N/A
Completed N=167
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
Biceps Tendon Disorder · Tendinosis · Rotator Cuff Injuries
Source: ClinicalTrials.gov NCT06571695 ↗
Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups — 47.1; 37.1 units on a scale
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.
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 | — |
| 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 External Rotation Between Treatment and Control Groups |
45.4; 43.6 | — |
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.
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. Informational only — not medical advice.