## Protocol Section
### Identification Module
**NCT ID:** NCT05558579

**Brief Title:** Use of Postop Sling After Biceps Tenodesis

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

#### Organization Study ID Info
**ID:** STUDY20220856
#### Organization
**Class:** OTHER
**Full Name:** University Hospitals Cleveland Medical Center
### Status Module
#### Completion Date
**Date:** 2024-09-26

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-22

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2024-09-26

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-23

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-09-28
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-23
**Study First Submit QC Date:** 2022-09-23
**Why Stopped:** Unable to enroll participants
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospitals Cleveland Medical Center

#### Responsible Party

**Investigator Affiliation:** University Hospitals Cleveland Medical Center

**Investigator Full Name:** Michael Karns, MD.

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Biceps Tenodesis

**Keywords:**

- shoulder rehabilitation

- shoulder sling

- biceps disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will continue using shoulder sling per standard of care

**Label:** Patients Using Sling

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Patients will not use shoulder sling postoperatively.

**Intervention Names:**

- Other: No sling use

**Label:** Patients Without Sling

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients Without Sling

**Description:** Patients will not use standard of care sling

**Name:** No sling use

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Percent of Complications As Measured by Medical Records

**Time Frame:** Up to 2 years

**Measure:** Degrees of Range-of-Motion As Measured by Physical Exam

**Time Frame:** Up to 30 minutes

**Description:** Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance

**Measure:** Strength as Measured by Physical Exam

**Time Frame:** Up to 30 minutes

#### Secondary Outcomes

**Description:** VAS is a 10-point scale with 0 being no pain and 10 being worst possible pain

**Measure:** Pain as Measured by the Visual Analog Scale

**Time Frame:** Up to 5 minutes

**Description:** ASES is a 17-item survey that has a score from 0-100

**Measure:** Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES)

**Time Frame:** Up to 15 minutes

**Description:** SST is a 12-item survey that has a score up to 12 points

**Measure:** Shoulder Function as Measured by the Simple Shoulder Test (SST)

**Time Frame:** Up to 15 minutes

**Description:** CMS is scored up to 100 points maximum

**Measure:** Shoulder Function as Measured by Constant Murley Score (CMS)

**Time Frame:** Up to 15 minutes

**Description:** WORC is a 21-item survey scored on a scale from 2,100 to 0

**Measure:** Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index

**Time Frame:** Up to 15 minutes

**Description:** SANE is a 1-item survey that has a score from 0-100

**Measure:** Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE)

**Time Frame:** Up to 5 minutes

**Description:** Yes/no survey asking about satisfaction with care

**Measure:** Percent of Patients Satisfied as Measured by Patient Survey

**Time Frame:** Up to 5 minutes

### Eligibility Module

**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.)

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cleveland

**Country:** United States

**Facility:** University Hospitals

**State:** Ohio

**Zip:** 44106

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospitals

**Name:** Michael Karns, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University Hospitals

**Name:** Kallie Chen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
