Use of Postop Sling After Biceps Tenodesis

Not Applicable

Withdrawn

• Conditions: Biceps Tenodesis
• Interventions: Other: No sling use

• Registration Number: NCT05558579
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2023-03-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients Without Sling	No sling use	Patients will not use shoulder sling postoperatively.

Primary Outcome Measures

Name	Time	Method
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	Up to 30 minutes	Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States