Use of Postop Sling After Biceps Tenodesis

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Biceps Tenodesis

Intervention / Treatment
-----------------
* Other: No sling use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability Patients with minimum 6-month follow-up Exclusion Criteria: Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty Patients with history of prior ipsilateral proximal biceps procedures Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients Using Sling<br>Patients will continue using shoulder sling per standard of care | |
| Experimental: Patients Without Sling<br>Patients will not use shoulder sling postoperatively. | Other: No sling use<br>* Patients will not use standard of care sling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Complications As Measured by Medical Records |  | Up to 2 years | 
| Degrees of Range-of-Motion As Measured by Physical Exam |  | Up to 30 minutes | 
| Strength as Measured by Physical Exam | Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance | Up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Measured by the Visual Analog Scale | VAS is a 10-point scale with 0 being no pain and 10 being worst possible pain | Up to 5 minutes | 
| Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) | ASES is a 17-item survey that has a score from 0-100 | Up to 15 minutes | 
| Shoulder Function as Measured by the Simple Shoulder Test (SST) | SST is a 12-item survey that has a score up to 12 points | Up to 15 minutes | 
| Shoulder Function as Measured by Constant Murley Score (CMS) | CMS is scored up to 100 points maximum | Up to 15 minutes | 
| Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index | WORC is a 21-item survey scored on a scale from 2,100 to 0 | Up to 15 minutes | 
| Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE) | SANE is a 1-item survey that has a score from 0-100 | Up to 5 minutes | 
| Percent of Patients Satisfied as Measured by Patient Survey | Yes/no survey asking about satisfaction with care | Up to 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder rehabilitation, shoulder sling, biceps disorders