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

NCT ID: NCT05823428

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-01-01

Brief Summary

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

Detailed Description

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Conditions

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Partial Thickness Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotator cuff debridement + acromioplasty

Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients.

Group Type ACTIVE_COMPARATOR

Rotator cuff debridement + acromioplasty

Intervention Type 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

Augmentation with subacromial bursa + acromioplasty

Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients.

Group Type ACTIVE_COMPARATOR

Augmentation with subacromial bursa + acromioplasty

Intervention Type 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

Interventions

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Augmentation with subacromial bursa + acromioplasty

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

Rotator cuff debridement + acromioplasty

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

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Bulent KARSLIOGLU

Orthopedics and Traumatology specialist,Chief assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SBU Prof. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Subacromial bursa Augmentation

Identifier Type: -

Identifier Source: org_study_id

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