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NCT06571695 · ClinicalTrials.gov registry record · NA
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
A NA study of Rotator Cuff Injuries and Tendinosis, sponsored by Loyola University.
- Completed
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 1
- Study location
NCT06571695: Completed NA study of Rotator Cuff Injuries and Tendinosis, sponsored by Loyola University.
NCT06571695 is a NA study of Rotator Cuff Injuries and Tendinosis that has completed, run by Loyola University. The registered enrollment target is 204 participants, above the 80-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (155% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06571695, a NA study of Rotator Cuff Injuries and Tendinosis, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The ASES form was created by the Society of the American Shoulder and Elbow Surgeons to help standardize outcome measures by both combining a physician-rated and patient rated section. The total maximum score (and best outcome) is 100. Half of the score is weighted for pain and the other half for function. The final pain score is calculated by subtracting the visual analog scale from 10 and multiplying by 5. For the functional portion, each of the 10 separate questions are on a scale from 0 to 3
Conditions Studied
Interventions
- PROCEDURE Anatomic Long Head of Biceps Tensioning Technique
- PROCEDURE Traditional Long Head of Biceps Tensioning Technique
Study Locations (1)
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2024-02-20 |
| Phase | NA |
What the finished NCT06571695 record still lists
NCT06571695 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (155% higher).
The record links to 3 conditions, with Rotator Cuff Injuries appearing as the primary indexed condition, and to 2 interventions - of which Anatomic Long Head of Biceps Tensioning Technique is the first listed.
NCT06571695 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06571695 about?
NCT06571695 is a clinical study titled "Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis". 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 ...
What is the current status of trial NCT06571695?
This trial is currently completed. It is a NA study. The enrollment target is 204 participants. The study started on 2020-10-27. Estimated completion is 2024-02-20.
What conditions does trial NCT06571695 study?
This clinical trial studies the following conditions: Rotator Cuff Injuries, Tendinosis, Biceps Tendon Disorder.
What interventions are being tested in trial NCT06571695?
The interventions under investigation include: Anatomic Long Head of Biceps Tensioning Technique (PROCEDURE), Traditional Long Head of Biceps Tensioning Technique (PROCEDURE).
Who is sponsoring clinical trial NCT06571695?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06571695 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06571695's enrollment target sits among peer trials
204 2nd of 10 the highest of 10 other Rotator Cuff Injuries trials
participants (enrollment target), bucketed by value
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