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Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis

N/A
Waitlist Available
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Rotator Cuff Injury
  • Biceps Tendonitis
  • Tendonitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
Secondary study objectives
Comparison of Active External Rotation Between Treatment and Control Groups
Comparison of Active Forward Flexion Between Treatment and Control Groups
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Anatomic Long Head of Biceps Tensioning TechniqueExperimental Treatment1 Intervention
Patients that are randomized to the intervention group will undergo biceps tenodesis in a standardized, step-by-step protocol as outlined in a previously published and publicly available article.
Group II: Traditional Long Head of Biceps Tensioning TechniqueActive Control1 Intervention
The control group patient will undergo biceps tenotomy and tenodesis based on surgeon feel on appropriate tensioning of the tendon (Current practice). Of note, there is no universal method or gold standard on how the long head of the biceps should be tensioned during bicep tenodesis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anatomic Long Head of Biceps Tensioning Technique
2020
N/A
~210

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Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,252 Total Patients Enrolled
~39 spots leftby Jan 2026
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