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No Sling Use After Biceps Tenodesis Surgery

N/A
Recruiting
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 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degrees of Range-of-Motion As Measured by Physical Exam
Percent of Complications As Measured by Medical Records
Strength as Measured by Physical Exam
Secondary outcome measures
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 more

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

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
340,085 Total Patients Enrolled
Michael Karns, MDPrincipal InvestigatorUniversity Hospitals
2 Previous Clinical Trials
97 Total Patients Enrolled
Kallie Chen, MDPrincipal InvestigatorUniversity Hospitals

Media Library

No sling use Clinical Trial Eligibility Overview. Trial Name: NCT05558579 — N/A
Biceps Tenodesis Research Study Groups: Patients Using Sling, Patients Without Sling
Biceps Tenodesis Clinical Trial 2023: No sling use Highlights & Side Effects. Trial Name: NCT05558579 — N/A
No sling use 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558579 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the foundational goals of this research endeavor?

"The primary evaluation metric of this clinical trial, monitored over the course of two years, will be Range-of-Motion as assessed through physical examination. Secondary objectives include Shoulder Function evaluated with Single Assessment Numeric Evaluation (SANE) – a 1-item survey scoring 0 to 100 - and American Shoulder and Elbow Surgeons (ASES), another 17-question survey ranging from 0 to 100; both used in conjunction with patients' self reported satisfaction surveys."

Answered by AI

Is the recruitment of participants still in progress for this experiment?

"As detailed in the records on clinicaltrials.gov, this medical trial is no longer recruiting patients as it was last updated 23rd September 2022. The trial first appeared online 1st November 2022 and, while not accepting applicants at present, there are presently other studies that need participants to join them."

Answered by AI

Is it possible for me to participate in this clinical investigation?

"This clinical trial is enrolling 150 individuals aged between 18 and 89 with biceps tenodesis. Crucially, applicants must display symptoms of biceps tendinitis or tenosynovitis, a partial-thickness rotator cuff tear, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear or biceps instability and be available for follow-up assessments for at least 6 months post treatment."

Answered by AI

Is this research undertaking open to individuals aged 18 and older?

"Applicants for this trial must have surpassed the legal age of consent and be below 89 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of Postop Sling After Biceps Tenodesis
Michael Karns, MD. 2023. "Use of Postop Sling After Biceps Tenodesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558579.
~42 spots leftby Sep 2024
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