected to have adverse event in surgery (1)Patients who are on, or need anticoagulant medication. (2)Patients who have restriction of anticoagulant or antiplatelet agent. (3)Patients who have liver fuction disorder or renal function insufficiency (4)Patients who have severe systematic disease like severe anemia, etc. (5)Known HIV patient on medication 5)Female who is pregnant, may be pregnant, is lactating, or have no will to contracept during these clincial trials. 6)Patients who have history of participation of other clnical trials that need administration of medication or medical device within 4 weeks before participation of this clinical trial. 7)Other patients who are judged to be inappropriate to this study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder range of motion(FF, forward flexion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Range of motion(Forward flexion, External rotation at side, Internal rotator at back);VAS(Visual analogue score) score;Functional score(Constant, ASES(American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form), KSS(Korean Shoulder Score), SST(Simple Shoulder Test));Tendon recover rate via MRI study | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Hyun Park
Seoul National University Bundang Hospital
Outcome results
None listed