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OpenTrials
Completed

NCT Number: NCT05823428

Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears

The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.

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Key information

Conditions

Partial Thickness Rotator Cuff Tears

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, 34040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmentation with subacromial bursa + acromioplasty

Procedure

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

Rotator cuff debridement + acromioplasty

Procedure

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 outcomes

  1. Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI.

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2023
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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