N/A N=167 Randomized Single-blind Treatment

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

Biceps Tendon Disorder · Tendinosis · Rotator Cuff Injuries

Bottom Line

View on ClinicalTrials.gov: NCT06571695 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups — 47.1; 37.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Anatomic Long Head of Biceps Tensioning Technique (Procedure); Traditional Long Head of Biceps Tensioning Technique (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Loyola University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	78.3; 77.3	—
PRIMARY Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	78.3; 77.3	—
PRIMARY Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	78.3; 77.3	—
PRIMARY Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	78.3; 77.3	—
PRIMARY Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	78.3; 77.3	—
SECONDARY Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	2.2; 2.9	—
SECONDARY Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	2.2; 2.9	—
SECONDARY Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	2.2; 2.9	—
SECONDARY Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	2.2; 2.9	—
SECONDARY Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	2.2; 2.9	—
SECONDARY Comparison of Active Forward Flexion Between Treatment and Control Groups	150.3; 139.0	—
SECONDARY Comparison of Active Forward Flexion Between Treatment and Control Groups	150.3; 139.0	—
SECONDARY Comparison of Active Forward Flexion Between Treatment and Control Groups	150.3; 139.0	—
SECONDARY Comparison of Active Forward Flexion Between Treatment and Control Groups	150.3; 139.0	—
SECONDARY Comparison of Active External Rotation Between Treatment and Control Groups	45.4; 43.6	—
SECONDARY Comparison of Active External Rotation Between Treatment and Control Groups	45.4; 43.6	—
SECONDARY Comparison of Active External Rotation Between Treatment and Control Groups	45.4; 43.6	—
SECONDARY Comparison of Active External Rotation Between Treatment and Control Groups	45.4; 43.6	—

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.

Eligibility Criteria

Inclusion Criteria

Patients at least 18 years of age undergoing arthroscopic shoulder surgery
Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

Exclusion Criteria

Previous shoulder surgery involving the long head of the biceps tendon
Younger than 18 years old
Current pregnancy. As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06571695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.