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No Sling Use After Biceps Tenodesis Surgery
N/A
Waitlist Available
Led By Michael Karns, MD
Research Sponsored by University Hospitals Cleveland Medical Center
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 up to 30 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial will help researchers understand if it is necessary to wear a sling after surgery for biceps tenodesis.
Who is the study for?
This trial is for patients who've had biceps tenodesis surgery and can follow up for at least 6 months. It's suitable for those with conditions like biceps tendinitis or tears, partial-thickness rotator cuff tears, and SLAP tear. People with previous similar surgeries, severe shoulder issues, or additional procedures that limit movement aren't eligible.
What is being tested?
The study tests if wearing a sling after biceps tenodesis surgery affects recovery. Participants are randomly placed in two groups: one wears the sling post-surgery while the other does not. Their shoulder strength, range-of-motion, and function through surveys will be compared over time to see if there's any difference.
What are the potential side effects?
Since this trial involves postoperative care rather than medication or invasive treatments, side effects may include discomfort from not using a sling or potential delays in healing due to increased activity without the support of a sling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Strength as Measured by Physical Exam
Secondary study objectives
Pain as Measured by the Visual Analog Scale
Percent of Patients Satisfied as Measured by Patient Survey
Shoulder Function as Measured by Constant Murley Score (CMS)
+4 moreAwards & 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: Patients Without SlingExperimental Treatment1 Intervention
Patients will not use shoulder sling postoperatively.
Group II: Patients Using SlingActive Control1 Intervention
Patients will continue using shoulder sling per standard of care
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Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
327 Previous Clinical Trials
344,975 Total Patients Enrolled
Michael Karns, MDPrincipal InvestigatorUniversity Hospitals
2 Previous Clinical Trials
97 Total Patients Enrolled
Kallie Chen, MDPrincipal InvestigatorUniversity Hospitals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my shoulder that limits my movement.I am having surgery for issues like shoulder tendonitis, tears, or bursitis.I have had surgery on the same side's upper arm before.I have severe shoulder movement and strength issues due to conditions like arthritis or muscle paralysis.
Research Study Groups:
This trial has the following groups:- Group 1: Patients Using Sling
- Group 2: Patients Without Sling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.