Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571695
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long Head of the Biceps Subpectoral Tenodesis Anatomic vs Traditional Tensioning Technique During Rotator Cuff Repair A Randomized Prospective Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the clinical impact of restoring the anatomic-tension relationship of the long head of the biceps LHB when performing a biceps tenotomy and tenodesis The main question it aims to answer is whether anatomic tensioning will improve functional outcome scores and decrease postoperative complications The investigators hypothesize that through a standardized method of anatomically tensioning the LHB tendon during tenodesis patient outcomes will improve Researchers will compare these outcomes to a control group receiving the traditional tensioning technique Participants will be randomized to either the anatomic tensioning treatment group or the traditional tensioning control group
Detailed Description:
The long head of the biceps can be a source of anterior shoulder pain that is primarily due to inflammation or instability of the long head of the biceps LHB tendon Patients that fail non-operative management become candidates for biceps tenotomy and tenodesis Currently there is no universal protocol or gold standard for how the LHB tendon is tensioned At the investigators institution the LHB is tensioned based on individual surgeon feel for the correct tensioning The purpose of this study is to conduct a randomized single-blinded prospective study comparing patients with the current regimen of bicep tensioning vs utilizing a standardized method of anatomically tensioning the LHB tendon The primary aim of assessing change in the American Shoulder and Elbow Surgeon ASES scores from baseline to post-surgery between the control and intervention groups will be assessed using a students t-test In addition longitudinal mixed effects models will be used to estimate changes in ASES scores over all time-points using a random effect for surgeon Other relevant patient characteristics such as age sex and Charlson score will be included to explore the adjusted relationship of the intervention and outcomes over time A secondary aim of this study is to collect specific measurements of the myotendinous junction of the LHB tendon to potentially establish if any characteristics predispose patients to developing pathology of the LHB tendon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None