NCT05558579

Use of Postop Sling After Biceps Tenodesis

Withdrawn NA Last updated 24 April 2024

What this trial tests

NA trial testing No sling use in Biceps Tenodesis. Withdrawn.

Timeline

23 March 2023

Primary endpoint
26 September 2024

26 September 2024

Quick facts

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	23 March 2023
Primary completion	26 September 2024
Estimated completion	26 September 2024
Sites	1 location across United States

Drugs / interventions tested

• No sling use

Conditions studied

• Biceps Tenodesis — all drugs for Biceps Tenodesis →

Sponsor

University Hospitals Cleveland Medical Center

Who can join

Adults 18 to 89, any sex, with Biceps Tenodesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.