Arthroscopic partial repair with or without biodegradable subacromial spacer (InSpace Balloon): a retrospective case control study
- Conditions
- Rotator Cuff Tear
- Registration Number
- DRKS00014725
- Lead Sponsor
- 3rd Department of OrthopaedicsHYGEIA Hospital of Athens
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
Age >50
- patients who had diagnosed symptomatic, massive or irreparable rotator cuff tear
- patients who have undergone an arthroscopic partial repair in our hospital as the method of treatment (with or without InSpace Balloon)
-patients with a minimum follow-up of 12 months
Exclusion Criteria
- Age <50
- Previous operation on the same joint
- Glenohumeral arthritis
- Irreparable subscapularis tear
- Rheumatoid arthritis or other systematic diseases
- Serious psychiatric diseases
- active shoulder infection
- uncontrolled diabetes mellitus
- Coagulopathy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For the clinical assessment of the patients, the Constant Score and the American Shoulder and Elbow Surgeons Shoulder Score (ASES) has been documented. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. <br>The rate of success will be calculated by the difference in Constant and ASES scores from pre-operation minus the final Constant and ASES score. Particularly, we established two separate primary criteria for the patients which were categorized as succeeded-treated: a. a bigger than 10.4 positive difference between the final follow-up Constant score and the initial Constant score (this is the officially established minimal clinically important difference or MCID) and b. a bigger than 17 positive difference between the final follow-up ASES score and the initial ASES score (this is the officially established minimal clinically important difference or MCID).
- Secondary Outcome Measures
Name Time Method <br>For the functional assessment of the patients, the Range of Motion (RoM) was measured in forward flexion, external rotation (from neutral position), external rotation (from 90° abduction) and internal rotation of the operated limb. Each patient's evaluation was documented in our database on 10 days, 30 days, 3 months, 6 months, 12 months, 24 months and 36 months (when available) postoperatively. <br>Finally, we plan to search our department’s archives to find out: a. the demographic characteristics of the two groups, b. the type of lesion c. possible complications, d. readmissions and e. reoperations<br>