- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488039
Labroplasty in Cases of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
The goal of this clinical trial is to learn Labroplasty using the long head of biceps tendon works to patients with recurrent anterior shoulder instability with subcritical glenoid bone loss (<20%) and thinned or deficient anterior labrum .The main questions it aims to answer are:
Does Labroplasty using the long head of biceps improve the functional and radiological outcomes in patients with recurrent anterior shoulder instability with subcritical glenoid bone loss?
Participants will:
undergo arthroscopic labroplasty using the long head of biceps tendon Visit the clinic regularly for checkup and followup undergo MRI at 6 months to check radiological outcome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherif Walid Ibrahim, Assistant Lecturer
- Phone Number: 002 +201271377782
- Email: sherif_shibl@yahoo.com
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Recruiting
- Kasr El Aini Hospital
-
Contact:
- Sherif Walid Ibrahim, Assistant Lecturer
- Phone Number: 002 +201271377782
- Email: sherif_shibl@yahoo.com
-
Principal Investigator:
- sherif Walid Ibrahim, Assistant Lecturer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients with recurrent anterior shoulder instability with one or more events of anterior shoulder dislocation.
- Franceschi types 2 and 3 labral defects
- subcritical glenoid bone loss <20%
- positive anterior shoulder apprehension
Exclusion Criteria:
- Critical glenoid bones loss >20%
- Franceschi type 1 labral defect
- concomitant long head of biceps tendon pathology
- multidirectional instability
- prior arthroscopic shoulder stabilization surgery
- concomitant proximal humeral fractures
- concomitant Rotator cuff tears
- skeletally immature patients
- glenoid pathology
- Shoulder arthritis
- active infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with recurrent anterior shoulder instability with subcritical glenoid bone loss
Arthroscopic All-inside labroplasty using long head of biceps tendon in patients with recurrent anterior shoulder instability with subcritical glenoid bone loss (<20%) and thinned or deficient anterior labrum
|
Arthroscopic All-inside labral reconstruction using the long head of biceps tendon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Modified Rowe score postoperative
Time Frame: Assessed preoperative , then at 6 months and 12 months postoperative
|
Assessed preoperative , then at 6 months and 12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Constant shoulder score
Time Frame: assessed preoperative , then at 6 months and 12 months postopertive
|
assessed preoperative , then at 6 months and 12 months postopertive
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- DeFroda S,Bokshan S,Stern E,Sullivan K,Owens BD
- Zacharias AJ, Platt BN, Rutherford M, Kamineni S. Shoulder Anteroinferior Glenoid Labrum Reconstruction With the Long Head of the Biceps Tendon Restores Glenohumeral Stability: A Cadaveric Biomechanical Study. Arthroscopy. 2023 Feb;39(2):196-201. doi: 10.1016/j.arthro.2022.09.010. Epub 2022 Sep 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MD-439-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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