Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05558579

Use of Postop Sling After Biceps Tenodesis

Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University Hospitals Cleveland Medical Center · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERNo sling usePatients will not use standard of care sling

Timeline

Start date
2023-03-23
Primary completion
2024-09-26
Completion
2024-09-26
First posted
2022-09-28
Last updated
2024-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05558579. Inclusion in this directory is not an endorsement.