University Hospitals Cleveland Medical Center
Michael Karns, MD.
The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this. This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found.
Biceps Tenodesis
No sling use
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 150 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis |
Actual Study Start Date : | March 23, 2023 |
Estimated Primary Completion Date : | September 26, 2024 |
Estimated Study Completion Date : | September 26, 2024 |
Arm | Intervention/treatment |
---|---|
No Intervention: Patients Using Sling Patients will continue using shoulder sling per standard of care |
|
Experimental: Patients Without Sling Patients will not use shoulder sling postoperatively. |
Ages Eligible for Study: | 18 Years to 89 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University Hospitals
Cleveland, Ohio, United States, 44106