Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
1 other identifier
interventional
40
1 country
1
Brief Summary
The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedApril 21, 2023
April 1, 2023
1.9 years
March 21, 2023
April 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
18 months
Study Arms (2)
Rotator cuff debridement + acromioplasty
ACTIVE COMPARATORGroup A was formed by performing rotator cuff debridement + acromioplasty in 18 patients.
Augmentation with subacromial bursa + acromioplasty
ACTIVE COMPARATORGroup B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
- % or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side
You may not qualify if:
- Previous surgery
- tears greater than 50% or 6 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SBU Prof. Cemil Tascioglu City Hospital
Istanbul, 34040, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopedics and Traumatology specialist,Chief assistant
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 21, 2023
Study Start
February 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2022
Last Updated
April 21, 2023
Record last verified: 2023-04