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

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT05823428
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Partial Thickness Rotator Cuff Tears	Procedure: Augmentation with subacromial bursa + acromioplasty; Procedure: Rotator cuff debridement + acromioplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rotator cuff debridement + acromioplasty Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients.	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
Active Comparator: Augmentation with subacromial bursa + acromioplasty Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients.	Procedure: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBU Prof. Cemil Tascioglu City Hospital	Istanbul		Turkey	34040

Sponsors and Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bulent KARSLIOGLU, Orthopedics and Traumatology specialist,Chief assistant, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• ClinicalTrials.gov Identifier: NCT05823428
• Other Study ID Numbers: Subacromial bursa Augmentation
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 21, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bulent KARSLIOGLU, Orthopedics and Traumatology specialist,Chief assistant, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: partial thickness; bursal side; rotator cuff; full thickness; subacromial bursa
• Additional relevant MeSH terms: Rotator Cuff Injuries

Study Results

No Results Posted as of Apr 21, 2023