Use of Postop Sling After Biceps Tenodesis

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Biceps Tenodesis
• Intervention / Treatment: Other: No sling use

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: No sling use; Patients will not use standard of care sling

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Michael Karns, MD, University Hospitals; Principal Investigator: Kallie Chen, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): September 26, 2024
• Study Completion (Estimated): September 26, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: shoulder rehabilitation; shoulder sling; biceps disorders
• Other Study ID Numbers: STUDY20220856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No