Back to resultsArthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
Primary Purpose
Partial Thickness Rotator Cuff Tears
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Augmentation with subacromial bursa + acromioplasty
Rotator cuff debridement + acromioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Partial Thickness Rotator Cuff Tears focused on measuring partial thickness, bursal side, rotator cuff, full thickness, subacromial bursa
Eligibility Criteria
Inclusion Criteria: bursal side rotator cuff tears in MRI sections Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months 25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side Exclusion Criteria: Previous surgery tears greater than 50% or 6 mm
Sites / Locations
- SBU Prof. Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rotator cuff debridement + acromioplasty
Augmentation with subacromial bursa + acromioplasty
Arm Description
Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients.
Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients.
Outcomes
Primary Outcome Measures
Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI.
Our Primary Outcome Measure is to investigate the effects of biological augmentation with subacromial bursa in arthroscopic bursal-sided partial thickness rotator cuff repair with postoperative MRI and functional scores with Constant-Murley and Ases scores.
Secondary Outcome Measures
Full Information
NCT ID
NCT05823428
First Posted
March 21, 2023
Last Updated
April 19, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT05823428
Brief Title
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
Official Title
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Thickness Rotator Cuff Tears
Keywords
partial thickness, bursal side, rotator cuff, full thickness, subacromial bursa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotator cuff debridement + acromioplasty
Arm Type
Active Comparator
Arm Description
Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients.
Arm Title
Augmentation with subacromial bursa + acromioplasty
Arm Type
Active Comparator
Arm Description
Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients.
Intervention Type
Procedure
Intervention Name(s)
Augmentation with subacromial bursa + acromioplasty
Intervention Description
Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff debridement + acromioplasty
Intervention Description
Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B
Primary Outcome Measure Information:
Title
Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI.
Description
Our Primary Outcome Measure is to investigate the effects of biological augmentation with subacromial bursa in arthroscopic bursal-sided partial thickness rotator cuff repair with postoperative MRI and functional scores with Constant-Murley and Ases scores.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
bursal side rotator cuff tears in MRI sections
Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months
25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side
Exclusion Criteria:
Previous surgery
tears greater than 50% or 6 mm
Facility Information:
Facility Name
SBU Prof. Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34040
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
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